Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
23836 A II 5/18/2010 VALDEPHARM ESTRADIOL BENZOATE (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE
23837 A II 6/2/2010 UNIMARK REMEDIES LTD MONTELUKAST SODIUM (PROCESS A) (ESUB) AS MANUFACTURED IN GUJARAT INDIA
23838 A II 6/17/2010 BGP HEALTHCARE PRIVATE LTD NICOTINE POLACRILEX USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA Page 708
4Q2012 2Q2014EXCEL
23839 A II 4/19/2010 GLAND PHARMA LTD HEPARIN SODIUM USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23840 A V 6/9/2010 NOVOCOL PHARMACEUTICAL CANADA INC NOVOCOL PHARMACEUTICAL OF CANADA INC STERILE MANUFACTURING VALIDATION
(ESUB) AS LOCATED IN ONTARIO CANADA
23841 A III 5/17/2010 JIANGSU ZHONGJIN MATAI MEDICINAL
PACKAGING CO LTD
ALUMINIUM FOILS PACKAGING FOR MEDICINE AS MANUFACTURED IN JIANGSU
PROVINCE, P.R. CHINA
23842 A II 5/27/2010 CATALENT PHARMA SOLUTIONS LLC DRONABINOL CAPSULES USP 2.5MG, 5.0MG, 10.0MG (CIII) SA MANUFACTURED IN
SOMERSET, NJ
23843 A II 5/24/2010 MACLEODS PHARMACEUTICALS LTD TOLTERODINE TARTRATE AS MANUFACTURED IN GUJARAT, INDIA
23844 A II 6/3/2010 SIGMAPHARM LABORATORIES LLC AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION) (ESUB) AS
MANUFACTURED IN BENSALEM, PA
23845 I II 5/25/2010 XELLIA PHARMACEUTICALS APS MUPIROCIN USP, NON-STERILE AS MANUFACTURED IN TAIZHOU ZHEJIANG, P.R. CHINA
23846 A III 5/24/2010 AMPACET CORP 482521 BEIGE SLIP PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
23847 A II 5/20/2010 ALP PHARM BEIJING CO LTD ZOLEDRONIC ACID AS MANUFACTURED IN SHANDONG, CHINA FOR ALP PHARMA BEIJING
CO LTD
23848 A II 5/10/2010 LUSOCHIMICA SPA FORMOTEROL FUMARATE DIHYDRATE AS MANUFACTURED IN PISA, ITALY AND
LOMAGNA (LC), ITALY
23849 A III 6/1/2010 OKURA INDUSTRIAL CO LTD OKR EMBOSSED POLYPROPYLENE LINER AS MANUFACTURED IN KAGAWA
PREFECTURE, JAPAN
23850 A II 2/10/2011 LUPIN LTD DARUNAVIR ETHANOLATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
23851 A III 4/29/2010 PLASTICON INDUSTRIAL LTD USA APPLICATOR AS MANUFACTURED IN TOKOL, HUNGARY
23852 A II 5/24/2010 PCAS DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN TURKU, FINLAND
23853 A II 6/2/2010 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
LEVETIRACETAM USP (PROCESS II) AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
23854 A II 6/2/2010 HETERO LABS LTD DARUNAVIR AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23855 A II 6/3/2010 HARMAN FINOCHEM LTD FENOFIBRIC ACID AS MANUFACTURED IN MAHARASHTRA, INDIA
23856 A II 5/27/2010 PRODUCTOS QUIMICOS NATURALES SA DE
CV
17 ALPHA-ESTRADIOL AS MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO
23857 A III 5/19/2010 INGENIA POLYMERS CORP INGENIA POLYMERS 1020 FILLED WHITE FOR USE IN PACKAGING MATERIALS AS
MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA AND HOUSTON, TEXAS
23858 A II 5/28/2010 ZHUHAI UNITED LABORATORIES CO LTD MEROPENEM USP, NON-STERILE AS MANUFACTURED IN GUANGDONG, P.R. CHINA
23859 A II 5/27/2010 MYLAN LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS) ( ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
23860 A II 6/4/2010 CADILA HEALTHCARE LTD BENZOYL PEROXIDE HYDROUS (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
23861 A IV 6/4/2010 FONA INTERNATIONAL INC 805.219 BANANA FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
23862 A II 5/20/2010 ST GOBAIN PERFORMANCE PLASTICS CORP TYGON 3350 SILICONE TUBING AS MANUFACTURED IN BANGALORE, INDIA
23863 A II 6/28/2010 APICORE LLC FONDAPARINUX SODIUM (ESUB) AS MANUFACTURED IN SOMERSET NJ
23864 A II 6/3/2010 MSN PHARMACHEM PVT LTD SITAGLIPTIN PHOSPHATE MONOHYDRATE (ROUTE CODE SG) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
23865 A II 6/7/2010 HETERO DRUGS LTD LEVOFLOXACIN HEMIHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23866 A II 6/28/2010 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
ISA (INTERMEDIATE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR
ORCHID CHEMICALS & PHARMACEUTICALS LTD
23867 A II 6/4/2010 EUTICALS SPA SODIUM MYCOPHENOLATE AS MANUFACTURED IN ROZZANO (MI) ITALY
23868 P *** PENDING FILING REVIEW ***
Page 709
4Q2012 2Q2014EXCEL
23869 A IV 6/7/2010 XIANGSHAN JINAN IMPORT & EXPORT CO
LTD
HARD EMPTY GELATIN CAPSULES AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
23870 A II 7/20/2010 TRIS PHARMA INC METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)
(ESUB) AS MANUFACTURED IN MONMOUTH JUNCTION NJ
23871 A II 11/29/2010 CADILA PHARMACEUTICALS LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
23872 I II 6/10/2010 YUNG SHIN PHARMACEUTICAL INDUSTRIAL
CO LTD
CEPHALEXIN USP YUNG SHIN AS MANUFACTURED IN TAICHUNG, TAIWAN, R.O.C.
23873 A II 6/10/2010 MYLAN LABORATORIES LTD DARUNAVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23874 A IV 6/9/2010 EVONIK INDUSTRIES AG RESOMER R SR FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN
INGELHEIM, GERMANY
23875 A II 6/9/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD FLUOCINOLONE ACETONIDE (PROCESS II) AS MANUFACTURED IN RHO MILAN ITALY FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
23876 A II 5/31/2010 BIOTIKA AS POLYMYXIN B SULFATE AS MANUFACTURED IN SLOVENSKA LUPCA, SLOVAKIA
23877 A II 5/31/2010 AREVIPHARMA GMBH METAXALONE AS MANUFACTURED IN RADEBEUL, GERMANY
23878 A II 5/31/2010 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA SO3 AS MANUFACTURED IN LJUBLJANA,
SLOVENIA
23879 A II 6/5/2010 NUVIEW LIFE SCIENCES SODIUM IODINE (I-123) DRY IODINE RADIOCHEMICAL AS MANUFACTURED IN DENTAON,
TX
23880 A II 6/9/2010 CENTAUR PHARMACEUTICALS PRIVATE LTD BRIMONIDINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA
23881 A II 6/29/2010 TORRENT PHARMACEUTICALS LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
23882 A IV 6/9/2010 UNGERER AND CO NATURAL AND ARTIFICIAL ORANGE FLVP FO-9464 AS MANUFACTURED IN BETHLEHEM,
PA
23883 A II 8/4/2010 MALLINCKRODT INC OPIUM TINCTURE 2% (ESUB) AS MANUFACTURED IN ST LOUIS MO
23884 A II 6/8/2010 INDENA SPA N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-DEACETYLPACLITAXEL INTERMEDIATE) AS
MANUFACTURED IN SETTALA (MI), ITALY
23885 A II 4/29/2010 MELODY HEALTHCARE PVT LTD RAMIPRIL AS MANUFACTURED IN MAHARASHTRA, INDIA
23886 A II 8/30/2010 INDENA SPA DOCETAXEL (ESUB) AS MANUFACTURED IN MILAN ITALY
23887 I II 6/15/2010 SEQUENT SCIENTIFIC LTD PRAZIQUANTEL AS MANUFACTURED IN KARNATAKA, INDIA
23888 A II 6/8/2010 PERRIGO API LTD MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL
23889 A II 6/15/2010 MSN PHARMACHEM PVT LTD OSELTAMIVIR PHOSPHATE [ROUTE CODE: OT] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
23890 A II 4/27/2010 BRIDGE ORGANICS CO CRYSTALLINE LACTONEDIOL AS MANUFACTURED IN VICKSBURG, MI
23891 A II 6/29/2010 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
CEFUROXIME AXETIL (CRYSTALLINE) (NON-STERILE BULK API) (ESUB) AS
MANUFACTURED IN ALATHUR KANCHEEPURAM DISTRICT INDIA
23892 A II 6/7/2010 BIOCON LTD HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE) AS MANUFACTURED IN
BANGALORE, INDIA.
23893 A III 6/16/2010 FLOW DRY TECHNOLOGY INC DESICCANT PRODUCTS AS MANUFACTURED IN BELEN, NM
23894 A III 6/15/2010 CORMACK PACKAGING PTY LTD CORMACK TAMPER EVIDENT (TE) CLOSURES AS MANUFACTURED IN NEW SOUTH
WALES, AUSTRALIA
23895 A II 6/18/2010 NEULAND LABORATORIES LTD PARICALCITOL, USP AS MANUFACTURED IN ANDHRA PRADESH INDIA
23896 A II 6/18/2010 APOTEX PHARMACHEM INDIA PVT LTD ZOLMITRIPTAN AS MANUFACTURED IN KARNATAKA, INDIA
23897 A II 7/7/2010 CML EUROPE BV MALATHION USP (ESUB) AS MANUFACTURED IN WEERT THE NETHERLANDS
23898 A II 6/29/2010 AUROBINDO PHARMA LTD MODAFINIL USP (NON-STERILE DRUG SUBSTANCE) (ESUB) ANDHRA PRADESH INDIA
23899 A II 6/18/2010 SYMBIOTEC PHARMALAB LTD PREDNISOLONE SODIUM PHOSPHATE USP AS MANUFACTURED IN INDORE, INDIA
Page 710
4Q2012 2Q2014EXCEL
23900 A II 6/22/2010 MSN LABORATORIES LTD PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE [ROUTE CODE PP] AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
23901 A II 6/30/2010 NOVARTIS PHARMACEUTICALS CORP FLUVASTATIN DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RINGASKIDDY CO CORK
IRELAND FOR NOVARTIS PHARMACEUTICAL CORPORATION
23902 A II 7/2/2010 NOVARTIS PHARMACEUTICALS CORP VALSARTAN DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RINGASKIDDY CO CORK
IRELAND FOR NOVARTIS PHARMACEUTICAL CORPORATION
23903 A IV 6/22/2010 FONA INTERNATIONAL INC 825.0275U CHERRY FLAVOR NAT & ART AS MANUFACTURED IN GENEVA IL
23904 A III 6/18/2010 AMPACET CORP 474187 GREEN PP MB AS MANUFACTURED IN DERRIDER LA, CATERSVILLE GA, HEATH
OH, AND TERRE HAUTE IN
23905 A II 7/12/2010 KD PHARMA BEXBACH GMBH OMEGA-3-ACIDS ETHYL ESTER (ESUB) AS MANUFACTURED IN BEXBACH GERMANY
23906 A II 6/14/2010 YUNG ZIP CHEMICAL IND CO LTD CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TACHIA TAICHUNG TAIWAN ROC
23907 I II 6/8/2010 SINTENOVO SA DE CV RABEPRAZOLE SODIUM AS MANUFACTURED IN JUAREZ MEXICO
23908 A II 6/18/2010 PCAS OLOPATADINE HCI AS MANUFACTURED IN TURKU FINLAND FOR PCAS
23909 A II 6/18/2010 YUNG ZIP CHEMICAL IND CO LTD DICLOFENAC EPOLAMINE AS MANUFACTURED IN TACHIA TAICHUNG TAIWAN ROC
23910 A II 6/23/2010 ACTAVIS GROUP PTC EHF CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN TAMIL NADU, INDIA
23911 A II 7/7/2010 PRONOVA BIOPHARMA NORGE AS EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E) (ESUB) AS MANUFACTURED IN ISLE OF
LEWIS SCOTLAND UK
23912 A IV 6/21/2010 TERRENE PHARMA PVT LTD EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN GUJARAT, INDIA
23913 A III 6/18/2010 DYNEON GMBH IMPROVED PFA POLYMER DISPERSIONS AS MANUFACTURED IN BURGKIRCHEN,
GERMANY
23914 A II 6/23/2010 INKE SA SALMETEROL XINAFOATE AS MANUFACTURED IN (BARCELONA) SPAIN
23915 A II 6/23/2010 RAKS PHARMA PVT LTD DIVALPROEX SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23916 A II 6/25/2010 CRYSTAL PHARMA SAU MOMETASONE FUROATE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID),
SPAIN
23917 A IV 6/25/2010 ROQUETTE FRERES PEA STARCH HYDROXYPROPYL PREGELATINIZED (LYCOAT+F23803 RS) AS
MANUFACTURED IN LESTREM, FRANCE AND LENGRAIN, FRANCE
23918 A II 12/29/2010 APICORE LLC CABERGOLINE (ESUB) AS MANUFACTURED IN SOMERSET NJ
23919 A IV 6/25/2010 ROQUETTE FRERES PEA STARCH HYDROXYPROPYL (LYCOAT NG) AS MANUFACTURED IN LESTREM,
FRANCE AND LENGRAIN, FRANCE
23920 A II 6/28/2010 BIOVET JOINT STOCK CO TESTOSTERONE ENANTHATE AS MANUFACTURED IN PESHTERA, BULGARIA
23921 A II 6/25/2010 STERLING SPA NOMEGESTROL ACETATE AS MANUFACTURED IN PERUGIA, ITALY
23922 A III 6/28/2010 DYNIC USA HT13 THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR
23923 A II 6/29/2010 NUVIEW LIFE SCIENCES INDIUM CHLORIDE (111IN) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TX
23924 A II 8/5/2010 APICORE LLC BUSULFAN USP (ESUB) AS MANUFACTURED IN SOMERSET NJ
23925 A II 6/8/2010 SHASUN PHARMACEUTICALS LTD IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN CUDDALORE, INDIA
23926 A II 6/25/2010 HAINAN POLY PHARMACEUTICAL CO LTD DESLORATADINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
23927 A II 6/29/2010 MYLAN LABORATORIES LTD ROSIGLITAZONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23928 A IV 6/23/2010 EVONIK INDUSTRIES AG RESOMER (R) RP D FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN
INGELHEIM, GERMANY
23929 A II 6/25/2010 PROVENTUS LIFE SCIENCES PVT LTD TROSPIUM CHLORIDE AS MANUFACTURED IN CHENNAI, INDIA
Page 711
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23930 A II 6/29/2010 PHARMACEUTICAL WORKS POLPHARMA SA SILDENAFIL CITRATE AS MANUFACTURED STAROGARD GDANSKI, POLAND
23931 A III 6/30/2010 CORADIN SAS DUAL VIALS SYSTEM AS MANUFACTURED IN MOUANS-SARTOUX, FRANCE
23932 A III 6/29/2010 MITSUBISHI PLASTICS INC TECHBARRIER SERIES AS MANUFACTURED IN KYOTO, JAPAN AND SHIGA, JAPAN FOR
MITSUBISHI PLASTICS INC
23933 A II 6/30/2010 ERREGIERRE SPA ENTACAPONE AS MANUFACTURED IN SAN PAOLO D ARGON (BG), ITALY
23934 A II 6/28/2010 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
TESTOSTERONE UNDECANOATE, NON-STERILE, BULK DRUG SUBSTANCE AS
MANUFACTURED IN ZHEJIANG, P.R. CHINA
23935 A II 6/21/2010 OLON SPA RITONAVIR AS MANUFACTURED IN MULAZZANO (LO), ITALY
23936 A II 7/1/2010 KYOWA HAKKO KIRIN CO LTD ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN
23937 A II 6/30/2010 RA CHEM PHARMA LTD ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23938 A IV 7/2/2010 COMED CHEMICALS LTD EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN GUJARAT, INDIA
23939 I II 6/29/2010 DERIVADOS QUIMICOS SA FINE CHEMICALS SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN
23940 A II 6/28/2010 SMRUTHI ORGANICS LTD FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
23941 A II 7/2/2010 APOTEX PHARMACHEM INDIA PVT LTD CANDESARTAN CILEXETIL AS MANUFACTURED IN BRANTFORD, CANADA AND
BANGALORE, INDIA
23942 A II 6/29/2010 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
ESTRADIOL USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
ZHEJIANG P.R. CHINA
23943 A IV 7/2/2010 FONA INTERNATIONAL INC 926.0425U N-C VANILLA FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
23944 A II 7/6/2010 EMCURE PHARMACEUTICALS LTD BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
23945 A II 7/6/2010 MSN LABORATORIES LTD PALIPERIDONE [ROUTE CODE-PA] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23946 A II 7/6/2010 RANBAXY LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE, USP (PROCESS 2; SITE TOANSA) AS
MANUFACTURED IN PUNJAB, INDIA
23947 A II 6/14/2010 ZHEJIANG SUPOR PHARMACEUTICALS CO
LTD
MITOTANE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
23948 A II 7/2/2010 VALDEPHARM ESTRADIOL VALERATE AS MANUFACTURED IN VAL DE REUIL, FRANCE
23949 A II 6/18/2010 ALP PHARM BEIJING CO LTD IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN SICHUAN PROVINCE, P.R. CHINA
23950 A IV 7/1/2010 UNGERER AND CO NATURAL AND ARTIFICIAL LEMON FLVP FT-4174 AS MANUFACTURED IN BETHLEHEM, PA
23951 A II 6/1/2010 ALP PHARM BEIJING CO LTD VINORELBINE TARTRATE AS MANUFACTURED IN HUBEI PROVINCE, P.R. CHINA FOR ALP
PHARM BEIJING CO LTD
23952 A III 5/26/2010 COLORTECH INC 11287-16 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN,
TN AND ONTARIO, CANADA
23953 A III 5/26/2010 COLORTECH INC 10505-14 KOSHER ANTIFOG POLYETHYLENE CONCENTRATE AS MANUFACTURED IN
MORRISTOWN, TN AND ONTARIO, CANADA
23954 A II 7/7/2010 SOUTHWEST SYNTHETIC PHARMACEUTICAL
CO LTD
ALLOPURINOL AS MANUFACTURED IN CHONGQING, P.R. CHINA
23955 A III 7/7/2010 GEPACK SA PET PACKAGING AS MANUFACTURED IN AZAMBUJA, PORTUGAL
23956 A III 6/29/2010 NOLATO JAYCARE LTD 20ML POLYETHYLENE WHITE ROUND BOTTLE AS MANUFACTURED IN NEW CASTLE
UPON TYNE, ENGLAND
23957 A III 6/30/2010 E SAENG TECHNOPACK CO LTD CONTAINER AND CLOSURE AS MANUFACTURED IN CHUNGNAM, KOREA
23958 A II 7/8/2010 NORAC INC RSN-01314 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA
23959 A II 5/21/2010 NTP RADIOISOTOPES PTY LTD FISSION MOLYBDENUM-99 (PRODUCED FROM LOW ENRICHED URANIUM (LEU)) AS
MANUFACTURED IN PRETORIA, REPUBLIC OF SOUTH AFRICA
23960 A II 7/13/2010 EUTICALS SPA DIACEREIN (PROCESS I) AS MANUFACTURED IN LODI, ITALY
Page 712
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23961 A II 7/13/2010 EUTICALS SPA DIACEREIN (PROCESS II) AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY
23962 A II 7/8/2010 CONCORD BIOTECH LTD CYCLOSPORINE USP AS MANUFACTURED in AHMEDABAD, INDIA
23963 A II 7/12/2010 SAURAV CHEMICALS LTD HOMATROPINE METHYLBROMIDE USP AS MANUFACTURED IN PUNJAB, INDIA
23964 A IV 7/12/2010 FONA INTERNATIONAL INC 915.0113U STRAWBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
23965 A II 7/28/2010 UNIMARK REMEDIES LTD SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
23966 A II 7/9/2010 CALYX CHEMICALS AND PHARMACEUTICALS
LTD
LUMEFANTRINE AS MANUFACTURED IN MAHARASHTRA INDIA
23967 A II 7/12/2010 ST GOBAIN PERFORMANCE PLASTICS CORP SANI-TECH STHT-C AS MANUFACTURED IN TAUNTON MA
23968 A II 7/9/2010 CALYX CHEMICALS AND PHARMACEUTICALS
LTD
ARTEMETHER AS MANUFACTURED IN MAHARASHTRA INDIA
23969 A III 7/1/2010 HMC POLYMERS CO LTD PURELL RP271G AS MANUFACTURED IN RAYONG THAILAND
23970 A IV 7/4/2010 TOSAF COMPOUNDS LTD EXCIPIENT, COLORANT, FLAVOR, ESSENCE, OR MATERIAL USED IN PREPARATION FOR
TOSAF COMPOUNDS AS MANUFACTURED IN KEFAR YONA ISRAEL
23971 A II 7/6/2010 CHONGQING FUAN PHARMACEUTICAL CO
LTD
AZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN
CHONGQING CHINA FOR G&A ASSOCIATES LLC
23972 A II 10/25/2010 SRI KRISHNA PHARMACEUTICALS LTD SODIUM PHENYL BUTYRATE GRANULES 100% (ESUB) AS MANUFACTURED IN
HYDERABAD INDIA
23973 A II 8/25/2010 WUHAN WUYAO PHARMACEUTICAL CO LTD ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
WUHAN, CHINA
23974 A II 7/6/2010 PORTON PHARMACEUTICAL LTD CLINDAMYCIN PALMITATE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG AS
MANUFACTURED IN CHONGQING, P.R. CHINA
23975 A II 7/15/2010 MSN LABORATORIES LTD ROSUVASTATIN CALCIUM (ROUTE CODE RT) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
23976 A III 7/13/2010 EVA FILSAKOVA VINAMET HDPE BOTTLES FOR SOLID DOSAGE FORMS AS MANUFACTURED IN MISKOVICE, CZECH
REPUBLIC
23977 A II 7/14/2010 AARTI INDUSTRIES LTD MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA
23978 A II 7/19/2010 FORMOSA LABORATORIES INC ORLISTAT AS MANUFACTURED IN TAOYUAN TAIWAN
23979 A II 7/19/2010 WUXI JIDA PHARMACEUTICAL CO LTD CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN JIANGSU PROVINCE CHINA
23980 A II 7/19/2010 RAKS PHARMA PVT LTD METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23981 A III 7/20/2010 GRUPA AZOTY S.A. TARNOFORM 300 AS MANUFACTURED IN TARNOW, POLAND
23982 A II 7/20/2010 CADILA HEALTHCARE LTD IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA
23983 A III 7/20/2010 GRUPA AZOTY S.A. TARNOFORM 500 AS MANUFACTURED IN TARNOW, POLAND
23984 A II 7/13/2010 FIS FABBRICA ITALIANA SINTETICI SPA ENTACAPONE AS MANUFACTURED IN VICENZA ITALY
23985 A II 5/22/2010 QILU PHARMACEUTICAL CO LTD CISPLATIN (NON STERILE API) AS MANUFACTURED IN JINAN SHANDONG PROVINCE
PEOPLES REPUBLIC OF CHINA
23986 A III 7/21/2010 AMERICAS STYRENICS LLC GENERAL PURPOSE POLYSTYRENE (GPPS) RESINS AS MANUFACTURED IN GALES
FERRY, CT; IRONTON, OH; CHANNAHON, IL; TORRANCE, CA AND MARIETTA, OH
23987 A III 7/23/2010 SABIC PETROCHEMICALS BV SABIC PP PCGH10 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS
23988 A III 7/23/2010 SABIC PETROCHEMICALS BV SABIC PP PCGH19 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS
23989 A III 7/23/2010 SABIC PETROCHEMICALS BV SABIC HDPE PCG80063 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS
23990 A II 7/23/2010 DIVIS LABORATORIES LTD 2-4-WING ACTIVE ESTER AS MANUFACTURED IN ANDHRA PRADESH INDIA
23991 A II 7/22/2010 ROVI CONTRACT MANUFACTURING SL STERILE WATER FOR INJECTION USP 2.0 ML AS MANUFACTURED IN MADRID SPAIN
Page 713
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23992 A II 7/22/2010 ROVI CONTRACT MANUFACTURING SL STERILE WATER FOR INJECTION USP 0.5 ML AS MANUFACTURED IN MADRID SPAIN
23993 A II 7/26/2010 RANBAXY LABORATORIES LTD ADEFOVIR DIPIVOXIL AS MANUFACTURED IN PUNJAB, INDIA
23994 A II 7/26/2010 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)[PROCESS-2] AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
23995 A II 7/30/2010 FRESENIUS KABI ONCOLOGY LTD CARBOPLATIN (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA
23996 A II 7/26/2010 DR REDDYS LABORATORIES LTD BORTEZOMIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA
23997 A II 7/2/2010 ALP PHARM BEIJING CO LTD POLYMYXIN B SULFATE USP AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP
PHARM BEIJING CO LTD
23998 A II 7/20/2010 ALP PHARM BEIJING CO LTD CALCITONON SALMON AS MANUFACTURED IN SHANGHAI, P.R. CHINA FOR ALP PHARM
BEIJING CO LTD
23999 A II 7/2/2010 ALP PHARM BEIJING CO LTD BACITRACIN AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING CO
LTD
24000 A II 7/2/2010 ALP PHARM BEIJING CO LTD BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING
CO LTD
24001 A IV 7/27/2010 GATTEFOSSE SAS PLUROL OLEIQUE CC 497, AS MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE
24002 A II 7/22/2010 CALYX CHEMICALS AND PHARMACEUTICALS
LTD
HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
24003 A II 7/27/2010 MSN PHARMACHEM PVT LTD MOXIFLOXACIN HYDROCHLORIDE (ANHYDROUS) [ROUTE CODE: MP] AS MANUFACTURED
ANDHRA PRADESH, INDIA
24004 A II 7/28/2010 TORAY INDUSTRIES INC BPS-314d DRUG SUBSTANCE AS MANUFACTURED IN SHIZUOKA, JAPAN
24005 N NOT AN ASSIGNED NUMBER
24006 A IV 7/25/2010 VIKRAM THERMO INDIA LTD METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER DISPERSION NF (METHACRYLIC
ACID COPOLYMER DISPERSION) AS MANUFACTURED IN GUJARAT, INDIA
24007 A II 7/20/2010 CSPC CENWAY TIANJIN PHARMACEUTICALS
CO LTD
7-AVCA AS MANUFACTURED IN TIANJIN P.R. CHINA
24008 A III 7/29/2010 TORAY INDUSTRIES INC NYLON 6/66 RESIN T-1200P AS MANUFACTURED IN NAGOYA, JAPAN
24009 A II 7/29/2010 MYLAN LABORATORIES LTD EPROSARTAN MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24010 A IV 7/27/2010 LONZA INC GLYCOMUL TS KFG AS MANUFACTURED IN WILLIAMSPORT, PA
24011 A IV 7/27/2010 HENKEL CORP DURO-TAK (TM) 87-905A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN
SALISBURY, NC
24012 P *** PENDING FILING REVIEW ***
24013 A II 7/30/2010 ATON PHARMA INC PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR ATON PHARMA
INC
24014 A II 7/23/2010 3D IMAGING LLC [I-124] FIAU (FIALURIDINE) AS MANUFACTURED IN LITTLE ROCK, AR
24015 A II 7/23/2010 SYMBIOTICA SPECIALITY INGREDIENTS SDN
BHD
CLOBETASOL PROPIONATE AS MANUFACTURED IN KEDAH, MALAYSIA
24016 A II 8/23/2010 ALKEM LABORATORIES LTD OLANZAPINE USP (ESUB) AS MANUFACTURED IN A P INDIA FOR ALKEM LABORATORIES
LIMITED
24017 A II 7/26/2010 CALYX CHEMICALS AND PHARMACEUTICALS
LTD
IRBESARTAN AS MANUFACTURED IN MAHARASHTRA, INDIA
24018 A II 8/2/2010 MYLAN LABORATORIES LTD CLINDAMYCIN PALMITATE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24019 A II 8/2/2010 YANTAI VALIANT FINE CHEMICAL CO LTD 1, 4-DIOXASPIRO[4.5]DECAN-8-ONE AS MANUFACTURED IN SHANDONG, P.R. CHINA
Page 714
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24020 A II 8/11/2010 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
OLANZAPINE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
24021 A II 7/20/2010 PRODUCTOS QUIMICOS NATURALES SA DE
CV
DANAZOL AS MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO
24022 A II 8/4/2010 NEULAND LABORATORIES LTD MIRTAZAPINE, USP (ANHYDROUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24023 A II 6/28/2010 KUKDONG OIL AND CHEMICAL CO LTD WHITE MINERAL OIL LILY-50 AS MANUFACTURED IN KYUNGNAM, KOREA
24024 A II 8/10/2010 UNIQUE CHEMICALS ATENOLOL USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24025 A III 7/30/2010 SARONG POLYVINYLCHLORIDE/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN
REGGIOLO (R.E.), ITALY
24026 A II 8/2/2010 MOEHS IBERICA SL SUMATRIPTAN AS MANUFACTURED IN RUBI (BARCELONA), SPAIN
24027 A II 8/5/2010 KREATIVE ORGANICS P LTD CHOLINE MAGNESIUM TRISALICYLATE POWDER AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24028 A II 8/5/2010 SEQUENT SCIENTIFIC LTD ARTESUNATE AS MANUFACTURED IN KARNATAKA, INDIA
24029 A III 7/20/2010 STARPLASTIC INDUSTRY CO LTD HIGHSTAR PF SERIES AS MANUFACTURED IN HYOGO JAPAN AND HIROSHIMA JAPAN
FOR STARPLASTIC INDUSTRY CO LTD
24030 I II 8/4/2010 EMCURE PHARMACEUTICALS LTD RITONAVIR USP AS MANUFACTURED IN MAHARASHTRA INDIA
24031 A II 8/5/2010 APOTEX PHARMACHEM INC WARFARIN POTASSIUM ISOPROPANOL SOLVATE AS MANUFACTURED IN ONTARIO
CANADA
24032 A II 8/4/2010 DERIVADOS QUIMICOS SA FINE CHEMICALS FENOFIBRATE AS MANUFACTURED IN MURCIA SPAIN
24033 I II 7/14/2010 ALP PHARM BEIJING CO LTD CISATRACURIUM BESYLATE AS MANUFACTURED IN SHAANXI PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD
24034 N NOT AN ASSIGNED NUMBER
24035 A II 7/26/2010 ALP PHARM BEIJING CO LTD ALVIMOPAN DIHYDRATE AS MANUFACTURED IN CHONGQING CHINA FOR ALP PHARM
BEIJING CO LTD
24036 A II 7/31/2010 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
QUETIAPINE FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24037 A IV 8/2/2010 CATALENT PHARMA SOLUTIONS LLC GELATIN MASSES AS MANUFACTURED IN SOMERSET, NJ
24038 A II 7/30/2010 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
METOPROLOL TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24039 A III 7/16/2010 SHAKAI PACKAGING PVT LTD ALUMINIUM SEALS AS MANUFACTURED IN NANI DAMAN, INDIA
24040 A II 7/25/2010 MELODY HEALTHCARE PVT LTD SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA, INDIA
24041 N NOT AN ASSIGNED NUMBER
24042 A III 7/31/2010 COGENT GLASS LTD TUBULAR GLASS VIALS USP TYPE-I AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24043 A III 9/23/2010 AERO PUMP GMBH METERED DOSE SYSTEMS (ESUB) AS MANUFACTURED IN HOCHHEIM GERMANY
24044 A II 8/5/2010 PHARMACEUTICAL WORKS POLPHARMA SA SOLIFENACIN SUCCINATE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
24045 A III 7/30/2010 FRESENIUS KABI NORGE AS OVALIA POLYPROPYLEN AMPOULES AS MANUFACTURED IN FELUY, BELGIUM FOR
FRESENIUS KABI NORGE AS
24046 A II 8/2/2010 PFANSTIEHL INC D-RIBOSE, HIGH PURITY (LOW ENDOTOXIN) (R-104-1) AS MANUFACTURED IN WAUKEGAN,
IL
24047 A II 8/6/2010 PARABOLIC DRUGS LTD CEFPROZIL USP AS MANUFACTURED IN PUNJAB, INDIA
24048 A II 7/8/2010 JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP
AMPHETAMINE SULFATE, USP (PROCESS II) AS MANUFACTURED IN WEST DEPTFORD, NJ
24049 A II 8/2/2010 JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP
SODIUM OXYBATE AS MANUFACTURED IN WEST DEPTFORD, NJ
24050 A II 8/9/2010 MAHENDRA CHEMICALS LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA
Page 715
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24051 A II 8/9/2010 MAHENDRA CHEMICALS LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA
24052 A II 11/4/2010 JUBILANT LIFE SCIENCES LTD TELMISARTAN (ESUB) AS MANUFACTURED IN NANJANGUD MYSORE DIST INDIA
24053 P *** PENDING FILING REVIEW ***
24054 A II 11/4/2010 JUBILANT LIFE SCIENCES LTD RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED NANJANGUD MYSORE DIST INDIA
24055 A III 8/11/2010 WINPAK FILMS INC PUREFLEX FILM AS MANUFACTURED IN SENOIA, GA
24056 A II 8/3/2010 KONDUSKAR LABORATORIES PVT LTD LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24057 A III 8/5/2010 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK(TM) 9753 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
24058 A III 8/5/2010 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK(TM) 9754 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
24059 A III 8/5/2010 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK(TM) 9756 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
24060 A III 8/5/2010 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK(TM) 9757 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND
GREENVILLE, SC
24061 A II 8/12/2010 APOTEX PHARMACHEM INDIA PVT LTD RIZATRIPTAN BENZOATE AS MANUFACTURED IN KARNATAKA, INDIA
24062 I III 8/10/2010 BRIGHTWOOD PHARMMED CONSUMABLE BEIJING LTD 3 LAYER CO-EXTRUSION POLYPROPYLENE IV INFUSION FILM AS MANUFACTURED IN TONGZHOU INDUSTRY DISTRICT BEIJING, P.R. CHINA
24063 A II 7/19/2010 VITAL HEALTH CARE PVT LTD QUININE SULFATE USP AS MANUFACTURED IN GUJARAT, INDIA
24064 A III 7/21/2010 GERRESHEIMER PLASTICOS SAO PAULO
LTDA
DOSAGE CUPS, ORAL SYRINGES, DROPPERS, PIPETTES AND ACCESSORIES FOR
PACKAGING AS MANUFACTURED IN EMBU SP, BRASIL
24065 A IV 8/15/2010 CRODA INC CRODALAN AWS AS MANUFACTURED IN MILL HALL, PA
24066 A II 8/10/2010 SPECTRON MRC LLC GALLIUM GA68 ALBUMIN AGGREGATED ([68GA]MAA) AS MANUFACTURED IN SOUTH
BEND, IN
24067 A II 8/16/2010 MYLAN LABORATORIES LTD SITAGLIPTIN PHOSPHATE AS MANUFACTURED ANDHRA PRADESH, INDIA
24068 A III 9/27/2010 ECLATIN AG INTERNAL PROTECTIVE LACQUER A-2079 AS MANUFACTURED IN SOLOTHURN,
SWITZERLAND
24069 A II 1/12/2011 ARCH PHARMALABS LTD ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4-
ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24070 A II 9/13/2010 ARCH PHARMALABS LTD (DKT -III) 4-FLUORO- ALPHA- [2-METHYL-1 -OXO- PROPYL]-Y-OXO-N-BETA- DIPHENYL
BENZENE BUTANAMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24071 A II 8/10/2010 JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP
DEXTROAMPHETAMINE SACCHARATE (PROCESS2) AS MANUFACTURED IN WEST
DEPTFORD, NJ
24072 A II 8/16/2010 JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP
AMPHETAMINE ASPARTATE (PROCESS2) AS MANUFACTURED IN WEST DEPTFORD, NJ
24073 A II 6/30/2010 PIERRE FABRE MEDICAMENT-PLANTES &
INDUSTRIE
MILNACIPRAN HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN CELRA (GIRONA),
SPAIN FOR PIERRE FABRE MEDICAMENT-PLANTES & INDUSTRIE
24074 A III 8/9/2010 INGENIA POLYMERS CORP INGENIA POLYMERS IT-982 FILLED WHITE AS MANUFACTURED IN ONTARIO, CANADA,
ALBERTA, CANADA AND HOUSTON, TEXAS
24075 A III 8/18/2010 PPG INDUSTRIES INC PPG9145-403 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
24076 A III 8/18/2010 PPG INDUSTRIES INC PPG2803-302 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
24077 A IV 8/18/2010 FONA INTERNATIONAL INC 862.0249U N-C LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
24078 A III 8/18/2010 PFP TERMOPOLIMEROS SL HDPE/BO-TE FAB CONTAINER AS MANUFACTURED IN BARCELONA, SPAIN
24079 A IV 8/13/2010 AVANTOR PERFORMANCE MATERIALS INC PANEXCEA(TM) MC200G (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR
AVANTOR PERFORMANCE MATERIALS INC
24080 A II 8/16/2010 3M DRUG DELIVERY SYSTEMS RESIQUIMOD DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS CODEX, FRANCE
Page 716
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24081 A III 8/13/2010 LONSTROFF AG RUBBER COMPOUNDS AS MANUFACTURED IN AARAU, SWITZERLAND
24082 A II 8/17/2010 PERRIGO API LTD DONEPEZIL HYDROCHLORIDE FORM III AS MANUFACTURED IN BE'ER SHEVA, ISRAEL
24083 A II 8/18/2010 TRIAD ISOTOPES INC FLUORINE-18 SODIUM FLUORIDE AS MANUFACTURED IN CHARLESTON, SC AND
NORCROSS, GA
24084 A II 8/14/2010 SHANGHAI ZIYUAN PHARMACEUTICAL CO
LTD
CHLOROTHIAZIDE USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN SHANGHAI,
P.R. CHINA
24085 A II 8/16/2010 BEIJING KEYIFENG BIOTECH DEVELOPMENT
CO LTD
ESTRADIOL USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN BEIJING, P.R. CHINA
24086 A II 8/31/2010 AUROBINDO PHARMA LTD RIVASTIGMINE TARTRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH INDIA
24087 A II 8/18/2010 HIKAL LTD QUETIAPINE FUMARATE API AS MANUFACTURED IN BANGALORE, INDIA
24088 A V 8/20/2010 CARDINAL HEALTH 414 LLC POSITRON EMISSION TOMOGRAPHY (PET) FACILITIES AS LOCATED IN CHARLOTTE, NC;
COLTON, CA; COLUMBUS, OH; EAST HARTFORD, CT; FORT LAUDERDALE, FL; ORLANDO,
FL; PHOENIX, AZ
24089 A III 6/18/2010 WINPAK HEAT SEAL PACKAGING INC FLEXIBLE PACKAGING MATERIALS FOR POUCH/SACHET PACKAGING AS
MANUFACTURED IN QUEBEC, CANADA
24090 A II 8/23/2010 MSN PHARMACHEM PVT LTD ARIPIPRAZOLE [ROUTE CODE: AL1] AS MANUFACTURED IN ANDHRA PRADESH INDIA
24091 A II 8/20/2010 PHARMATHEN INDUSTRIAL SA FLUVASTATIN SODIUM AMORPHOUS AS MANUFACTURED IN GUJARAT, INDIA FOR
PHARMATHEN INDUSTRIAL SA
24092 A IV 8/16/2010 3M DRUG DELIVERY SYSTEMS SOLVATED ACRYLATE COPOLYMER ADHESIVE R-27171 AS MANUFACTURED IN
CORDOVA, IL
24093 A II 8/17/2010 3M DRUG DELIVERY SYSTEMS RESIQUIMOD TOPICAL GEL AS MANUFACTURED IN ST. PAUL, MN
24094 A IV 8/23/2010 DAVID MICHAEL AND CO INC MICHAELOK NATURAL LEMON FLAVOR #676 AS MANUFACTURED IN PHILADELPHIA, PA
24095 A III 8/2/2010 STELLA KUNSTSTOFFTECHNIK GMBH STELLA SCREW-NECK BOTTLE SECRO PP28 AND STELLA PROTECAP PP28 AS
MANUFACTURED IN SUCY-EN-BRIE, FRANCE AND ELTVILLE, GERMANY FOR STELLA
KUNSTSTOFFTECHNIK GMBH
24096 A II 8/12/2010 CTX LIFE SCIENCES PVT LTD CARVEDILOL (ROUTE-II) AS MANUFACTURED IN GUJARAT, INDIA
24097 A III 8/24/2010 ASSEM PAK INC ELASTOMERIC STOPPERS AND CLOSURES AS MANUFACTURED IN VINELAND, NJ
24098 A II 9/2/2010 UNICHEM LABORATORIES LTD ARIPIPRAZOLE USP (ESUB) AS MANUFACTURED IN ROHA DIST RAIGAD INDIA
24099 A IV 8/27/2010 SPI PHARMA INC PHARMABURST 500 AND SL SERIES PRODUCTS AS MANUFACTURED IN GRAND HAVEN,
MI
24100 A II 8/26/2010 NUTRA SPECIALITIES PRIVATE LTD TETRACAINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24101 A III 8/24/2010 CONSOLIDATED BOTTLE CORP ? INCH X 2 INCH NATURAL PP VIAL PRINTED WITH LINE AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
24102 A III 8/24/2010 CONSOLIDATED BOTTLE CORP 1 INCH WHITE SMOOTH TOP PE CAP PLUG FINISH AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
24103 A III 8/24/2010 CONSOLIDATED BOTTLE CORP 1 INCH X 2 INCH NATURAL PP VIAL PRINTED WITH LINE AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
24104 A III 8/24/2010 CONSOLIDATED BOTTLE CORP ? INCH WHITE SMOOTH TOP PE CAP PLUG FINISH AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
24105 A III 7/21/2010 BESPAK DIV CONSORT MEDICAL PLC BK357 & BK361 VALVE EXTRACTABLES INFORMATION AS MANUFACTURED IN NORFOLK,
ENGLAND
24106 A II 8/27/2010 INDOCO REMEDIES LTD OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA
24107 A II 8/31/2010 DIPHARMA FRANCIS SRL GLYCERYL TRINITRATE SOLUTION AS MANUFACTURED IN MERETO DI TOMBA (UD), ITALY
Page 717
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24108 A II 8/31/2010 DAIWA PHARMACEUTICAL CO LTD LOXOPROFEN SODIUM HYDRATE AS MANUFACTURED IN TOYAMA, JAPAN
24109 A III 8/20/2010 APTAR FRANCE SAS APTAR UNIT DOSE AND BIDOSE SYSTEMS AS MANUFACTURED IN CONGERS, NY AND
EIGELTINGEN, GERMANY AND LE VAUDREUIL, FRANCE
24110 A II 8/30/2010 MACLEODS PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN GUJARAT, INDIA
24111 A IV 8/25/2010 ABELEI INC 113a61 NATURAL & ARTIFICIAL BERRY TYPE FLAVOR AS MANUFACTURED IN NORTH
AURORA, IL
24112 A II 8/31/2010 PHARMAZELL DENMARK AS TERBINAFINE AS TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN HVIDOVRE,
DENMARK
24113 A III 8/31/2010 HB FULLER CO ADHESIVE USED IN PLASTIC CLOSURE SYSTEMS AS MANUFACTURED IN JACKSON, TN
24114 A II 8/30/2010 GULBRANDSEN TECHNOLOGIES INC ACHIEVE L 5440 PG SOLUTION AS MANUFACTURED IN PHILLIPSBURG, NJ
24115 I III 6/21/2010 PLASTIAPE SPA DESICCANT CAP AND PILL JAR AS MANUFACTURED IN LECCO, ITALY
24116 A II 9/27/2010 AUROBINDO PHARMA LTD ATORVASTATIN CALCIUM (AMORPHOUS) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH INDIA
24117 A II 11/12/2010 XOMA US LLC XOMA 3AB (ESUB) AS MANUFACTURED IN BERKELEY CA
24118 A II 9/1/2010 ZHEJIANG JINHUA CONBA BIO PHARM CO
LTD
OMEPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24119 A II 12/28/2010 IPCA LABORATORIES LTD ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN DISTRICT RATLAM (MADHYA
PRADESH), INDIA
24120 I II 12/9/2010 IPCA LABORATORIES LTD BISOPROLOL FUMARATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA
24121 A II 12/15/2010 IPCA LABORATORIES LTD CITALOPRAM HYDROBROMIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH
INDIA
24122 A IV 8/30/2010 PFANSTIEHL INC ALPHA, ALPHA-TREHALOSE DIHYDRATE, HIGH PURITY (LOW ENDOTOXIN), USP/NF, EP (T-
104-4) AS MANUFACTURED IN WAUKEGAN, IL
24123 A II 9/1/2010 CATALENT PHARMA SOLUTIONS LLC VEGICAPS SOFT SHELL GEL MASS FORMULATION AS MANUFACTURED IN ST.
PETERSBURG, FL
24124 A II 9/9/2010 GLENMARK GENERICS LTD BOSENTAN (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24125 A V 8/25/2010 JANSSEN DIAGNOSTICS BVBA GENOTYPIC RESISTANCE TESTING FOR HCV AS LOCATED IN BEERSE, BELGIUM
24126 A II 8/31/2010 SCINOPHARM TAIWAN LTD CAPECITABINE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN, ROC
24127 A II 9/3/2010 IRVINE SCIENTIFIC SALES CO FMDF-11 (KIRIN) AS MANUFACTURED IN SANTA ANA CA
24128 A II 8/31/2010 RPG LIFE SCIENCES LTD DOXORUBICIN HYDROCHLORIDE USP/EP AS MANUFACTURED IN ANKLESHWAR
BHARUCH INDIA
24129 A II 9/2/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD MYCOPHENOLATE SODIUM AS MANUFACTURED IN DEBRECEN HUNGARY FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
24130 A II 8/30/2010 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
CLOPIDOGREL BISULFATE AS MANUFACTURED IN ZHEJIANG CHINA
24131 A III 10/18/2010 HOSPIRA INC ABBOJECT VIAL INJECTOR (ESUB) AS MANUFACTURED IN ROCKY MOUNT NC
24132 A III 8/30/2010 AMPACET CORP 103177 SLIP PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
24133 A II 8/19/2010 QILU PHARMACEUTICAL CO LTD IRINOTECAN HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE PEOPLES REPUBLIC OF CHINA
24134 A II 8/31/2010 NECTAR LIFESCIENCES LTD CEFTRIAXONE SODIUM (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN
CHANDIGARH INDIA
24135 A II 8/16/2010 VITAL LABORATORIES PVT LTD DIGOXIN AS MANUFACTURED IN GUJARAT INDIA
Page 718
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24136 A II 3/4/2011 SHILPA MEDICARE LTD GEMCITABINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
24137 A III 9/3/2010 RELIANCE INDUSTRIES LTD RELENE 1070LA17 AS MANUFACTURED IN MAHARASHTRA, INDIA
24138 A IV 9/6/2010 LIPOID GMBH LIPOID E 100, LIPOID E PC S, LIPOID E PC AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
24139 A II 9/7/2010 RANBAXY LABORATORIES LTD ATORVASTATIN CALCIUM, USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA
24140 A III 6/8/2010 ROHM AND HAAS CO PARALOID RESINS USED AS A COMPONENT IN PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN LOUISVILLE, KY
24141 A IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
5X00195 LUBRITOSE SD AS MANUFACTURED IN NORWICH, NY
24142 A IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
5X00217 LUBRITOSE MCC AS MANUFACTURED IN NORWICH, NY
24143 I IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
5X00255 SHEFFCOAT CLEAR GL AS MANUFACTURED IN NORWICH, NY
24144 I IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
5X00282 SHEFFCOAT CLEAR 02 AS MANUFACTURED IN NORWICH, NY
24145 I II 9/23/2010 USV LIMITED DOLASETRON MESYLATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
24146 A III 6/23/2010 FUJIMORI KOGYO CO LTD PLASTIC FILMS FOR USE IN DRUG PRODUCT CONTAINER AS MANUFACTURED IN NABARI-
CITY, JAPAN
24147 A II 7/27/2010 MICRON TECHNOLOGIES INC MICRONIZATION PROCESS FACILITY AS LOCATED IN MALVERN, PA
24148 A II 9/9/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN ZAGREB, CROATIA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
24149 A IV 8/13/2010 DOW CORNING CORP DOW CORNING SILMOGEN CARRIER AS MANUFACTURED IN HEMLOCK, MI
24150 A IV 8/13/2010 DOW CORNING CORP DOW CORNING? DIMETHICONOL BLEND 20 AS MANUFACTURED IN HEMLOCK, MI
24151 A II 8/28/2010 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
ADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE) AS MANUFACTURED IN ZHEJIANG
PROVINCE PR CHINA
24152 A II 8/1/2010 SERATEC METHYLDOPATE HYDROCHLORIDE USP AS MANUFACTURED IN EURE ET LOIR FRANCE
24153 A II 9/10/2010 MACLEODS PHARMACEUTICALS LTD RIVASTIGMINE TARTRATE AS MANUFACTURED IN GUJARAT INDIA
24154 A II 9/10/2010 INTERQUIM SA SOLIFENACIN SUCCINATE AS MANUFACTURED IN BARCELONA SPAIN
24155 A II 9/9/2010 ALKALOIDS CORP COLCHICINE USP (REFINED GRADE) AS MANUFACTURED IN ANDHRA PRADESH INDIA
FOR ALKALOIDS CORPORATION
24156 A V 11/24/2010 XOMA US LLC NONCLINICAL (PHARMACOLOGY, PHARMACOKINETICS, AND TOXICOLOGY) (ESUB) FOR
XOMA 3AB LOCATED IN BERKELEY CA
24157 A II 1/27/2011 MALLINCKRODT INC NOSCAPINE USP/EP CRYSTALS CODE 6047 (ESUB) AS MANUFACTURED IN ST LOUIS MO
24158 A III 3/29/2011 SCHOTT NORTH AMERICA INC FORMA 3S PREFILLABLE GLASS SYRINGES (ESUB) AS MANUFACTURED IN LEBANON,
PA AND QUEENSBURY, NY FOR SCHOTT NORTH AMERICA INC
24159 A II 9/1/2010 TAI HENG INDUSTRY CO LTD RASAGILINE MESYLATE AS MANUFACTURED IN SHANGHAI PR CHINA
24160 A II 8/31/2010 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
CEFTRIAXONE SODIUM (NON-STERILE) AS MANUFACTURED IN HEBEI PROVINCE PR
CHINA
24161 A II 8/29/2010 PERRIGO API LTD LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA ISRAEL
24162 A II 9/7/2010 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
HEXETIDINE AS MANUFACTURED IN GUJARAT INDIA
24163 A II 9/24/2010 GLENMARK GENERICS LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
Page 719
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24164 A III 8/19/2010 ALPHAPOINTE ASSN FOR THE BLIND POLYPROPYLENE PLASTIC BOTTLES USED FOR ORAL MEDICATION AS MANUFACTURED
IN KANSAS CITY, MO
24165 A III 8/19/2010 ALPHAPOINTE ASSN FOR THE BLIND HIGH DENSITY POLYETHYLENE PLASTIC BOTTLES USED FOR ORAL MEDICATION AS
MANUFACTURED IN KANSAS CITY, MO
24166 A IV 9/10/2010 UNGERER AND CO NATURAL MELON WONF FLAVOR #14747 AS MANUFACTURED IN BETHLEHEM, PA
24167 A III 9/14/2010 PPG INDUSTRIES INC PPG PACKAGING AND
COATINGS
PPG4553-603 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
24168 A II 9/15/2010 3D IMAGING DRUG DESIGN AND
DEVELOPMENT LLC
[F-18] FDPN AS MANUFACTURED IN LITTLE ROCK, ARKANSAS
24169 A III 9/14/2010 PPG INDUSTRIES INC PPG PACKAGING AND
COATINGS
P-2238862 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
24170 A III 9/14/2010 PPG INDUSTRIES INC PPG PACKAGING AND
COATINGS
PPG4553-303 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH
24171 A III 9/10/2010 HUDSON COLOR CONCENTRATES WHITE HC81523PVC AS MANUFACTURED IN LEOMINSTER, MA
24172 A III 9/14/2010 AMERICAS STYRENICS LLC HIGH IMPACT POLYSTYRENE (HIPS) RESINS AS MANUFACTURED IN GALES FERRY, CT;
IRONTON, OH; CHANNAHON, IL; TORRANCE, CA AND MARIETTA, OH
24173 A II 8/6/2010 GLOPEC INTERNATIONAL INC TEMOZOLOMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR GLOPEC
INTERNATIONAL INC
24174 A II 8/7/2010 SMRUTHI ORGANICS LTD S (-) AMLODIPINE BESILATE USP AS MANUFACTURED IN MAHARASHTRA, INDA
24175 A II 9/13/2010 JIANGSU HENGRUI MEDICINE CO LTD DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN JIANGSU, P.R. CHINA
24176 A II 10/6/2010 ZHEJIANG XIANJU JUNYE PHARMACEUTICAL
CO LTD
NORETHINDRONE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES
REPUBLIC OF CHINA
24177 A II 9/27/2010 UNIMARK REMEDIES LTD RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24178 A II 9/13/2010 MACLEODS PHARMACEUTICALS LTD VALSARTAN USP AS MANUFACTURED IN GUJARAT, INDIA
24179 A II 9/14/2010 SHASUN PHARMACEUTICALS LTD KETOPROFEN AS MANUFACTURED IN CUDDALORE, INDIA
24180 A II 9/29/2010 TORRENT PHARMACEUTICALS LTD OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24181 A II 9/15/2010 MSN ORGANICS PVT LTD PIOGLITAZONE HYDROCHLORIDE [ROUTE CODE: PG] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24182 I II 9/15/2010 ELAN DRUG DELIVERY INC N1766 TABLETS AS MANUFACTURED IN KING PRUSSIA, PA
24183 A II 9/15/2010 DIVIS LABORATORIES LTD TRITYL LOSARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24184 A II 9/13/2010 POLYDRUG LABORATORIES PVT LTD FERROUS FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA
24185 A II 9/17/2010 CHONGQING DAXIN PHARMACEUTICAL CO
LTD
VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, P.R. CHINA
24186 A II 9/10/2010 MEGAFINE PHARMA P LTD SOLIFENACIN SUCCINATE AS MANUFACTURED IN NASHIK, INDIA
24187 A IV 9/16/2010 HENKEL CORP DURO-TAK(TM) 87-624A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN
SALISBURY, NC
24188 A II 9/27/2010 AUROBINDO PHARMA LTD ENTACAPONE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH INDIA
24189 A II 9/20/2010 FORMOSA LABORATORIES INC ERGOCALCIFEROL AS MANUFACTURED IN TAOYUAN, TAIWAN
24190 A III 11/9/2010 AERO PUMP GMBH PUMP SYSTEMS FOR ORAL AND TOPIC APPLICATIONS (ESUB) AS MANUFACTURED IN
HOCHHEIM GERMANY
24191 A II 9/16/2010 ESSENTIAL INGREDIENTS CUROXYL BP 42 USP AS MANUFACTURED IN POMPANO BEACH, FL FOR ESSENTIAL
INGREDENTS
Page 720
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24192 A II 10/6/2010 ZHEJIANG XIANJU JUNYE PHARMACEUTICAL
CO LTD
ESTRADIOL (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLE'S REPUBLIC OF
CHINA
24193 A II 9/20/2010 RELIABLE BIOPHARMACEUTICAL CORP CYANOMETHYL MANNOSYL ACETATE AS MANUFACTURED IN ST. LOUIS, MO
24194 A II 9/20/2010 KINGLAND CHEMICALS CO LTD BENZONATATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
24195 A II 9/17/2010 CTX LIFE SCIENCES PVT LTD CARBAMAZEPINE USP AS MANUFACTURED IN GUJARAT, INDIA
24196 A II 9/21/2010 LABORATORIO CHIMICO INTERNAZIONALE
SPA
PREGABALIN AS MANUFACTURED IN SEGRATE MI, ITALY
24197 A II 9/21/2010 NATIONAL JEWISH HEALTH FBC-0007 (Mn-Te-2PyP) AS MANUFACTURED IN CONCORD, OH FOR NATIONAL JEWISH
HEALTH
24198 A II 9/21/2010 ACS DOBFAR SPA GENTAMICIN SULFATE AS MANUFACTURED IN BERGAMO, ITALY
24199 A II 10/9/2010 SUN PHARMACEUTICAL INDUSTRIES LTD SITAGLIPTIN PHOSPHATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24200 A II 10/28/2010 JUBILANT LIFE SCIENCES LTD LEVETIRACETAM (ESUB) AS MANUFACTURED IN NANJANGUD MYSORE DIST INDIA
24201 I II 9/25/2010 QILU PHARMACEUTICAL CO LTD CARBOPLATIN PROCESS II AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES
REPUBLIC OF CHINA
24202 A II 12/15/2011 CHEM WERTH INC DEXMEDETOMIDINE HCL (ESUB) AS MANUFACTURED IN NEWBURYPORT MA
24203 A II 8/26/2010 HAINAN POLY PHARMACEUTICAL CO LTD TRIMEBUTINE MALEATE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, P.R.
CHINA
24204 A III 9/23/2010 SK CHEMICALS CO LTD SKYPET BR AS MANUFACTURED IN ULSAN, KOREA
24205 A II 9/22/2010 INFA SA MELOXICAM AS MANUFACTURED IN MURCIA, SPAIN FOR INFA S.A.
24206 A II 9/28/2010 SMS PHARMACEUTICALS LTD TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24207 A II 3/4/2011 RELIANCE LIFE SCIENCES PVT LTD IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
24208 A II 9/28/2010 MYLAN LABORATORIES LTD LATANOPROST AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24209 A II 10/28/2010 GLENMARK GENERICS LTD DEFERASIROX (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24210 A II 9/24/2010 JIANGXI SYNERGY PHARMACEUTICAL CO
LTD
ACECLOFENAC AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA
24211 A II 9/24/2010 JIANGXI SYNERGY PHARMACEUTICAL CO
LTD
TELMISARTAN AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA
24212 A IV 9/24/2010 HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL BUTTERSCOTCH FLAVOR CONCENTRATE #5659 AS MANUFACTURED IN
PHILADELPHIA, PA
24213 A II 9/30/2010 CEDARBURG PHARMACEUTICALS INC BRIMONIDINE TARTRATE AS MANUFACTURED IN GRAFTON, WI
24214 A III 9/27/2010 FLEXTRUS AB TRANSOFOIL EL-OPET/I AS MANUFACTURED IN LUND, SWEDEN
24215 A II 9/22/2010 SYMBIOTICA SPECIALITY INGREDIENTS SDN
BHD
DEXAMETHASONE SODIUM PHOSPHATE AS MANUFACTURED IN KEDAH, MALAYSIA
24216 A II 9/17/2010 PRODUCTOS QUIMICOS NATURALES SA DE
CV PROQUINA
PRASTERONE (DEHYDROEPIANDROSTERONE) AS MANUFACTURED IN IXTACZOQUITLAN
VER. MEXICO
24217 A III 9/30/2010 BAXTER HEALTHCARE CORP CLARITY CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN JAYUYA, PUERTO RICO
24218 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-LIGHT BLUE PP52176043 AS MANUFACTURED IN MALMO, SWEDEN
24219 A III 9/17/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-WHITE PP00176011 AS MANUFACTURED IN MALMO, SWEDEN
24220 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-MID GREY PP72176017 AS MANUFACTURED IN MALMO, SWEDEN
Page 721
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24221 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BROWN PP83176012 AS MANUFACTURED IN MALMO, SWEDEN
24222 A III 9/17/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-RED PP33176028 AS MANUFACTURED IN MALMO, SWEDEN
24223 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-ORANGE PE23176044 AS MANUFACTURED IN MALMO, SWEDEN
24224 A III 9/17/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BLACK PP94176008 AS MANUFACTURED IN MALMO SWEDEN
24225 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BEIGE PE82176048 AS MANUFACTURED IN MALMO SWEDEN
24226 A III 9/21/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BLUISH GREEN PE63176126 AS MANUFACTURED IN MALMO SWEDEN
24227 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BROWN PE83176049 AS MANUFACTURED IN MALMO SWEDEN
24228 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-DARK BLUE PE54176153 AS MANUFACTURED IN MALMO SWEDEN
24229 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-DARK BLUE PP54176045 AS MANUFACTURED IN MALMO SWEDEN
24230 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-LIGHT BLUE PE52176155 AS MANUFACTURED IN MALMO SWEDEN
24231 A III 9/21/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-LIGHT GREEN PE62176128 AS MANUFACTURED IN MALMO SWEDEN
24232 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-MID BLUE PE52176154 AS MANUFACTURED IN MALMO SWEDEN
24233 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-MID BLUE PP52176044 AS MANUFACTURED IN MALMO SWEDEN
24234 A III 9/21/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-MID GREEN PE64176127 AS MANUFACTURED IN MALMO SWEDEN
24235 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-MID GREEN PP64176028 AS MANUFACTURED IN MALMO SWEDEN
24236 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-RED PE33176131 AS MANUFACTURED IN MALMO SWEDEN
24237 A III 9/21/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-VIOLET PE43176023 AS MANUFACTURED IN MALMO SWEDEN
24238 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-MID GREY PE72176067 AS MANUFACTURED IN MALMO, SWEDEN
24239 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-WHITE PE00176031 AS MANUFACTURED IN MALMO SWEDEN
24240 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-YELLOW PE13176076 AS MANUFACTURED IN MALMO SWEDEN
24241 A III 9/17/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-YELLOW PP13176012 AS MANUFACTURED IN MALMO SWEDEN
24242 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-DARK GREY PE74176066 AS MANUFACTURED IN MALMO, SWEDEN
24243 A III 9/17/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-PINK PP32176027 AS MANUFACTURED IN MALMO, SWEDEN
24244 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-VIOLET PP43176005 AS MANUFACTURED IN MALMO, SWEDEN
24245 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BLUISH GREEN PP63176029 AS MANUFACTURED IN MALMO, SWEDEN
24246 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BEIGE PP82176011 AS MANUFACTURED IN MALMO, SWEDEN
24247 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BLACK PL94176008 AS MANUFACTURED IN MALMO, SWEDEN
24248 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-DARK GREY PP74176018 AS MANUFACTURED IN MALMO, SWEDEN
24249 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-LIGHT GREEN PP62176027 AS MANUFACTURED IN MALMO, SWEDEN
24250 A III 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-PINK PE32176130 AS MANUFACTURED IN MALMO, SWEDEN
24251 A III 9/17/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-ORANGE PP23176008 AS MANUFACTURED IN MALMO, SWEDEN
24252 A III 9/22/2010 HRJ SURGICALS PLASTIC ITEMS USED AS PRIMARY PACKAGING MATERIAL IN PHARMACEUTICAL
PRODUCTS AS MANUFACTURED IN MAHARASHTRA, INDIA
24253 A II 9/24/2010 GULBRANDSEN TECHNOLOGIES INC ACHIEVE L 5440 PG SOLUTION AS MANUFACTURED IN GUJARAT, INDIA
24254 A II 8/25/2010 LABORATORIO OPOTERAPICO ARGENTINO
SA
CHONDROITIN SULFATE POWDER AS MANUFACTURED IN BUENOS AIRES, ARGENTINA
24255 A II 9/10/2010 ALP PHARM BEIJING CO LTD CICLESONIDE AS MANUFACTURED IN TIANJIN, P.R. CHINA FOR ALP PHARM BEIJING CO
LTD
24256 A II 9/10/2010 ALP PHARM BEIJING CO LTD MESALAMINE AS MANUFACTURED IN HEILONGJIANG, P.R. CHINA FOR ALP PHARM
BEIJING CO LTD
24257 A II 9/15/2010 ALP PHARM BEIJING CO LTD BIVALIRUDIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA FOR ALP PHARM BEIJING CO
LTD
24258 A III 10/1/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-TRANS RED PP3M176042 AS MANUFACTURED IN MALMO, SWEDEN
Page 722
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24259 A III 10/1/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-TRANS YELLOW PP1M176018 AS MANUFACTURED IN MALMO, SWEDEN
24260 A III 10/1/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-TRANS GREY PP7M176029 AS MANUFACTURED IN MALMO, SWEDEN
24261 A III 10/1/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-TRANS BLUE PP5M176061 AS MANUFACTURED IN MALMO, SWEDEN
24262 A III 10/1/2010 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-TRANS GREEN PP6M176048 AS MANUFACTURED IN MALMO, SWEDEN
24263 A II 10/6/2010 AMINO CHEMICALS LTD PALIPERIDONE AS MANUFACTURED IN MARSA, MALTA
24264 A II 12/2/2010 APICORE LLC LENALIDOMIDE (ESUB) AS MANUFACTURED IN SOMERSET NJ
24265 A IV 10/4/2010 PRODOTTI CHIMICI E ALIMENTARI SPA GLYCOCHOLIC ACID AS MANUFACTURED IN BASALUZZO (AL), ITALY
24266 A II 10/8/2010 APOTEX PHARMACHEM INC SITAGLIPTIN PHOSPHATE MONOHYDRATE AS MANUFACTURED IN BRANTFORD ON,
CANADA
24267 A III 9/29/2010 CODING PRODUCTS SV-17807 AS MANUFACTURED IN KALKASKA, MI
24268 A III 9/29/2010 CODING PRODUCTS SV-14207 AS MANUFACTURED IN KALKASKA, MI
24269 A III 9/29/2010 CODING PRODUCTS SV-19820 AS MANUFACTURED IN KALKASKA, MI
24270 A III 9/29/2010 CODING PRODUCTS SV-17383 AS MANUFACTURED IN KALKASKA, MI
24271 A III 8/13/2010 SARONG EMPTY SUPPOSITORY SHELLS OF POLYVINYLCHLORIDE/POLYETHYLENE FILM LAMINATE
AS MANUFACTURED IN REGGIOLO (R.E.), ITALY
24272 A II 10/13/2010 PROTEUS SA NEOSAXITOXIN AS MANUFACTURED IN SANTIAGO, CHILE
24273 N NOT AN ASSIGNED NUMBER
24274 A II 10/13/2010 CADILA HEALTHCARE LTD DULOXETINE HYDROCHLORIDE (DUB ROUTE) AS MANUFACTURED IN GUJARAT, INDIA
24275 A II 12/14/2010 TARO PHARMACEUTICAL INDUSTRIES LTD DESLORATADINE (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL
24276 I III 9/20/2010 HMC POLYMERS CO LTD PURELL RP270M AS MANUFACTURED IN RAYONG, THAILAND
24277 A II 10/14/2010 ALEMBIC PHARMACEUTICALS LTD FENOFIBRIC ACID AS MANUFACTURED IN GUJARAT, INDIA
24278 A II 10/14/2010 PHARMAESSENTIA CORP GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TAIPEI HSIENG, TAIWAN FOR
PHARMAESSENTIA COROPRATION
24279 A III 10/7/2010 APTAR FRANCE SAS LATITUDE(TM) SIDE ACTUATION DEVICE AS MANUFACTURED IN LE VAUDREUIL, FRANCE
24280 A III 9/20/2010 POLYONE CORP CC10132659BG AS MANUFACTURED IN ASSESSE, BELGIUM AND SAINT-OUEN L'AUMONE,
FRANCE
24281 A III 9/20/2010 POLYONE CORP CC10132662BG AS MANUFACTURED IN ASSESSE, BELGIUM AND LAINT-OUEN L'AUMONE,
FRANCE
24282 A III 9/20/2010 POLYONE CORP CC00017726WE AS MANUFACTURED IN ELK GROVE, IL
24283 A III 9/20/2010 POLYONE CORP CC00017835WE AS MANUFACTURED IN ELK GROVE, IL
24284 A III 9/20/2010 POLYONE CORP CC10012890WE AS MANUFACTURED IN ELK GROVE, IL
24285 A II 10/29/2010 AUROBINDO PHARMA LTD TRAMADOL HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH INDIA
24286 A II 11/8/2010 PHF SA LUBIPROSTONE (ESUB) AS MANUFACTURED IN BUENOS AIRES ARGENTINA FOR PHF SA
24287 I II 12/9/2010 PHF SA IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN RAICHUR INDIA FOR PHA SA
24288 A II 11/1/2010 USV LIMITED OCTREOTIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
24289 A II 10/15/2010 SEQUENT SCIENTIFIC LTD ACYCLOVIR SODIUM AS MANUFACTURED IN KARNATAKA, INDIA
24290 I II 10/9/2010 QILU PHARMACEUTICAL CO LTD RISPERIDONE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P.R.
CHINA
24291 A II 9/28/2010 JOHNSON MATTHEY INC MORPHINE TECHNICAL ALKALOID AS MANUFACTURED IN WEST DEPTFORD, NJ
24292 A II 9/30/2010 ALEMBIC PHARMACEUTICALS LTD PREGABALIN AS MANUFACTURED IN GUJARAT, INDIA
Page 723
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24293 A IV 10/15/2010 ABELEI INC 148A84 NATURAL AND ARTIFICIAL GRAPEFRUIT ORANGE FLAVOR AS MANUFACTURED IN
NORTH AURORA, IL
24294 A IV 10/15/2010 ABELEI INC 196A22 NATURAL AND ARTIFICIAL JUICY FRUIT TYPE FLAVOR AS MANUFACTURED IN
NORTH AURORA, IL
24295 A IV 10/15/2010 ABELEI INC 174A78 NATURAL AND ARTIFICIAL MINT FLAVOR AS MANUFACTURED IN NORTH AURORA,
IL
24296 A II 11/4/2010 AUROBINDO PHARMA LTD CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH INDIA
24297 A II 10/29/2010 IND SWIFT LABORATORIES LTD CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PUNJAB INDIA
24298 A II 12/17/2010 IND SWIFT LABORATORIES LTD TEMOZOLOMIDE (ESUB) AS MANUFACTURED IN PUNJAB INDIA
24299 A III 10/8/2010 TEKNOR COLOR CO 32,820HCC AMBER 50:1 AS MANUFACTURED IN JACKSONVILLE, TX AND HENDERSON, KY
24300 A III 10/7/2010 HPT HOCHWERTIGE PHARMATECHNIK
GMBH CO KG
INJECTION BOTTLES WITH CLINCH NECK FINISH AS MANUFACTURED IN NEUHAUS A.
RWG., GERMANY
24301 A III 10/9/2010 TEKNOR APEX CO MEDALIST MD-585 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND
HENDERSON, KY FOR TEKNOR APEX COMPANY
24302 A III 10/9/2010 TEKNOR APEX CO MEDALIST MD-565 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND
HENDERSON, KY FOR TEKNOR APEX COMPANY
24303 A III 10/9/2010 TEKNOR APEX CO MEDALIST MD-575 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND
HENDERSON, KY FOR TEKNOR APEX COMPANY
24304 A II 10/19/2010 CATALENT PHARMA SOLUTIONS LLC DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES AS MANUFACTURED IN ST.
PETERSBURG, FL
24305 A II 10/19/2010 APOTEX PHARMACHEM INDIA PVT LTD ENTECAVIR AS MANUFACTURED IN BANGALORE KARNATAKA, INDIA
24306 A II 10/13/2010 PHARMACEUTICAL WORKS POLPHARMA SA ZOLEDRONIC ACID AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
24307 A II 10/19/2010 MSN ORGANICS PVT LTD SILDENAFIL CITRATE [ROUTE CODE: SE] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
24308 A III 10/21/2010 LANXESS DEUTSCHLAND GMBH LANXESS BROMOBUTYL 2030 AS MANUFACTURED IN ZWIJNDRECHT, BELGIUM AND
SARNIA, ONTARIO, CANADA
24309 A II 10/13/2010 MAPRIMED SA FLECAINIDE ACETATE PROCESS II (CODE 50856) AS MANUFACTURED IN BUENOS AIRES,
ARGENTINA
24310 A II 9/17/2010 PRODUCTOS QUIMICOS NATURALES SA DE
CV PROQUINA
TESTOSTERONE L-2 AS MANUFACTURED IN IXTACZOQUITLAN VER. MEXICO
24311 A II 10/22/2010 MYLAN LABORATORIES LTD FROVATRIPTAN SUCCINATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA,
INDIA
24312 A II 12/1/2010 ARCH PHARMALABS LTD ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR) (ESUB) AS MANUFACTURED IN
HARYANA INDIA FOR ARCH PHARMALABS LIMITED
24313 A II 10/18/2010 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
PANTOPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
24314 A II 11/8/2010 PHARMACIA AND UPJOHN SUB PFIZER INC TRIAZOLAM USP MICRONIZED (ESUB) AS MANUFACTURED IN KALAMAZOO MI
24315 A II 11/30/2010 ABBVIE INC PARICALCITOL DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN SLIGO, IRELAND
24316 A II 10/1/2010 YANTAI DONGCHENG BIOCHEMICALS CO
LTD
ENOXAPARIN SODIUM AS MANUFACTURED IN YANTAI DEVELOPMENT ZONE, SHANDONG
PROVINCE, P.R. CHINA
24317 A II 9/28/2010 KOREA UNITED PHARMACEUTICALS INC AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN CHUNGNAM, REPUBLIC OF
KOREA
Page 724
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24318 A III 10/19/2010 KJ SPECIALTY PAPER CO LTD DDSF-2 SERIES (DDSF-2, DDSF-2FP AND DDSF-2FPS) BACKING FILMS MADE OF PET FILM
AND UNWOVEN CLOTH LAMINATED AS MANUFACTURED IN SHIZUOKA, JAPAN
24319 A III 10/19/2010 KJ SPECIALTY PAPER CO LTD DDSF-151 SERIES (DDSF-151, DDSF-151P AND DDSF-151PS) BACKING FILMS MADE OF
PET FILM AND UNWOVEN CLOTH LAMINATED AS MANUFACTURED IN SHIZUOKA, JAPAN
24320 A IV 10/27/2010 SENSIENT PHARMACEUTICAL COATING
SYSTEMS
SPECTRABLEND COATING SYSTEM AS MANUFACTURED IN ST LOUIS MO
24321 A II 10/28/2010 NAVINTA LLC HYDRALAZINE HYDROCHLORIDE USP (P) GRADE AS MANUFACTURED IN GUJARAT INDIA
FOR NAVINTA LLC
24322 A II 9/15/2010 SAFC BIOSCIENCES INC EX-CELL 325 PF CHO SERUM-FREE PROTEIN FREE W/O L-GLUTAMINE AS
MANUFACTURED IN DENVER PA
24323 A II 10/28/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD PERGOLIDE MESYLATE AS MANUFACTURED IN OPAVA-KOMAROV CZECH REPUBLIC FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
24324 A II 11/2/2010 UNIMARK REMEDIES LTD MONTELUKAST SODIUM (PROCESS B) (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24325 A II 10/25/2010 ZHEJIANG HISUN PHARMACEUTICAL CO LTD ATORVASTATIN CALCIUM AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES
REPUBLIC OF CHINA
24326 A II 10/28/2010 MACLEODS PHARMACEUTICALS LTD ESZOPICLONE AS MANUFACTURED IN GUJARAT INDIA
24327 A II 11/1/2010 SCINOPHARM TAIWAN LTD PEMETREXED DISODIUM AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC
24328 I II 12/21/2010 RPG LIFE SCIENCES LTD CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN MUMBAI INDIA
24329 A III 10/27/2010 PFP TERMOPOLIMEROS SL HDPE/BO-CRC FAB CONTAINER AS MANUFACTURED IN BARCELONA SPAIN
24330 A II 9/10/2010 SPECTRON MRC LLC 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN SOUTH BEND IN
24331 A II 10/25/2010 ERREGIERRE SPA PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH EUR AS MANUFACTURED IN SAN
PAOLO D'ARGON (BG) ITALY
24332 I II 10/8/2010 QILU PHARMACEUTICAL CO LTD ETOPOSIDE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES
REPUBLIC OF CHINA
24333 A II 10/30/2010 MACLEODS PHARMACEUTICALS LTD OLANZAPINE AS MANUFACTURED IN GUJARAT INDIA
24334 A II 4/1/2011 APICORE LLC ZILEUTON USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC
24335 A IV 11/1/2010 AARHUSKARLSHAMN SWEDEN AB SHEA BUTTERS FOR USE AS EXCIPIENTS IN PHARMACEUTICAL PREPARATIONS LIPEX
102 & LIPEX SHEASOFT AS MANUFACTURED IN KARLSHAMN SWEDEN
24336 A II 10/21/2010 ALP PHARM BEIJING CO LTD ADEFOVIR DIPIVOXIL AS MANUFACTURED IN JIANGSU CHINA FOR ALP PHARM BEIJING
CO LTD
24337 I II 11/5/2010 EXCELLA GMBH GANCICLOVIR ANHYDROUS R (ESUB) AS MANUFACTURED IN FEUCHT GERMANY
24338 A II 11/12/2010 GLENMARK GENERICS LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESUB) AS MANUFACTURED IN
GUJARAT INDIA
24339 A II 3/1/2011 GLAXOSMITHKLINE LLC CEFTAZIDIME (ESUB) AS MANUFACTURED IN CUMBRIA, UK FOR GLAXOSMITHKLINE LLC
24340 A II 10/30/2010 NECTAR LIFESCIENCES LTD CEFOTAXIME (NON STERILE DRUG SUBSTANCES INTERMEDIATE) AS MANUFACTURED IN
PUNJAB INDIA
24341 A II 10/29/2010 JARI PHARMACEUTICAL CO LTD GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU CHINA
24342 A III 10/29/2010 SHANDONG WEIGAO GROUP MEDICAL
POLYMER CO LTD
ASSEMBLAGES FOR PREFILLED SYRINGES AS MANUFACTURED IN SHANDONG PR CHINA
24343 A II 12/28/2010 TARO PHARMACEUTICAL INDUSTRIES LTD LEVOCETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL
24344 A IV 10/31/2010 DOSHION LTD POLACRILEX RESIN (DOSHION P551) AS MANUFACTURED IN GUJARAT INDIA
Page 725
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24345 A II 11/4/2010 PHARMACEUTICAL WORKS POLPHARMA SA TOLTERODINE L-TARTRATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND
24346 A II 11/5/2010 SANDOZ PRIVATE LTD POSACONAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA
24347 A II 12/1/2010 WATSON PHARMA PRIVATE LTD ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (ESUB) AS MANUFACTURED IN
THANE DISTRICT INDIA
24348 A II 11/8/2010 HETERO DRUGS LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II AS MANUFACTURED IN ANDHRA
PRADESH INDIA
24349 A II 10/20/2010 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
VENLAFAXINE HYDROCHLORIDE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
24350 P *** PENDING FILING REVIEW ***
24351 A II 11/19/2010 GLENMARK GENERICS LTD PALONOSETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24352 A II 11/9/2010 BEIJING LUNARSUN PHARMACEUTICAL CO
LTD
TEMOZOLOMIDE AS MANUFACTURED IN CHONGQING CHINA FOR BEIJING LUNARSUN
PHARMACEUTICAL CO LTD
24353 A II 1/10/2011 CAYMAN CHEMICAL CO BIMATOPROST DRUG SUBSTANCE AS MANUFACTURED IN ANN ARBOR MI
24354 A II 10/30/2010 NECTAR LIFESCIENCES LTD CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN
PUNJAB INDIA
24355 A III 11/4/2010 BORMIOLI ROCCO SPA BU PLASTICS PET BOTTLE 500 ML - F18048 AS MANUFACTURED IN SAINT SULPICE FRANCE,
RIVANAZZANO (PV) ITALY, AND CASTELGUELFO (PR) ITALY
24356 A II 11/8/2010 LIANYUNGANG RUNZHONG
PHARMACEUTICAL CO LTD
ZOLEDRONIC ACID AS MANUFACTURED IN JIANGSU CHINA
24357 A IV 11/10/2010 SUHEUNG VIETNAM CO LTD GELATIN HARD SHELL CAPSULES AS MANUFACTURED IN DONG NAI PROVINCE VIETNAM
24358 A II 11/8/2010 ANHUI WANBEI PHARMACEUTICAL CO LTD CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN ANHUI PROVINCE CHINA
24359 A II 11/12/2010 HERAEUS PRECIOUS METALS GMBH AND
CO KG
5-AMINOLEVULINIC ACID HYDROCHLORIDE AS MANUFACTURED IN HANAU, GERMANY
24360 A II 11/12/2010 MUSTAFA NEVZAT ILAC SANAYII AS STERILE MIXTURE OF AMPICILLIN SODIUM AND SULBACTAM SODIUM (2:1) AS
MANUFACTURED IN KUNDL TYROL AUSTRIA, KOCAELI TURKEY AND ISTANBUL TURKEY
FOR MUSTAFA NEVZAT ILAC SANAYII AS
24361 A II 12/15/2010 JUBILANT LIFE SCIENCES LTD ENTACAPONE (ESUB) AS MANUFACTURED IN KARNATAKA INDIA
24362 A II 11/11/2010 GLOCHEM INDUSTRIES LTD TELMISARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA
24363 A IV 11/12/2010 NUSIL TECHNOLOGY LLC MED50 -5336 AS MANUFACTURED IN CARPINTERIA CA
24364 A IV 11/12/2010 NUSIL TECHNOLOGY LLC MED-6602 AS MANUFACTURED IN CARPINTERIA CA
24365 A III 11/12/2010 LOTTE ALUMINIUM CO LTD CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO KOREA
24366 A III 11/8/2010 RUBY SURGICAL AND ALLIED PRODUCTS
PRIVATE LTD
POLYESTER COILS AS MANUFACTURED IN JALGAON INDIA
24367 A II 11/15/2010 HOSPIRA BOULDER INC OXALIPLATIN DRUG SUBSTANCE AS MANUFACTURED IN BOULDER CO
24368 A II 11/12/2010 BASF PHARMA EVIONNAZ SA ENAMINE AMIDE AS MANUFACTURED IN EVIONNAZ SWITZERLAND
24369 A II 11/15/2010 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
N-METHYLPAROXETINE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR
ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD
24370 A II 11/9/2010 INTAS PHARMACEUTICALS LTD CAPECITABINE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA
Page 726
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24371 A II 11/25/2010 AUROBINDO PHARMA LTD MOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (ESUB)
ANDHRA PRADESH INDIA
24372 A II 11/15/2010 CHUNGHWA CHEMICAL SYNTHESIS AND
BIOTECH CO LTD
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN
TAIPEI HSIEN, TAIWAN
24373 A II 12/1/2010 UNICHEM LABORATORIES LTD LACIDIPINE (ESUB) AS MANUFACTURED IN ROHA DIST RAIGAD INDIA
24374 A II 12/1/2010 UNICHEM LABORATORIES LTD TAMSULOSIN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ROHA DIST RAIGAD
INDIA
24375 A IV 11/15/2010 EASTMAN CHEMICAL CO EASTMAN CELLULOSE ACETATE BUTYRATE (CAB-381-20BP) AS MANUFACTURED IN
KINGSPORT TN
24376 A II 11/1/2010 ALP PHARM BEIJING CO LTD NELARABINE AS MANUFACTURED IN JILIN PROVINCE CHINA FOR ALP PHARM BEIJING CO
LTD
24377 A II 11/4/2010 ALP PHARM BEIJING CO LTD VERTEPORFIN AS MANUFACTURED IN JIANGSU PROVINCE CHINA FOR ALP PHARM
BEIJING CO LTD
24378 A II 11/5/2010 ALP PHARM BEIJING CO LTD LANREOTIDE AS MANUFACTURED IN SHANGHAI CHINA FOR ALP PHARM BEIJING CO LTD
24379 A IV 2/22/2011 BIOSPECTRA UREA AS MANUFACTURED IN STROUDSBURG, PA
24380 A IV 2/22/2011 BIOSPECTRA TROMETHAMINE AS MANUFACTURED IN STROUDSBURG, PA
24381 A II 11/17/2010 MACLEODS PHARMACEUTICALS LTD MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA
24382 A III 10/29/2010 EZCAP INTERNATIONAL CO LTD CHILD RESISTANT CLOSURES AS MANUFACTURED IN KYUNGGI DO KOREA
24383 A II 12/2/2010 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
RITONAVIR USP AS MANUFACTURED IN SHANGHAI CHINA
24384 A IV 8/12/2010 SEPPIC SA MONTANOX 80 API AS MANUFACTURED IN CASTRES CEDEX FRANCE FOR SEPPIC SA
24385 A II 11/30/2010 FRESENIUS KABI ONCOLOGY LTD BUSULFAN (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA
24386 A II 3/30/2011 EXCELLA GMBH MASITINIB MESYLATE (ESUB) AS MANUFACTURED IN FEUCHT GERMANY
24387 A II 11/22/2010 INTERQUIM SA PALIPERIDONE AS MANUFACTURED IN BARCELONA SPAIN AND ESTADO DE MEXICO
(MEXICO) FOR INTERQUIM SA
24388 A II 11/23/2010 DR REDDYS LABORATORIES LTD PEMETREXED DISODIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24389 A IV 11/22/2010 BASF SE KOLLICOAT SMARTSEAL 30 D AS MANUFACTURED IN LUDWIGHAFEN, GERMANY
24390 A IV 10/26/2010 NUSIL TECHNOLOGY LLC MED-344 (ANTIFOAM 7120) AS MANUFACTURED IN BAKERSFIELD CA
24391 A IV 10/26/2010 NUSIL TECHNOLOGY LLC MED-346 (ANTIFOAM 70451) AS MANUFACTURED IN BAKERSFIELD CA
24392 A IV 10/26/2010 NUSIL TECHNOLOGY LLC MED-347 SIMETHICONE AS MANUFACTURED IN BAKERSFIELD CA
24393 A II 12/10/2010 UNICHEM LABORATORIES LTD FENOFIBRATE USP (ESUB) AS MANUFACTURED IN DHAVAT-ROHA DIST RAIGAD INDIA
24394 A II 3/31/2011 LUPIN LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24395 A II 3/31/2011 ACS DOBFAR SPA CEFEPIME FOR INJECTION (STERILE BULK) (ESUB) AS MANUFACTURED IN MILANO, ITALY
24396 A III 8/26/2009 TREDEGAR FILM PRODUCTS CORP CEX-816WR ELASTIC FILM (35621, 35618) AS MANUFACTURED IN LAKE ZURICH IL
24397 A II 11/19/2010 FORMOSA LABORATORIES INC MYCOPHENOLATE SODIUM AS MANUFACTURED IN TAOYUAN TAIWAN
24398 A II 9/9/2010 SEPPIC SA MONTANOX 80 LPI AS MANUFACTURED IN CASTRES CEDEX FRANCE FOR SEPPIC SA
24399 A IV 11/24/2010 VIKRAM THERMO INDIA LTD METHACRYLIC ACID COPOLYMER TYPE A NF AS MANUFACTURED IN GUJARAT INDIA
24400 A II 11/28/2010 ASAHI GLASS CO LTD TAFLUPROST DRUG SUBSTANCE AS MANUFACTURED IN CHIBA JAPAN
24401 A II 11/10/2010 SHANDONG YIBAO BIOLOGICS CO LTD CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE CHINA
24402 A II 10/25/2011 EXCELLA GMBH LEVOTHYROXINE SODIUM (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY
24403 A II 11/29/2010 MYLAN LABORATORIES LTD CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA
Page 727
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24404 A IV 11/29/2010 HENKEL CORP DURO-TAK 87-608A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY
NC
24405 A III 10/29/2010 SARONG ALUMINUM/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN MANDELLO DEL
LARIO (LC) ITALY AND BAGNATICA (BERGAMO) ITALY FOR SARONG
24406 A II 11/30/2010 HETERO DRUGS LTD PANTOPRAZOLE SODIUM SESQUIHYDRATE, USP (PROCESS II) AS MANUFACTURED IN
ANDHRA PRADESH INDIA
24407 A II 11/17/2010 OLON SPA TOREMIFENE CITRATE AS MANUFACTURED IN RODANO (MI) ITALY
24408 A II 12/17/2010 PHF SA OLOPATADINE HCI USP (ESUB) AS MANUFACTURED IN VICENZA ITALY
24409 I II 11/22/2010 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
METAXALONE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
24410 A II 11/30/2010 EMCURE PHARMACEUTICALS LTD CIDOFOVIR DIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA
24411 A II 3/1/2011 GLAXOSMITHKLINE LLC CEFUROXIME SODIUM (ESUB) AS MANUFACTURED IN CORK, IRELAND FOR
GLAXOSMITHKLINE LLC
24412 A II 12/1/2010 SANDOZ INDUSTRIAL PRODUCTS GMBH CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN FRANKFURT, GERMANY AND
KUNDL AUSTRIA FOR SANDOZ INDUSTRIAL PRODUCTS GMBH
24413 A III 11/18/2010 ACG PHARMAPACK PVT LTD RIGID PACKAGING FILMS AS MANUFACTURED IN MAHARASHTRA INDIA
24414 A III 11/23/2010 TEKNOR APEX CO MEDALIST MD-160A NATURAL AS MANUFACTURED IN SAINT ALBANS VT AND
HENDERSON KY FOR TEKNOR APEX COMPANY
24415 N NOT AN ASSIGNED NUMBER
24416 A II 3/7/2011 VALDEPHARM NORETHINDRONE (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE
24417 A IV 12/1/2010 MEXICHEM UK LTD BLENDS OF INHALATION GRADE 1, 1, 1, 2, 2, 2, 3-HEPTAFLUOROPROPANE AND
INHALATION GRADE 1,1,1,2-TETRAFLUOROETHANE AS MANUFACTURED IN RUNCORN
CHESHIRE UNITED KINGDOM
24418 A II 12/2/2010 NOBILUS ENT DIGOXIN AS MANUFACTURED IN KUTNO POLAND
24419 A II 11/30/2010 ALEMBIC PHARMACEUTICALS LTD CELECOXIB AS MANUFACTURED IN GUJARAT INDIA
24420 I II 12/7/2010 RANBAXY LABORATORIES LTD TRETINOIN USP (NON STERILE BULK) AS MANUFACTURED IN PUNJAB INDIA
24421 A II 12/7/2010 DR REDDYS LABORATORIES LTD ABACAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA
24422 A II 12/7/2010 KREATIVE ORGANICS (P) LTD ETODOLAC USP AS MANUFACTURED IN ANDHRA PRADESH INDIA
24423 A II 1/15/2011 SUN PHARMACEUTICAL INDUSTRIES LTD BIVALIRUDIN (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
24424 A II 12/13/2010 SRI KRISHNA PHARMACEUTICALS LTD DOMPERIDONE PH EUR (ESUB) AS MANUFACTURED IN HYDERABAD INDIA
24425 N NOT AN ASSIGNED NUMBER
24426 A III 12/14/2010 CODING PRODUCTS TTR-71523 AS MANUFACTURED IN KALKASKA MI
24427 A III 11/25/2010 MEDIPHARMAPLAN CO LTD CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO KOREA
24428 A III 11/29/2010 FUJIMORI KOGYO CO LTD PLASTIC FILMS AND BAG FOR USE IN OUTER PACKAGING OF DRUG PRODUCT AS
MANUFACTURED IN MIE PREFECTURE JAPAN
24429 I II 12/8/2010 RANBAXY LABORATORIES LTD TELBIVUDINE AS MANUFACTURED IN PUNJAB INDIA
24430 A II 11/11/2010 OLON SPA ACITRETIN (FORM I) AS MANUFACTURED IN GARBAGNATE MILANESE (MI) ITALY
24431 A IV 12/6/2010 HENKEL CORP DURO-TAK 87-6900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY
NC
24432 I II 12/9/2010 RANBAXY LABORATORIES LTD OLMESARTAN MEDOXOMIL AS MANUFACTURED IN PUNJAB INDIA
Page 728
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24433 I II 12/9/2010 OCEAN NUTRITION CANADA LTD OMEGA-3 ACID ETHYL ESTERS AS MANUFACTURED IN CHARLOTTETOWN PE CANADA
FOR OCEAN NUTRITION CANADA LTD
24434 A II 12/8/2010 APOTEX PHARMACHEM INC VALGANCICLOVIR HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA INDIA FOR
APOTEX PHARMACHEM INC
24435 A II 12/10/2010 CATALENT PHARMA SOLUTIONS LLC SOFT GELATIN CAPSULE MANUFACTURING PROCESS FOR OET-10275167 AS
MANUFACTURED IN ST PETERSBURG FL
24436 A III 12/1/2010 HUBENA CO LTD GLASS VIALS & GLASS AMPOULES AS MANUFACTURED IN CHOONG NAM-DO KOREA
24437 A II 12/10/2010 VIRUPAKSHA ORGANICS PVT LTD FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA
24438 A II 12/10/2010 JIANGSU JIAERKE PHARMACEUTICALS
GROUP CORP LTD
PRASTERONE ACETATE AS MANUFACTURED IN JIANGSU CHINA
24439 A II 12/8/2010 ZHEJIANG HISUN PHARMACEUTICAL CO LTD CAPREOMYCIN SULFATE AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES
REPUBLIC OF CHINA
24440 A IV 12/6/2010 UNGERER AND CO NATURAL AND ARTIFICIAL YELLOW PLUM LEMON FLAVOR FT-5399 AS MANUFACTURED
IN BETHLEHEM PA
24441 A II 12/13/2010 MYLAN LABORATORIES LTD DIPYRIDAMOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA
24442 A II 12/13/2010 MYLAN LABORATORIES LTD RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED MAHARASHTRA INDIA
24443 A II 2/14/2011 PHF SA QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN QUEBEC, CANADA FOR PHF SA
24444 A IV 12/6/2010 DOW CORNING CORP DOW CORNING ST-DIMETHICONOL 40 AS MANUFACTURED IN HEMLOCK MI
24445 A II 12/13/2010 MOREPEN LABORATORIES LTD MONTELUKAST SODIUM AS MANUFACTURED IN HIMACHAL PRADESH INDIA
24446 A II 12/15/2010 HETERO DRUGS LTD ATOVAQUONE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24447 A II 12/15/2010 RANBAXY LABORATORIES LTD SOLIFENACIN SUCCINATE AS MANUFACTURED IN PUNJAB INDIA
24448 I II 12/15/2010 RANBAXY LABORATORIES LTD PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA
24449 A II 11/22/2010 SPECIALTY ENZYMES AND BIOCHEMICALS
CO
ALPHA GALATOSIDASE AS MANUFACTURED IN SINNAR (NASHIK) INDIA FOR SPECIALTY
ENZYMES AND BIOCHEMICALS CO
24450 I II 12/17/2010 MYLAN LABORATORIES LTD ZIDOVUDINE USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24451 A II 12/14/2010 LONZA BRAINE SA SECRETIN DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-L ALLEUD BELGIUM
24452 A II 12/15/2010 MACLEODS PHARMACEUTICALS LTD ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN GUJARAT INDIA
24453 A II 11/18/2010 JIANGSU NHWA PHARMACEUTICAL CO LTD FENOFIBRATE AS MANUFACTURED IN JIANGSU CHINA
24454 A II 12/14/2010 PARABOLIC DRUGS LTD CEFTIZOXIME SODIUM (STERILE) USP AS MANUFACTURED IN PUNJAB INDIA
24455 A IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4573.5P PHA VANILLA FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND
TORINO (TO) ITALY
24456 A IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4562.4P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND
TORINO (TO) ITALY
24457 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3478.1P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND
TORINO (TO) ITALY
24458 A II 2/2/2011 GLAXOSMITHKLINE LLC TOPOTECAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN CORK, IRELAND FOR
GLAXOSMITHKLINE LLC
24459 A IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.4108.UL PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND
TORINO (TO) ITALY
24460 A V 12/14/2010 BASF SE KOLLICOAT SMARTSEAL 30 D PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN
LUDWIGSHAFEN, GERMANY
24461 A II 12/17/2010 CATALENT PHARMA SOLUTIONS LLC SOFT GELATIN CAPSULE MANUFACTURING PROCESS FORMULA OET-10275188 (ESUB)
AS MANUFACTURED IN ST PETERSBURG FL
24462 A IV 12/17/2010 NUSIL TECHNOLOGY LLC MED-4840 AS MANUFACTURED IN CARPINTERIA CA
24463 A II 12/17/2010 EUTICALS INC OMEGA-3 ACID ETHYL ESTERS DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD
MO Page 729
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24464 A IV 12/17/2010 ASHA CELLULOSE I PVT LTD ASHACEL ETHYL CELLULOSE AS MANUFACTURED IN VALSAD INDIA
24465 A II 12/20/2010 JIAOZUO JOINCARE BIOTECHNOLOGICAL
CO LTD
7-AMINOCEPHALOSPORANIC ACID AS MANUFACTURED IN HENAN PR CHINA
24466 A III 12/20/2010 THE DOW CHEMICAL COMPANY ETHYLENE/VINYL ACETATE CO-POLYMER FORMULATIONS AS MANUFACTURED IN ELK
GROVE VILLAGE IL AND RINGWOOD IL
24467 A III 11/19/2010 SARONG POLYVINYLCHLORIDE/POLVINYLIDENE CHLORIDE/POLYETHYLENE FILM LAMINATE AS
MANUFACTURED IN REGGIOLO (RE) ITALY
24468 A II 2/24/2011 CONCORD BIOTECH LTD SIROLIMIUS (ESUB) AS MANUFACTURED IN AHMEDABAD, INDIA
24469 A II 12/24/2010 USV LIMITED ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
24470 A V 3/6/2013 NOVO NORDISK INC STERILIZATION VALIDATION INFORMATION (ESUB)
24471 A II 2/11/2011 GLAXOSMITHKLINE AMOXICILLIN SODIUM (ESUB) AS MANUFACTURED IN WEST SUSSEX, UNITED KINGDOM
FOR GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE
24472 A II 1/5/2011 IND SWIFT LABORATORIES LTD TELMISARTAN (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
24473 A III 12/21/2010 PPG PACKAGING AND COATINGS PPG5085-301 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH
24474 A III 12/21/2010 PPG PACKAGING AND COATINGS PPG5085-302 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH
24475 A III 12/21/2010 PPG PACKAGING AND COATINGS PPG5085-304 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH
24476 A II 12/8/2010 SHANDONG XINHUA PHARMACEUTICAL CO
LTD
MELOXICAM AS MANUFACTURED IN SHANDONG PR CHINA
24477 A II 10/1/2010 VITAL LABORATORIES PVT LTD SCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL BROMIDE) AS MANUFACTURED IN
GUJARAT INDIA
24478 A III 12/21/2010 HOSOKAWA YOKO CO LTD POLYOLEFIN BAGS AND FILM (POLYELITE SERIES) FOR PHARMACEUTICAL CONTAINER
USE AS MANUFACTURED IN NAGANO JAPAN FOR HOSOKAWA YOKO CO LTD
24479 A II 12/21/2010 GEDEON RICHTER PLC DIENOGEST AS MANUFACTURED IN DOROG HUNGARY
24480 A II 12/20/2010 JIANGSU HANSOH PHARMACEUTICAL CO
LTD
OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU
CHINA
24481 A II 12/22/2010 FORMOSA LABORATORIES INC ILOPERIDONE AS MANUFACTURED IN TAOYUAN TAIWAN
24482 A II 12/17/2010 CODING PRODUCTS TTR-74808 AS MANUFACTURED IN KALKASKA MI
24483 A III 12/15/2010 EASTMAN CHEMICAL CO EASTMAN TRITAN COPOLYESTER PRODUCTION AT TENNESSEE EASTMAN DIVISION AS
MANUFACTURED IN KINGSPORT TN
24484 A III 12/22/2010 BESPAK DIV CONSORT MEDICAL PLC BK357 AND BK361 VALVE SPECIFIC INFORMATION AS MANUFACTURED IN NORFOLK,
ENGLAND
24485 A II 12/23/2010 MYLAN LABORATORIES LTD RIVASTIGMINE AS MANUFACTURED IN MAHARASHTRA INDIA
24486 A II 10/12/2010 SYMBIOTICA SPECIALITY INGREDIENTS SDN
BHD
BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN KULIM, KEDAH, MALAYSIA
24487 A II 12/23/2010 CHEMO IBERICA SA LANSOPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE PR OF CHINA FOR CHEMO
IBERICA SA
24488 A IV 12/22/2010 3M DRUG DELIVERY SYSTEMS SOLVATED ACRYLATE COPOLYMER ADHESIVE R-24449 AS MANUFACTURED IN
CORDOVA IL FOR 3M DRUG DELIVERY SYSTEMS DIVISION
24489 A III 12/23/2010 BORMIOLI ROCCO SPA BU PLASTICS OVERTUNING DROPPER 0.65 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY,
RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE
24490 A III 12/23/2010 BORMIOLI ROCCO E FIGLIO SPA BU
PLASTICA
TAMPER EVIDENT CLOSURE 15 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY,
RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE
24491 A III 12/23/2010 BORMIOLI ROCCO SPA BU PLASTICS LDPE BOTTLE 10 ML AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, RIVANAZZANO
(PV) ITALY, AND SAINT SULPICE FRANCE
24492 A IV 12/21/2010 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
DISINTEQUIK MCC 25 AS MANUFACTURED IN ROTHSCHILD WI FOR KERRY
BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIOSCIENCE
Page 730
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24493 A III 12/20/2010 BRIGHTWOOD PHARMMED CONSUMABLE
BEIJING LTD
MULTILAYER FILM (MF518) AS MANUFACTURED IN HUAI ROU COUNTY BEIJING PR CHINA
AND TONGZHOU INDUSTRY DISTRICT BEIJING PR CHINA
24494 A III 12/21/2010 SCHOTT KAISHA PVT LTD NEUTRAL GLASS SULPHUR TREATED VIALS AS MANUFACTURED IN NANI DAMAN INDIA
24495 A II 12/28/2010 COVALENT LABORATORIES PRIVATE LTD CEFUROXIME ACID (ACETONE ROUTE) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24496 A II 2/21/2011 JUBILANT LIFE SCIENCES LTD CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24497 A II 12/23/2010 ROLABO OUTSOURCING SL PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ZARAGOZA, SPAIN
24498 A II 12/28/2010 NAVINTA LLC TAUROLIDINE AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR NAVINTA LLC
24499 A II 12/28/2010 MYLAN LABORATORIES LTD ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA
24500 A II 3/1/2011 PFIZER INC TESTOSTERONE UNDECANOATE (ESUB) AS MANUFACTURED IN KALAMAZOO, MICHIGAN
24501 A II 3/27/2011 JUBILANT LIFE SCIENCES LTD RIVASTIGMINE TARTRATE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24502 A II 3/27/2011 JUBILANT LIFE SCIENCES LTD RIVASTIGMINE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24503 A II 12/21/2010 MYLAN LABORATORIES LTD DEXLANSOPRAZOLE SESQUIHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24504 A II 12/28/2010 MYLAN LABORATORIES LTD ELETRIPTAN HYDROBROMIDE (PROCESS 1) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24505 A II 12/21/2010 MYLAN LABORATORIES LTD AMBRISENTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24506 A II 12/29/2010 NEULAND LABORATORIES LTD LINEZOLID (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24507 A II 12/20/2010 BLOOMAGE FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-EP 3.0) AS MANUFACTURED IN SHANDONG PROVINCE, P.R.
OF CHINA
24508 A II 12/20/2010 BLOOMAGE FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-EP 1.8) AS MANUFACTURED IN SHANDONG PROVINCE, P.R.
OF CHINA
24509 A II 12/30/2010 MYLAN LABORATORIES LTD SUNITINIB MALATE AS MANUFACTURED IN MAHARASHTRA, INDIA
24510 A II 12/30/2010 SCINOPHARM TAIWAN LTD CLADRIBINE AS MANUFACTURED IN TAINAN, TAIWAN
24511 A II 12/30/2010 CHANGZHOU PHARMACEUTICAL FACTORY EZETIMIBE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
24512 A III 12/28/2010 AMPACET CORP 502997 AS PE MB AS MANUFACTURED IN MESSANCY, BELGIUM AND TELGATE (BG), ITALY
FOR AMPACET CORP
24513 A II 3/31/2011 LUPIN LTD DIENOGEST (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24514 A IV 12/30/2010 SENSIENT FLAVORS LLC NATURAL AND ARTIFICIAL SPRAY DRIED CITRUS TYPE FLAVORS AS MANUFACTURED IN
INDIANAPOLIS, INDIANA
24515 A III 12/30/2010 GOPALDAS VISRAM AND CO LTD BOTTLES AS MANUFACTURED IN KUNDAIM, GOA, INDIA
24516 A II 12/31/2010 DR REDDYS LABORATORIES LTD MONTELUKAST SODIUM [PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24517 A II 1/3/2011 CADILA HEALTHCARE LTD CAPECITABINE USP AS MANUFACTURED IN GUJARAT, INDIA
24518 A II 12/29/2010 ZHEJIANG SANMEN HENGKANG
PHARMACEUTICAL CO LTD
AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA
24519 A II 3/22/2011 JUBILANT LIFE SCIENCES LTD REPAGLINIDE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24520 A II 1/17/2011 AUROBINDO PHARMA LTD NEVIRAPINE ANHYDROUS USP (PROCESS II) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24521 A II 5/20/2011 CHEMWERTH INC BROMFENAC SODIUM (SESQUIHYDRATE) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA FOR CHEMWERTH INC
24522 A II 1/4/2011 CADILA HEALTHCARE LTD DICLOFENAC EPOLAMINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24523 A II 12/15/2010 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
BENZOCAINE AS MANUFACTURED IN GUJARAT, INDIA
Page 731
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24524 A II 1/19/2011 GLENMARK GENERICS LTD CHOLINE FENOFIBRATE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
24525 A II 12/31/2010 SARV BIO LABS PVT LTD COLCHICINE USP AS MANUFACTURED IN HIMACHAL PRADESH, INDIA
24526 A II 1/5/2011 ALEMBIC PHARMACEUTICALS LTD METOPROLOL TARTRATE USP AS MANUFACTURED IN GUJARAT, INDIA
24527 A II 1/4/2011 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
CEFAZOLIN SODIUM (STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA
24528 A II 12/29/2010 FIS FABBRICA ITALIANA SINTETICI SPA ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN VICENZA, ITALY
24529 I II 12/31/2010 QILU TIANHE PHARMACEUTICAL CO LTD CAPECITABINE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
24530 A II 1/5/2011 DSM NUTRITIONAL PRODUCTS LTD PHYTOMENADIONE (VITAMIN K1) AS MANUFACTURED IN SISSELN, SWITZERLAND FOR
DSM NUTRITIONAL PRODUCTS LTD
24531 A II 1/6/2011 APOTEX PHARMACHEM INDIA PVT LTD DOLASETRON MESYLATE MONOHYDRATE USP AS MANUFACTURED IN KARNATAKA
STATE, INDIA
24532 A II 1/6/2011 NURAY CHEMICALS PVT LTD ATORVASTATIN CALCIUM AMORPHOUS (NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN TAMIL NADU, INDIA
24533 P *** PENDING FILING REVIEW ***
24534 A III 12/15/2010 SUZHOU HAISHUN PACKAGING MATERIAL
CO LTD
PCTFE/PVC COMPOSITE SHEET FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN SUZHOU, P.R. CHINA
24535 A III 12/15/2010 SUZHOU HAISHUN PACKAGING MATERIAL
CO LTD
ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU,
P.R. CHINA
24536 A III 12/15/2010 SUZHOU HAISHUN PACKAGING MATERIAL
CO LTD
POLYAMIDE/ALUMINIUM/PVC COLD-FORMED FOIL FOR PHARMACEUTICAL PACKAGING
AS MANUFACTURED IN SUZHOU, P.R. CHINA
24537 A II 1/4/2011 PARABOLIC DRUGS LTD CEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP AS MANUFACTURED IN PUNJAB,
INDIA
24538 A II 1/7/2011 CADILA HEALTHCARE LTD ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
24539 A III 12/15/2010 PAREKHPLAST INDIA LTD HDPE BOTTLES WITH CAPS AS MANUFACTURED IN MAHARASHTRA, INDIA
24540 A II 1/7/2011 MOEHS IBERICA SL CHOLINE FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN FOR MOEHS
IBERICA SL
24541 A II 1/7/2011 MOEHS IBERICA SL QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN AND SANTANDER,
SPAIN FOR MOEHS IBERICA SL
24542 A II 1/31/2011 USV LIMITED OLOPATADINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24543 A II 1/7/2011 NEWCHEM SPA TRIAMCINOLONE ACETONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY
24544 A II 3/2/2011 AUROBINDO PHARMA LTD VALSARTAN USP (PROCESS II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24545 A II 12/17/2010 SAFC INC HALOFUGINONE LACTATE AS MANUFACTURED IN MADISON, WI
24546 A II 1/12/2011 UQUIFA MEXICO SA DE CV CARISOPRODOL AS MANUFACTURED IN MORELOS, MEXICO
24547 P *** PENDING FILING REVIEW ***
24548 A II 1/4/2011 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
LEVALBUTEROL L-TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
24549 A II 12/22/2010 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
TORSEMIDE, USP AS MANUFACTURED IN ZHEJIANG, CHINA
24550 I II 12/23/2010 MYLAN LABORATORIES LTD ZIDOVUDINE USP (PROCESS III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
MYLAN LABORATORIES LTD
24551 A III 1/5/2011 BV RUBBERFABRIEK WITTENBURG TPE W4509 THERMOPLASTIC ELASTOMER COMPOUND FOR VIAL CAPS & CLOSURES AS
MANUFACTURED IN THE NETHERLANDS
24552 A II 1/15/2011 MACLEODS PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT, INDIA
Page 732
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24553 A II 1/18/2011 GEDEON RICHTER PLC ESTRADIOL VALERATE AS MANUFACTURED IN BUDAPEST, HUNGARY
24554 A III 12/21/2010 GERRESHEIMER REGENSBURG GMBH ALMIRALL INHALER AS MANUFACTURED IN PFREIMD, GERMANY
24555 A III 1/10/2011 AMPACET CORP 120919 SILVER PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA, AND HEATH OH
24556 A III 1/10/2011 AMPACET CORP 120937 GOLD PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA, AND HEATH OH
24557 A II 1/19/2011 HETERO DRUGS LTD CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24558 A V 1/10/2011 WEST PHARMACEUTICAL SERVICES INC CRYSTAL ZENITH (CZ) VIAL READY-TO-USE AS MANUFACTURED IN MONTGOMERY PA,
SCOTTSDALE AZ, LIONVILLE PA, SAN DIEGO CA, AND SALT LAKE CITY UT FOR WEST
PHARMACEUTICAL SERVICES INC
24559 A II 1/18/2011 EMCURE PHARMACEUTICALS LTD OXALIPLATIN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24560 A II 1/19/2011 CARDINAL HEALTH 414 LLC SODIUM ACETATE C-11 INJECTION AS MANUFACTURED IN PHOENIX, AZ
24561 A II 1/19/2011 SYNTHON BV LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BLANSKO, CZECH
REPUBLIC FOR SYNTHON BV
24562 A II 12/27/2010 MEDAC GESELLSCHAFT FUR KLINISCHE
SPEZIALPRAPARATE MBH
5-AMINOLEVULINIC ACID HYDROCHLORIDE 30 MG/ML POWDER FOR ORAL SOLUTION AS
MANUFACTURED IN DESSAU-ROSSLAU, GERMANY AND WEDEL, GERMANY FOR MEDAC
GESELLSCHAFT FUER KLINISCHE SPEZIALPRAEPARATE MBH
24563 P *** PENDING FILING REVIEW ***
24564 A II 1/19/2011 MACLEODS PHARMACEUTICALS LTD TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA
24565 A III 1/25/2011 SHINTECH INC POLYVINYL CHLORIDE HOMOPOLYMER RESIN AS MANUFACTURED IN FREEPORT TX,
ADDIS LA, AND PLAQUEMINE LA FOR SHINTECH INC
24566 A IV 1/21/2011 NIPRO PATCH CO LTD A06 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SAITAMA, JAPAN FOR
NIPRO PATCH CO LTD
24567 A III 1/21/2011 POLYONE CORP EM1001977260 AS MANUFACTURED IN AVON LAKE, OH
24568 A III 1/21/2011 POLYONE CORP EM1001977660 AS MANUFACTURED IN AVON LAKE, OH
24569 A III 1/21/2011 POLYONE CORP EM1001977360 AS MANUFACTURED IN AVON LAKE, OH
24570 A III 1/21/2011 POLYONE CORP EM1001978560 AS MANUFACTURED IN AVON LAKE, OH
24571 A III 1/21/2011 POLYONE CORP EM1001978460 AS MANUFACTURED IN AVON LAKE, OH
24572 A III 1/21/2011 POLYONE CORP EM1001977460 AS MANUFACTURED IN AVON LAKE, OH
24573 P *** PENDING FILING REVIEW ***
24574 A II 2/3/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
PALIPERIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24575 A III 1/20/2011 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BLUE PP5M176067-ZN AS MANUFACTURED IN MALMO, SWEDEN
24576 A IV 1/20/2011 MANTROSE HAEUSER CO INC MANTROCEL K-100M AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA FOR
MANTROSE HAEUSER CO INC
24577 A II 3/8/2011 JUBILANT LIFE SCIENCES LTD VALACYCLOVIR HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24578 I II 3/10/2011 NATCO PHARMA LTD SORAFENIB TOSYLATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24579 A II 1/24/2011 MERCK AND CIE DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND
24580 A II 1/12/2011 HENAN DONGTAI PHARM CO LTD DICLOFENAC SODIUM AS MANUFACTURED IN HENAN PROVINCE, CHINA
24581 A V 2/2/2011 FDA CDER DIV NEUROLOGY PRODUCTS FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY
MONOTHERAPY CLINICAL TRIALS
24582 A II 3/23/2011 GLAXOSMITHKLINE LLC SALMETEROL XINAFOATE (ESUB) AS MANUFACTURED IN MONTROSE, UK; JURONG,
SINGAPORE; WARE, UK; EVREUX, FRANCE FOR GLAXOSMITHKLINE LLC
Page 733
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24583 A II 1/26/2011 TAIZHOU TAIFA PHARMACEUTICALS CO LTD MEGESTROL ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA
24584 A II 2/1/2011 PARABOLIC DRUGS LTD CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-III AS MANUFACTURED IN PUNJAB, INDIA
24585 A II 1/28/2011 SIFAVITOR SRL HALOPERIDOL AS MANUFACTURED IN LODI, ITALY
24586 A II 2/15/2011 IND SWIFT LABORATORIES LTD CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
24587 A II 3/1/2011 SUN PHARMACEUTICAL INDUSTRIES LTD SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24588 A II 3/23/2011 SUN PHARMACEUTICAL INDUSTRIES LTD MONTELUKAST SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24589 A II 2/1/2011 APOTEX PHARMACHEM INDIA PVT LTD RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA FOR
APOTEX PHARMACHEM INC
24590 A II 1/31/2011 PHARMACEUTICAL WORKS POLPHARMA SA TADALAFIL AS MANUFACTURED IN GDANSKI, POLAND
24591 A II 1/31/2011 ALCHYMARS ICM SM PRIVATE LTD RISEDRONATE SODIUM USP AS MANUFACTURED IN TAMILNADU, INDIA
24592 A II 1/31/2011 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
MEGESTROL ACETATE USP (NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN ZHEJIANG, CHINA
24593 A II 2/1/2011 PARABOLIC DRUGS LTD CEFUROXIME ACID (PROCESS-III) AS MANUFACTURED IN PUNJAB, INDIA
24594 A II 1/24/2011 AREVIPHARMA GMBH BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY
24595 A II 1/21/2011 HEBEI CHANGSHAN BIOCHEMICAL
PHARMACEUTICAL CO LTD
HEPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, PEOPLE'S REPUBLIC OF
CHINA
24596 A II 4/19/2011 CTX LIFE SCIENCES PVT LTD IRBESARTAN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24597 A II 3/5/2011 IND SWIFT LABORATORIES LTD FEXOFENADINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
24598 A II 1/21/2011 SIFAVITOR SRL CLODRONATE DISODIUM TETRAHYDRATE AS MANUFACTURED IN LODI, ITALY
24599 A II 2/1/2011 DR REDDYS LABORATORIES LTD LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24600 A II 1/28/2011 DR REDDYS LABORATORIES LTD PALIPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24601 A II 1/28/2011 CHONGQING CARELIFE PHARMACEUTICAL
CO LTD
ENTECAVIR HYDRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, PEOPLE'S REPUBLIC OF CHINA
24602 A III 1/13/2011 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN BROWN COLORANT MASTERBATCHES N08554-1, N08554-2, AND
N08554-3 AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
24603 A II 1/31/2011 RAKS PHARMA PVT LTD PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24604 A II 1/17/2011 SHANDONG KEYUAN PHARMACEUTICAL CO
LTD
METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
24605 A III 1/21/2011 BASF SE ULTRADUR B4520 PRO UNCOLORED AS MANUFACTURED IN SCHWARZHEIDE,
GERMANY FOR BASF SE
24606 A III 1/21/2011 BASF SE ULTRAFORM H4320 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
24607 A III 1/21/2011 BASF SE ULTRAFORM N2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
24608 A II 2/3/2011 HETERO LABS LTD ZIDOVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24609 A II 2/3/2011 HETERO LABS LTD LAMIVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24610 A II 2/3/2011 HETERO LABS LTD NEVIRAPINE ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24611 A II 2/3/2011 SYMBIOTEC PHARMALAB LTD METHYLPREDNISOLONE ACETATE USP AS MANUFACTURED IN INDORE (M.P), INDIA
24612 P *** PENDING FILING REVIEW ***
24613 I II 10/7/2011 IPCA LABORATORIES LTD PANTOPRAZOLE SODIUM USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24614 A II 2/4/2011 CENTER MOLECULAR RESEARCH LLC OXYGEN-18 ENRICHED WATER AS MANUFACTURED IN MOSCOW, RUSSIA
Page 734
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24615 A II 5/3/2011 APICORE LLC MAFENIDE ACETATE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE
LLC
24616 A III 1/28/2011 AMPACET CORP 111717-B WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA; AND HEATH, OH
24617 A IV 1/28/2011 ABELEI INC 174A91 NATURAL & ARTIFICIAL COOL MINT FLAVOR AS MANUFACTURED IN NORTH
AURORA, IL
24618 A III 2/3/2011 AMPACET CORP 163814 SPRING WATER BLUE PE MB AS MANUFACTURED IN TERRE HAUTE, IN;
DERIDDER, LA; CARTERSVILLE, GA; AND HEATH, OH
24619 A II 6/27/2012 TARO PHARMACEUTICAL INDUSTRIES LTD NAFTIFINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL
24620 A IV 9/8/2010 TAKASAGO INTERNATIONAL CORP TAK-093146 MICRON ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN
TETERBORO, NJ
24621 A II 2/8/2011 CHONGQING HUAPONT PHARMACEUTICAL
CO LTD
ACITRETIN AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR CHONGQING
HUAPONT PHARMACEUTICAL CO LTD
24622 A III 2/4/2011 BESPAK DIV CONSORT MEDICAL PLC BESPAK BK357 & BK361 SHARED VALVE INFORMATION AS MANUFACTURED IN NORFOLK,
ENGLAND
24623 A III 2/3/2011 AMCOR FLEXIBLES BURGDORF GMBH TTS BACKING FILM M-PETP 12/ION 12/LDPE 40 (SPECIFICATION #178 INCLUDING
#SOP13209 AND #SOP79007) AS MANUFACTURED IN BURGDORF, SWITZERLAND
24624 A II 2/8/2011 MSN LABORATORIES LTD OLOPATADINE HYDROCHLORIDE [ROUTE CODE - "OH"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24625 A II 3/18/2011 LUPIN LTD CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24626 A II 2/11/2011 DERIVADOS QUIMICOS SAU CICLETANINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN
24627 A II 1/31/2011 NECTAR LIFESCIENCES LTD CEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN
PUNJAB, INDIA
24628 A II 1/30/2011 QINHUANGDAO ZIZHU PHARMACEUTICAL
CO LTD
MIFEPRISTONE AS MANUFACTURED IN HEBEI PROVINCE, CHINA
24629 A II 2/11/2011 HETERO DRUGS LTD RITONAVIR USP (FORM I), PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24630 A II 2/11/2011 SYMBIOTEC PHARMALAB LTD PREDNISOLONE HEMISUCCINATE USP AS MANUFACTURED IN INDORE (M.P), INDIA
24631 A II 2/4/2011 SYN TECH CHEM AND PHARM CO LTD METAXALONE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.
24632 I II 2/14/2011 ALKERMES GAINESVILLE LLC N1714 TABLETS AS MANUFACTURED IN KING OF PRUSSIA, PA
24633 A II 2/15/2011 CILAG AG NALOXONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN
SCHAFFHAUSEN, SWITZERLAND AND MOLINAZZO DI MONTEGGIO, SWITZERLAND FOR
CILAG AG
24634 A IV 2/12/2011 FLAMEL TECHNOLOGIES MEDUSA PGLUVE TYPE POLYMER AS MANUFACTURED IN PESSAC, FRANCE
24635 A III 2/7/2011 SRC MEDICAL INC VAGINAL APPLICATORS AS MANUFACTURED IN HANOVER, MA
24636 A II 2/7/2011 SMRUTHI ORGANICS LTD CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24637 I III 2/16/2011 MITSUI CHEMICALS AMERICA INC ADMER SE800 AS MANUFACTURED IN CHIBA, JAPAN FOR MITSUI CHEMICALS AMERICA
INC
24638 A II 3/31/2011 LUPIN LTD TELMISARTAN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24639 A II 3/11/2011 ARCH PHARMALABS LTD TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDE (ESUB) AS
MANUFACTURED IN MAHARASHTRA, INDIA
24640 A II 2/16/2011 DR REDDYS LABORATORIES LTD OMEPRAZOLE [PROCESS-II] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24641 A II 2/16/2011 HETERO DRUGS LTD ESOMEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24642 A II 2/15/2011 HOVIONE FARMACIENCIA SA SUMATRIPTAN USP AS MANUFACTURED IN LOURES, PORTUGAL
24643 A II 5/6/2011 ARCH PHARMALABS LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
24644 A II 2/16/2011 CADILA HEALTHCARE LTD OLMESARTAN MEDOXOMIL (ESUB)
Page 735
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24645 A II 2/15/2011 JINAN JINDA PHARMACEUTICAL CHEMISTRY
CO LTD
NITROFURANTOIN MACROCRYSTALS AS MANUFACTURED IN SHANDONG, CHINA
24646 A II 11/28/2012 APICORE LLC PERPHENAZINE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
24647 A II 2/18/2011 STERLING SPA FLUTICASONE FUROATE AS MANUFACTURED IN PERUGIA, ITALY
24648 A III 2/18/2011 IDEMITSU UNITECH CO LTD PLALOC M-700 AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN
24649 A II 2/14/2011 INKE SA ZOLMITRIPTAN AS MANUFACTURED IN BARCELONA, SPAIN
24650 A II 1/24/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
RAMIPRIL AS MANUFACTURED IN ZHEJIANG, CHINA
24651 A II 2/18/2011 STERLING SPA ETONOGESTREL AS MANUFACTURED IN PERUGIA, ITALY
24652 A II 2/18/2011 APTALIS PHARMATECH INC EUR-1098 AS MANUFACTURED IN VANDALIA, OHIO
24653 I II 1/27/2011 ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24654 A II 2/18/2011 SUVEN LIFE SCIENCES LTD LOSARTAN POTASSIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24655 A II 2/21/2011 EMCURE PHARMACEUTICALS LTD ESZOPICLONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24656 A II 2/21/2011 DR REDDYS LABORATORIES LTD ABACAVIR SULPHATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24657 A II 2/18/2011 YUNG ZIP CHEMICAL IND CO LTD METOPROLOL SUCCINATE AS MANUFACTURED IN TAIWAN, R.O.C.
24658 A III 2/18/2011 LAMINADOS FACARLYTE SA DE CV HEAT ACTIVATED AND ADHESIVE APPLIED PACKAGING MATERIALS AS MANUFACTURED
IN ESTADO DE MEXICO, MEXICO
24659 A II 2/18/2011 ESTEVE QUIMICA SA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TARRAGONA, SPAIN
24660 A II 2/21/2011 ZHEJIANG MEDICINE CO LTD XINCHANG
PHARMACEUTICAL FACTORY
LEVOFLOXACIN DS AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24661 A II 2/19/2011 QILU PHARMACEUTICAL CO LTD PALONOSETRON HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN
SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA
24662 I II 1/29/2011 QILU PHARMACEUTICAL CO LTD TAZOBACTAM SODIUM (STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE,
PEOPLE'S REPUBLIC OF CHINA
24663 A II 4/14/2011 TARO PHARMACEUTICAL INDUSTRIES LTD TERCONAZOLE USP (MICRONIZED) (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL
24664 A II 4/7/2011 SUN PHARMACEUTICAL INDUSTRIES LTD MESALAMINE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24665 A II 2/23/2011 HETERO LABS LTD IRBESARTAN (FORM A) PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24666 A II 2/23/2011 HETERO LABS LTD ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24667 A II 2/23/2011 HETERO DRUGS LTD MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24668 A II 2/24/2011 SIEGFRIED LTD NALOXONE HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN ZOFINGEN,
SWITZERLAND
24669 A II 2/25/2011 MYLAN LABORATORIES LIMITED ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24670 A II 2/25/2011 MYLAN LABORATORIES LTD BICALUTAMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, India
24671 A II 2/25/2011 ALEMBIC PHARMACEUTICALS LTD OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA
24672 A V 2/24/2011 BD DIAGNOSTIC SYSTEMS MICROPRO MICROBIAL DETECTION SYSTEM
24673 A III 2/18/2011 JAPAN VILENE CO LTD MEDICAL BACKING MATERIALS OF FILM LAMINATED NON-WOVEN AS MANUFACTURED IN
SHIGA, JAPAN
24674 A III 2/11/2011 YOUNG JIN CO LTD CONTAINER & CLOSURE AS MANUFACTURED IN KYUNGKI-DO, KOREA
24675 A II 2/15/2011 PHYTON BIOTECH LLC DOCETAXEL ANHYDROUS AS MANUFACTURED IN VANCOUVER, CANADA
24676 A III 2/14/2011 APTAR FRANCE SAS APTAR UNITDOSE POWDER AND BIDOSE POWDER SYSTEMS AS MANUFACTURED IN
CONGERS, NY AND EIGELTINGEN, GERMANY; AND LE VAUDREUIL, FRANCE
24677 A IV 3/11/2011 AUTHENTIX INC AUTHENTIX SECURITY MARKER AS MANUFACTURED IN ADDISON, TX
24678 A II 2/22/2011 PARABOLIC DRUGS LTD OXACILLIN SODIUM USP AS MANUFACTURED IN HARYANA, INDIA
Page 736
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24679 A II 2/25/2011 PARABOLIC DRUGS LTD CEPHALOTHIN SODIUM (STERILE) BUFFERED (USP) AS MANUFACTURED IN PUNJAB,
INDIA
24680 A II 2/23/2011 PCAS MIPRI AS MANUFACTURED IN ARAMON, FRANCE AND VILLENEUVE-LA-GARENNE,
FRANCE FOR PCAS
24681 A II 2/25/2011 EMCURE PHARMACEUTICALS LTD FELODIPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24682 A IV 2/25/2011 PHOSPHOLIPID GMBH PHOSAL 53 MCT AS MANUFACTURED IN COLOGNE, GERMANY
24683 A III 2/28/2011 ESSEL PROPACK LTD PLASTIC CAPS AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA
24684 A II 11/30/2010 MICRO LABS LTD INDIA ESCITALOPRAM OXALATE AS MANUFACTURED IN KARNATAKA, INDIA
24685 A II 3/17/2011 ALKEM LABORATORIES LTD DULOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24686 A II 11/26/2010 MICRO LABS LTD INDIA CELECOXIB AS MANUFACTURED IN KARNATAKA, INDIA
24687 A II 11/26/2010 MICRO LABS LTD INDIA TORSEMIDE USP AS MANUFACTURED IN KARNATAKA, INDIA
24688 A II 11/26/2010 MICRO LABS LTD INDIA LOSARTAN POTASSIUM USP AS MANUFACTURED IN KARNATAKA, INDIA
24689 A II 3/24/2011 SHILPA MEDICARE LTD CAPECITABINE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
24690 A II 5/11/2011 SHILPA MEDICARE LTD BICALUTAMIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
24691 A II 3/2/2011 SYMBIOTEC PHARMALAB LTD DEFLAZACORT MICRONIZED AS MANUFACTURED IN INDORE (M.P.), INDIA
24692 A II 3/1/2011 FRED HUTCHINSON CANCER RESCTR MANUFACTURE AND QUALITY CONTROL OF THE BC8-DOTA MONOCLONAL ANTIBODY
CONJUGATE (BC8-DOTA) AS MANUFACTURED IN SEATTLE, WA
24693 A II 2/28/2011 ESTEVE QUIMICA SA RILUZOLE AS MANUFACTURED IN TARRAGONA, SPAIN
24694 A II 2/25/2011 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R.
CHINA
24695 A IV 2/24/2011 HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED ARTIFICIAL CARAMEL FLAVOR # S-989 AS MANUFACTURED IN
PHILADELPHIA, PA
24696 A III 2/28/2011 ESSEL PROPACK LTD UNPRINTED AND PRINTED LAMINATES AS MANUFACTURED IN MAHARASHTRA, INDIA
24697 A IV 2/27/2011 SHOWA DENKO KK ADHERO AS MANUFACTURED IN YAMAGATA PREF., JAPAN FOR SHOWA DENKO KK
24698 A II 3/2/2011 DR REDDYS LABORATORIES LTD PALIPERIDONE PALMITATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24699 A III 1/17/2011 EMA PHARMACEUTICALS PACKAGING MATERIAL FOR 32 MM COMBINATED ALUMINIUM CAP AS MANUFACTURED IN
LAILLY EN VAL, FRANCE
24700 A II 3/3/2011 SRINI PHARMACEUTICALS LTD PREGABALIN AS MANUFACTURED IN CHOUTUPPAL AP, INDIA
24701 A II 3/1/2011 WANBURY LTD PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24702 P *** PENDING FILING REVIEW ***
24703 A II 5/12/2011 COSMA SPA TELMISARTAN (ESUB) AS MANUFACTURED IN BERGAMO, ITALY
24704 A III 3/3/2011 APTAR RADOLFZELL GMBH OPHTHALMIC DRUG DELIVERY SYSTEMS AS MANUFACTURED IN RADOLFZELL,
GERMANY AND EIGELTINGEN, GERMANY
24705 A II 3/29/2011 DR REDDYS LABORATORIES EU LTD LUBIPROSTONE (ESUB) AS MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM
24706 A II 2/28/2011 TOMITA PHARMACEUTICAL CO LTD USP CALCIUM CHLORIDE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
24707 A II 12/20/2010 TOMITA PHARMACEUTICAL CO LTD USP ZINC GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
24708 A II 12/20/2010 TOMITA PHARMACEUTICAL CO LTD USP CALCIUM GLUCONATE, MONOHYDRATE (ORAL DOSAGE FORM) AS MANUFACTURED
IN TOKUSHIMA, JAPAN
24709 A II 2/20/2011 HEC PHARM CO LTD CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN
HUBEI PROVINCE, P.R. CHINA
24710 A IV 3/4/2011 FINAR LTD TERTIARY BUTANOL HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA
24711 A IV 3/7/2011 DAVID MICHAEL AND CO INC MICHAELOK ARTIFICIAL STRAWBERRY FLAVOR #3095 AS MANUFACTURED IN
PHILADELPHIA, PA
24712 A II 3/9/2011 ALEMBIC PHARMACEUTICALS LTD WARFARIN SODIUM AMORPHOUS USP AS MANUFACTURED IN GUJARAT, INDIA
Page 737
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24713 A II 1/20/2011 NORTH CHINA PHARMACEUTICAL GROUP
SEMISYNTECH CO LTD
AMPICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P.R. CHINA
24714 A II 3/9/2011 ALEMBIC PHARMACEUTICALS LTD MEXILETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
24715 A II 3/31/2011 LUPIN LTD RITONAVIR - COPOVIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24716 A II 3/8/2011 HANGZHOU ZHONGMEI HUADONG
PHARMACEUTICAL CO LTD
MUPIROCIN CALCIUM AS MANUFACTURED IN HANGZHOU, CHINA
24717 A II 3/31/2011 GLENMARK GENERICS LTD VORICONAZOLE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
24718 A II 3/21/2011 JUBILANT LIFE SCIENCES LTD FAMPRIDINE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24719 A II 3/26/2011 JUBILANT LIFE SCIENCES LTD CYCLOBENZAPRINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MYSORE DIST.,
INDIA
24720 A II 3/25/2011 TORRENT PHARMACEUTICALS LTD TELMISARTAN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24721 A II 4/1/2011 TORRENT PHARMACEUTICALS LTD MONTELUKAST SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24722 A II 3/8/2011 ALCHYMARS ICM SM PRIVATE LTD MAFENIDE ACETATE USP AS MANUFACTURED IN TAMILNADU, INDIA
24723 A II 3/4/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DAPTOMYCIN AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF
CHINA FOR ZHEJIANG HISUN PHARMACEUTICAL CO., LTD.
24724 A II 1/18/2011 TEVA PHARMACEUTICAL INDUSTRIES LTD VALSARTAN AS MANUFACTURED IN UTTAR PRADESH, INDIA AND MADHYA PRADESH,
INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
24725 A II 3/5/2011 RESONANCE LABORATORIES PVT LTD CLIDINIUM BROMIDE (CLDB) AS MANUFACTURED IN BANGALORE, INDIA
24726 A II 3/1/2011 VITAL LABORATORIES PVT LTD COLCHICINE USP AS MANUFACTURED IN GUJARAT, INDIA
24727 A II 3/10/2011 3M DRUG DELIVERY SYSTEMS BA058-SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (BA058-SMTS) COATING AND
DRYING PROCESS FOR THE FINISHED DRUG PRODUCT AS MANUFACTURED IN ST. PAUL,
MN
24728 A II 2/28/2011 FIS FABBRICA ITALIANA SINTETICI SPA CLOBAZAM AS MANUFACTURED IN VICENZA, ITALY
24729 A IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4566.CP PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24730 A IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3964.2P PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24731 A IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4554.CP PHA MILK FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
24732 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3514.2P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24733 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4582.2P PHA SOUR CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24734 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4568.1G PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24735 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.4262.2L PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24736 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4570.3P PHA PASSION FRUIT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY
AND TORINO (TO), ITALY
24737 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4564.2P PHA GRAPE FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24738 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3748.UW PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24739 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4563.UL PHA CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
Page 738
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24740 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4557.1G PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY
AND TORINO (TO), ITALY
24741 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3754.1P PHA SPEARMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24742 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4561.1P PHA BLACKCURRANT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY
AND TORINO (TO), ITALY
24743 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3536.1P PHA LIME FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
(TO), ITALY
24744 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
20.4579.1P PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY
AND TORINO (TO), ITALY
24745 A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS
ITALIA SPA
58.3520.1P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND
TORINO (TO), ITALY
24746 A II 3/11/2011 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) [PROCESS-3] AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
24747 A II 3/10/2011 SINTENOVO SA DE CV MONTELUKAST SODIUM AS MANUFACTURED IN MORELOS, MEXICO
24748 A II 3/10/2011 NECTAR LIFESCIENCES LTD CEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN
PUNJAB, INDIA
24749 A II 3/10/2011 HENAN LIHUA PHARMACEUTICAL CO LTD PREDNISONE AS MANUFACTURED IN HENAN, CHINA
24750 A II 3/14/2011 INDUSTRIALE CHIMICA SRL BUMETANIDE AS MANUFACTURED IN SARONNO (VARESSE), ITALY
24751 A II 3/10/2011 MARUHA NICHIRO CORP SODIUM HYALURONATE FH AND SODIUM HYALURONATE FL AS MANUFACTURED IN
TOCHIGI-PREF, JAPAN
24752 A II 3/8/2011 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
IRBESARTAN API AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
24753 A II 2/28/2011 MICRO LABS LTD INDIA DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA
24754 A II 2/1/2011 ALEMBIC PHARMACEUTICALS LTD AZITHROMYCIN MONOHYDRATE USP (PROCESS-II) AS MANUFACTURED IN GUJARAT,
INDIA
24755 A II 3/10/2011 CHANGZHOU PHARMACEUTICAL FACTORY ALISKIREN HEMIFUMARATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
24756 A II 3/31/2011 UNICHEM LABORATORIES LTD ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN RAIGAD, INDIA
24757 A II 3/15/2011 SRINI PHARMACEUTICALS LTD LEVETIRACETAM USP AS MANUFACTURED IN HYDERABAD AP, INDIA
24758 P *** PENDING FILING REVIEW ***
24759 A IV 3/14/2011 HENKEL CORP DURO-TAK 87-6911 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
24760 A II 3/16/2011 DSM FINE CHEMICALS AUSTRIA NEOSTIGMINE METHYLSULFATE AS MANUFACTURED IN LINZ, AUSTRIA
24761 A II 3/7/2011 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA
24762 A II 3/15/2011 AARTI INDUSTRIES LTD DIFLUNISAL AS MANUFACTURED IN MAHARASHTRA, INDIA
24763 A II 3/15/2011 AIR LIQUIDE ELECTRONICS US LP NITRIC OXIDE AS MANUFACTURED IN MORRISVILLE, PA
24764 A II 3/15/2011 MACLEODS PHARMACEUTICALS LTD TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN GUJARAT, INDIA
24765 A II 3/28/2011 JUBILANT LIFE SCIENCES LTD SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
24766 I II 3/28/2011 IPCA LABORATORIES LTD TRAMADOL HYDROCHLORIDE (YT3 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24767 A II 4/20/2011 IPCA LABORATORIES LTD CLOPIDOGREL BISULFATE USP (XC4 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA
PRADESH, INDIA
24768 I II 4/26/2011 IPCA LABORATORIES LTD FLUCONAZOLE (G3 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24769 I II 6/27/2012 IPCA LABORATORIES LTD RITALINIC ACID (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24770 A II 3/17/2011 HETERO LABS LTD CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 739
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24771 A III 3/10/2011 AVI GLOBAL PLAST PVT LTD CALENDARED RIGID PVC FILM FOR BLISTER PACKAGING AS MANUFACTURED IN DAMAN,
INDIA
24772 A V 1/31/2011 ROTEM INDUSTRIES LTD CASSETTE FOR PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE
TRACERLAB MXFDG SYNTHESIS UNIT AS MANUFACTURED BY ROTEM INDUSTRIES LTD.
IN MISHOR YAMIN, ISRAEL
24773 A III 3/10/2011 FUTURISTIC PACKAGING PRIVATE LTD ALUMINIUM BLISTER FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA
24774 A III 3/10/2011 FUTURISTIC PACKAGING PRIVATE LTD ALUMINIUM STRIP FOIL (LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA
24775 A II 3/16/2011 SMRUTHI ORGANICS LTD CIPROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24776 A III 3/8/2011 CHARTER NEX FILMS INC NEX 1506 MONOLAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN
TURNERS FALLS, MA AND MILTON, WI
24777 I II 3/19/2011 EMCURE PHARMACEUTICALS LTD THIAMINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24778 A II 3/22/2011 HETERO DRUGS LTD MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24779 A III 3/22/2011 DOW CHEMICAL CO VINYL ACETATE/VINYL CHLORIDE CO-POLYMER FORMULATIONS AS MANUFACTURED IN
ELK GROVE VILLAGE, IL
24780 A IV 3/18/2011 NIPPON FINE CHEMICAL CO LTD CHOLESTEROL HP AS MANUFACTURED IN HYOGO, JAPAN AND SHIZUOKA, JAPAN FOR
NIPPON FINE CHEMICAL CO LTD
24781 A II 6/23/2011 WOCKHARDT LTD PRAMIPEXOLE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24782 A II 3/23/2011 TEVA PHARMACEUTICALS INDUSTRIES LTD ERGOTAMINE TARTRATE AS MANUFACTURED IN KOMAROV, CZECH REPUBLIC FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
24783 A III 3/22/2011 TOYO INK MFG CO LTD ELBIMA Z117 AS MANUFACTURED IN TOKYO, JAPAN
24784 A II 3/23/2011 EMCURE PHARMACEUTICALS LTD PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
24785 A IV 1/6/2011 SYMRISE AG 207420 STRAWBERRY FLAVOR #68998 AS MANUFACTURED IN HOLZMINDEN GERMANY
24786 A III 3/17/2011 ALPHAPET INC PREFORMANCE PET 1708CC(A) AS MANUFACTURED IN DECATUR, AL
24787 A II 3/22/2011 PARABOLIC DRUGS LTD CEFTAZIDIME FOR INJECTION (USP) AS MANUFACTURED IN PUNJAB, INDIA
24788 A II 3/18/2011 FORMOSA LABORATORIES INC LAPATINIB DITOSYLATE AS MANUFACTURED IN TAOYUAN, TAIWAN
24789 A II 3/22/2011 RA CHEM PHARMA LTD 2-(2,3-DICHLOROPHENYL) METHYLENE HYDRAZINE CARBOXIMID AMIDINE AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
24790 A II 3/25/2011 ALEMBIC PHARMACEUTICALS LTD LINEZOLID AS MANUFACTURED IN GUJARAT, INDIA
24791 A II 3/25/2011 HOVIONE FARMACIENCIA SA FLUTICASONE PROPIONATE INHALATION GRADE AS MANUFACTURED IN LOURES,
PORTUGAL
24792 A III 3/25/2011 3M DRUG DELIVERY SYSTEMS BECLOMETHASONE DIPROPIONATE HFA NASAL AEROSOL VALVE AS MANUFACTURED IN
LANCASHIRE, GREAT BRITAIN FOR 3M DRUG DELIVERY SYSTEMS
24793 A II 3/15/2011 KYONGBO PHARMACEUTICAL CO LTD CEFOTAXIME SODIUM, STERILE API AS MANUFACTURED IN CHUNGCHEONG NAM-DO,
REP OF KOREA
24794 A II 3/28/2011 EMCURE PHARMACEUTICALS LTD DOLASETRON MESYLATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24795 A II 3/24/2011 HENAN LIHUA PHARMACEUTICAL CO LTD PREDNISOLONE AS MANUFACTURED IN HENAN, CHINA
24796 A II 3/29/2011 ALEMBIC PHARMACEUTICALS LTD WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN GUJARAT, INDIA
24797 A II 3/29/2011 DIVIS LABORATORIES LTD VALSARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24798 A II 3/23/2011 PERRIGO API LTD PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN SHANDONG KEYUAN, CHINA
FOR PERRIGO API LTD
24799 A II 1/8/2011 SRI VYJAYANTHI LABS PVT LTD 2,3,4,5-BIS-O-(1-METHYLETHYLIDENE)-D-FRUCTOPYRANOSE AS MANUFACTURED IN A.P.,
INDIA
24800 A II 6/27/2011 JUBILANT LIFE SCIENCES LTD QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
24801 A III 3/24/2011 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-PINK PE3M176130 AS MANUFACTURED IN MALMO, SWEDEN
Page 740
4Q2012 2Q2014EXCEL
24802 A IV 3/31/2011 FONA INTERNATIONAL INC 862.0194U FONATECH LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
24803 A IV 3/31/2011 FONA INTERNATIONAL INC 828.078 N-C CITRUS FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
24804 A IV 3/31/2011 FONA INTERNATIONAL INC 828.112 N-C CITRUS FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL
24805 A III 4/1/2011 POLYONE CORP CC10029299WE AS MANUFACTURED IN GLENDALE, AZ AND ELK GROVE VILLAGE, IL
24806 A III 4/1/2011 POLYONE CORP CC10075198BG AS MANUFACTURED IN TOSSIAT, FRANCE FOR POLYONE CORP
24807 A III 3/29/2011 AMERICHEM INC 61644-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH
24808 A III 3/31/2011 REXAM HEALTHCARE OFFRANVILLE SAS EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE
24809 A IV 3/31/2011 JRS PHARMA GMBH AND CO KG SODIUM STARCH GLYCOLATE, PH. EUR, NF, JP AS MANUFACTURED IN GUJARAT, INDIA
FOR JRS PHARMA GMBH & CO. KG
24810 A II 3/28/2011 MACLEODS PHARMACEUTICALS LTD CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA
24811 A II 3/30/2011 DR REDDYS LABORATORIES LTD IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24812 A II 4/1/2011 RICHTER THEMIS MEDICARE I PVT LTD FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA
24813 A II 3/31/2011 DR REDDYS LABORATORIES LTD PANTOPRAZOLE SODIUM USP [PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
24814 A II 3/30/2011 DEVATS INDIA PRIVATE LTD NIMORAZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA
24815 A II 4/1/2011 MSN LABORATORIES LTD DEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE: "DP"] AS MANUFACTURED
ANDHRA PRADESH, INDIA
24816 A II 3/28/2011 PIRAMAL ENTERPRISES LTD QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24817 A II 3/31/2011 DR REDDYS LABORATORIES LTD ESLICARBAZEPINE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24818 A II 3/31/2011 DR REDDYS LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE (CRYSTALLINE) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24819 A II 4/4/2011 MERCK AND CIE 1, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC) AS MANUFACTURED IN
SCHAFFHAUSEN, SWITZERLAND
24820 A IV 4/1/2011 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
SHEFFCOAT COATING SYSTEMS AS MANUFACTURED IN NORWICH, NY
24821 A II 3/31/2011 DR REDDYS LABORATORIES LTD NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24822 A II 3/30/2011 DR REDDYS LABORATORIES LTD FEBUXOSTAT AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24823 A II 3/30/2011 DR REDDYS LABORATORIES LTD BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24824 A II 5/31/2011 NATCO PHARMA LTD IBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
24825 A II 4/12/2011 GLENMARK GENERICS LTD EZETIMIBE (PROCESS II) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
24826 A II 3/21/2011 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
PENICILLIN G POTASSIUM (NON-STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R.
CHINA
24827 A II 4/5/2011 MSN LABORATORIES LTD ZILEUTON USP [ROUTE CODE -ZN] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24828 A II 4/5/2011 MSN LABORATORIES LTD SALMETEROL XINAFOATE [ROUTE CODE - SX] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
24829 A II 3/31/2011 DR REDDYS LABORATORIES LTD FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24830 A II 4/5/2011 ALEMBIC PHARMACEUTICALS LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
24831 A II 4/1/2011 DR REDDYS LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE (AMORPHOUS) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24832 A II 4/6/2011 ALEMBIC PHARMACEUTICALS LTD ILOPERIDONE AS MANUFACTURED IN GUJARAT, INDIA
24833 I II 4/6/2011 ALEMBIC PHARMACEUTICALS LTD TOPIRAMATE USP AS MANUFACTURED IN GUJARAT, INDIA
24834 A II 3/28/2011 MICRO LABS LTD INDIA IRBESARTAN USP AS MANUFACTURED IN KARNATAKA, INDIA
24835 A II 4/7/2011 MSN PHARMACHEM PVT LTD APREPITANT (ROUTE CODE - AP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 741
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24836 A III 3/25/2011 BESPAK DIV CONSORT MEDICAL PLC BK640 NASAL INTERGRATED DOSE COUNTER AS MANUFACTURED IN NORFOLK, UNITED
KINGDOM
24837 A II 3/31/2011 QILU TIANHE PHARMACEUTICAL CO LTD ZIPRASIDONE HYDROCHLORIDE (NON - STERILE API) AS MANUFACTURED IN SHANDONG
PROVINCE, CHINA
24838 A II 3/26/2011 TAI HENG INDUSTRY CO LTD IMATINIB MESYLATE AS MANUFACTURED IN SHANGHAI CHINA
24839 A IV 4/8/2011 MOLKEREI MEGGLE WASSERBURG GMBH
AND CO KG
CAPSULAC 60 INH US AS MANUFACTURED IN WESSERBURG, GERMANY
24840 A IV 4/11/2011 FONA INTERNATIONAL INC 803.0115U N-C RED APPLE TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL
24841 A IV 4/11/2011 FONA INTERNATIONAL INC 825.441 N-C WILD CHERRY FLAVOR, ART AS MANUFACTURED IN GENEVA ILLINOIS
24842 A IV 4/11/2011 FONA INTERNATIONAL INC 862.0085U N-C LEMONADE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA ILLINOIS
24843 A III 4/11/2011 FORMOSA PLASTICS CORP PP DIV, TAIWAN. YUNGSOX PROPYLENE RESINS AS MANUFACTURED IN KAOHSIUNG CITY, TAIWAN R.O.C.
FOR FORMOSA PLASTICS CORPORATION PP DIVISION, TAIWAN
24844 I II 4/12/2011 ALEMBIC PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN GUJARAT, INDIA
24845 A III 4/1/2011 POLYONE CORP CC10029299WE AS MANUFACTURED IN GLENDALE, AZ AND ELK GROVE VILLAGE, IL
24846 A II 9/30/2011 MALLINCKRODT INC HYDROCODONE POLISTIREX FOR SUSPENSION, CODE 7490 AS MANUFACTURED IN ST.
LOUIS, MO
24847 A II 4/8/2011 ACEBRIGHT INDA PHARMA PRIVATE LTD EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN KARNATAKA,
INDIA
24848 A II 9/30/2011 MALLINCKRODT INC CHLORPHENIRAMINE POLISTIREX FOR SUSPENSION, CODE 7480 AS MANUFACTURED IN
ST. LOUIS, MO
24849 A II 5/19/2011 MITSUBISHI TANABE PHARMA CORP AVANAFIL (ESUB) AS MANUFACTURED IN YAMAGUCHI, JAPAN
24850 A IV 2/16/2011 UNGERER AND CO NATURAL AND ARTIFICIAL ORANGE FLAVOR FS-10783 AS MANUFACTURED IN
BETHLEHEM, PA FOR UNGERER & COMPANY.
24851 A IV 2/16/2011 UNGERER AND CO ARTIFICIAL GRAPE FLAVOR FT - 2968 AS MANUFACTURED IN BETHLEHEM, PA FOR
UNGERER & COMPANY
24852 A II 5/5/2011 CIPLA LTD TENOFOVIR DISOPROXIL FUMARATE PROCESS B (ESUB) AS MANUFACTURED PUNE
(MAHARASHTRA) INDA
24853 A IV 2/16/2011 UNGERER AND CO NATURAL BLUEBERRY WONF FLAVOR FT - 2967 AS MANUFACTURED IN BETHLEHEM, PA
FOR UNGERER & Company
24854 A II 6/14/2011 DR REDDYS LABORATORIES LTD DOCETAXEL ANHYDROUS (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA
24855 A II 4/12/2011 BACHEM SA TRANDOLAPRIL AS MANUFACTURED IN VIONNAZ, SWITZERLAND
24856 A II 4/12/2011 SYMED LABS LTD PHENTERMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24857 A II 4/7/2011 SMRUTHI ORGANICS LTD ENROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24858 A II 4/5/2011 STERLING BIOTECH LTD DOXORUBICIN HYDROCHLORIDE(API) AS MANUFACTURED IN GUJARAT, INDIA FOR
STERLING BIOTECH LIMITED
24859 A II 4/7/2011 STERLING BIOTECH LTD LOVASTATIN(API) AS MANUFACTURED IN GUJARAT, INDIA FOR STERLING BIOTECH
LIMITED
24860 A V 4/8/2011 BIOLUMIX INC MICROBIOLOGICAL RAPID METHOD TO DETECTION AND ENUMERATION OF
MICROORGANISMS IN PHARMACEUTICAL PRODUCTS AS LOCATED IN ANN ARBOR, MI
24861 A III 4/11/2011 HOLLAND COLOURS AMERICAS INC COLOR CONCENTRATES FOR PET AS MANUFACTURED IN RICHMOND, IN
24862 A II 7/5/2011 APICORE LLC PENTOSTATIN (ESUB) AS MANUFACTURED IN SOMERSET, NJ
24863 A II 4/6/2011 ESTEVE QUIMICA SA ESZOPICLONE AS MANUFACTURED IN BANYERES DEL PENEDES(TARRAGONA), SPAIN
FOR ESTEVE QUIMICA, S. A.
24864 A II 4/18/2011 AMBIOPHARM INC EPTIFIBATIDE, NON-STERILE, BULK DRUG(API) AS MANUFACTURED IN NORTH AUGUSTA,
SC AND SHANGHAI, CHINA FOR AMBIOPHARM INC
Page 742
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24865 A III 4/1/2011 ADHESIVES RESEARCH INC A4435 (EC-18B ADHESIVE) AS MANUFACTURED IN GLEN ROCK, PA
24866 A III 4/1/2011 ADHESIVES RESEARCH INC A4436(EC-23B ADHESIVE) AS MANUFACTURED IN GLEN ROCK , PA
24867 A III 4/1/2011 ADHESIVES RESEARCH INC A4437(MA-80 ADHESIVE) AS MANUFACTURED IN GLEN ROCK, PA
24868 A II 5/2/2011 IPCA LABORATORIES LTD ETODOLAC (ED6 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24869 A II 4/15/2011 MACLEODS PHARMACEUTICALS LTD ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT, INDIA FOR MACLEODS
PHARMACEUTICALS LIMITED
24870 A III 4/4/2011 FIBERTEX NONWOVENS AS FIBERTEX TERCIE 60 AS MANUFACTURED IN SVITAVY,CZECH REPUBLIC
24871 A II 4/18/2011 HETERO DRUGS LTD SOLIFENACIN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24872 A II 4/15/2011 EMCURE PHARMACEUTICALS LTD SEVELAMER HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN MAHARASHTRA,
INDIA FOR EMCURE PHARMACEUTICALS LIMITED
24873 A II 4/18/2011 HETERO LABS LTD VALSARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24874 A II 4/15/2011 PIRAMAL HEALTHCARE CANADA LTD TAZAROTENE AS MANUFACTURED IN ONTARIO, CANADA
24875 A II 4/15/2011 AMINO CHEMICALS LTD DEXLANSOPRAZOLE ANHYDROUS AS MANUFACTURED IN MARSA, MALTA
24876 A II 4/15/2011 SCI PHARMTECH INC ALLOPURINOL AS MANUFACTURED IN TAOYUAN, TAIWAN
24877 A II 5/9/2011 ARCH PHARMALABS LTD ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6-{2[2-(4-FLUOROPHENYL)-5-(1-METHYLETHYL)-3-
PHENYL-4[(PHENYLAMINO) CARBONYL]-1 H-PYRROL-1-YL]ETHYL}-2,2-DIMETHYL-1,3-
DIOXAN-4-ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24878 A III 4/20/2011 RPC FORMATIC GMBH MOUTHPIECE WITH ACTUATION INDICATOR AS MANUFACTURED IN MELLRICHSTADT,
GERMANY
24879 A II 4/21/2011 FDC LTD MICONAZOLE USP AS MANUFACTURED IN MAHARASHTRA STATE, INDIA
24880 I II 7/29/2011 RELIANCE LIFE SCIENCES PVT LTD DUTASTERIDE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
24881 A II 4/22/2011 MEGAFINE PHARMA P LTD CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED
IN DIST. NASHIK, INDIA
24882 A II 7/18/2011 AMI ORGANICS PVT LTD 1-(3-CHLORO PHENYL)-4-(3-CHLOROPROPYL) PIPERAZINE HYDROCHLORIDE AS
MANUFACTURED IN GUJURAT, INDIA
24883 I II 11/21/2011 RELIANCE LIFE SCIENCES PVT LTD NANDROLONE DECANOATE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA
24884 A II 5/6/2011 ALKEM LABORATORIES LTD RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
24885 A II 4/12/2011 CHONGQING ZEIN PHARMACEUTICAL CO
LTD
ORLISTAT AS MANUFACTURED IN CHONGQING, CHINA
24886 A II 4/25/2011 HETERO LABS LTD LETROZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24887 A II 4/25/2011 ANQUI LUAN PHARMACEUTICAL CO LTD ACETAMINOPHEN DC90-3 SD AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF
CHINA
24888 A V 4/21/2011 COOK PHARMICA LLC STERILE FILLING OPERATION AS LOCATED IN BLOOMINGTON, IN
24889 A II 4/26/2011 ERREGIERRE SPA MESALAMINE USP - PH.EUR. (HIGH DENSITY) AS MANUFACTURED IN BERGAMO, ITALY
24890 A II 4/22/2011 FRESENIUS KABI ANTI INFECTIVES SRL CEPHAPIRIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE, ITALY
24891 A III 4/25/2011 TOPPAN PRINTING CO LTD HP-4, PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN
FUKUOKA, JAPAN
24892 A II 4/18/2011 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
CEFOTAXIME SODIUM STERILE AS MANUFACTURED IN HEBEI, CHINA
24893 A II 4/26/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC
OF CHINA
24894 A III 4/28/2011 HUDSON COLOR CONCENTRATES AMBER HC72646PVC AS MANUFACTURED IN LEOMINSTER, MA
24895 P *** PENDING FILING REVIEW ***
24896 A II 8/16/2011 EPHAR BIOLOGICAL AND CHEMICAL CO LTD ATORVASTATIN CALCIUM (API) (ESUB) AS MANUFACTURED IN ANHUI PROVINCE, P.R.
CHINA
Page 743
4Q2012 2Q2014EXCEL
24897 P *** PENDING FILING REVIEW ***
24898 A II 4/29/2011 MSN PHARMACHEM PVT LTD RANOLAZINE[ROUTE CODE: "RL"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24899 A II 4/5/2011 VINDHYA PHARMA INDIA PVT LTD N-METHYL FLUOXETINE OXALATE(NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
24900 A III 4/25/2011 MEENAKSHI FOILS SLITTED & PRINTED FOILS AND SLITTED PVDC COATED PVC FILMS" AS MANUFACTURED
IN DAMAN, INDIA
24901 A II 4/20/2011 FIS FABBRICA ITALIANA SINTETICI SPA ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN VICENZA, ITALY
24902 A II 8/27/2012 CF PHARMA LTD CISATRACURIUM BESYLATE VERSION FA1 AS MANUFACTURED IN BUDAPEST, HUNGARY
24903 A II 4/29/2011 JIANGSU HENGRUI MEDICINE CO LTD SEVOFLURANE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU
PROVINCE, P. R. CHINA
24904 A III 4/29/2011 POLYONE CORP EM1002025410 AS MANUFACTURED IN AVON LAKE, OHIO
24905 A II 5/2/2011 SMS PHARMACEUTICALS LTD ELETRIPTAN HYDROBROMIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24906 A II 4/18/2011 YONSUNG FINE CHEMICALS CO LTD BIMATOPROST AS MANUFACTURED IN GYEONGGI-DO, KS
24907 A II 4/18/2011 YONSUNG FINE CHEMICALS CO LTD TRAVOPROST AS MANUFACTURED IN GYCONGGI-DO, REPUBLIC OF KOREA
24908 A IV 4/27/2011 UNGERER AND CO NATURAL AND ARTIFICIAL LEMON LIME FLVP FT-867 AS MANUFACTURED IN BETHLEHEM,
PA
24909 A III 4/29/2011 AMPACET CORP 101736 AB PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,LA,
CARTERSVILLE, GA, HEATH, OH
24910 A IV 1/12/2011 MINGTAI CHEMICAL CO LTD CROSCARMELLOSE SODIUM NF(PROCESS II) AS MANUFACTURED IN TAIWAN, R. O. C.
24911 A III 5/3/2011 SABIC EUROPE SABIC PP PCGR02 00900 AS MANUFACTURED IN THE NETHERLANDS
24912 A II 2/13/2012 VALDEPHARM ETHINYL ESTRADIOL (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE
24913 A II 5/25/2011 VALDEPHARM NORETHINDRONE ACETATE (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE
24914 A II 4/30/2011 CADILA HEALTHCARE LTD PALIPERIDONE API AS MANUFACTURED IN GUJARAT, INDIA
24915 A II 5/2/2011 POLYDRUG LABORATORIES PVT LTD LOSARTAN POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA
24916 A II 5/4/2011 MSN PHARMACHEM PVT LTD NEBIVOLOL HYDROCHLORIDE[ROUTE CODE: "NH"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
24917 A II 5/2/2011 SCI PHARMTECH INC CLINDAMYCIN PALMITATE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN, TAIWAN
24918 A II 7/30/2011 EMCURE PHARMACEUTICALS LTD ESOMEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24919 A II 4/8/2011 HUBEI YITAI PHARMACEUTICAL CO LTD ACYCLOVIR(NON-STERILE,BULK FORM) AS MANUFACTURED IN HUBEI, P. R. CHINA
24920 A II 4/8/2011 HUBEI YITAI PHARMACEUTICAL CO LTD VALACYCLOVIR HYDROCHLORIDE(NON-STERILE, BULK FORM) AS MANUFACTURED IN
HUBEI, P. R. CHINA
24921 A II 5/28/2011 CONCORD BIOTECH LTD TEMSIROLIMUS (ESUB) AS MANUFACTURED IN AHMEDABAD, INDIA
24922 A II 6/8/2011 EMCURE PHARMACEUTICALS LTD BICALUTAMIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
24923 A II 5/2/2011 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
OMEPRAZOLE (C-015) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
24924 A II 5/2/2011 MOEHS IBERICA SL RABEPRAZOLE SODIUM AS MANUFACTURED IN RUBI(BARCELONA), SPAIN
24925 A IV 5/5/2011 LIPOID GMBH LIPOID PG 16:O/16:0 (DPPG-NA) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY
24926 A IV 5/4/2011 JRS PHARMA GMBH AND CO KG HYPROMELLOSE USP AS MANUFACTURED IN ZACAPU, MEXICO
24927 A II 5/2/2012 MALLINCKRODT INC BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210 (ESUB) AS MANUFACTURED IN ST.
LOUIS, MO
24928 A II 5/2/2012 MALLINCKRODT INC BUPRENORPHINE BASE EP, CODE 3205(ESUB) AS MANUFACTURED IN ST. LOUIS, MO
24929 A II 5/9/2011 ZACH SYSTEM SPA BOSENTAN MONOHYDRATE AS MANUFACTURED IN TAMIL NADU, INDIA
Page 744
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24930 A III 4/8/2011 BOREALIS AG BORMED RD804CF AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG
24931 A III 4/8/2011 BOREALIS AG BORMED TD109CF AS MANUFACTURED IN BERINGEN, BELGIUM FOR BOREALIS AG
24932 A II 5/10/2011 SYMED LABS LTD ILOPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24933 A II 5/11/2011 CHEMI SPA EPTIFIBATIDE AS MANUFACTURED IN MILAN, ITLAY AND FROSINONE, ITALY
24934 A II 5/12/2011 TEVA PHARMACEUTICAL INDUSTRIES LTD ACYCLOVIR AS MANUFACTURED IN HANGZHOU, P.R. CHINA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
24935 A II 5/10/2011 ZHEJIANG JIANGBEI PHARMACEUTICAL CO
LTD
SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN ZHEJIANG, CHINA
24936 A II 5/12/2011 ULKAR KIMYA SANAYI VE TICARET AS ETODOLAC AS MANUFACTURED IN TEKIRDAG, TURKEY
24937 A II 5/12/2011 ULKAR KIMYA SANAYI VE TICARET AS ARIPIPRAZOLE AS MANUFACTURED IN TEKIRDAG, TURKEY
24938 I III 1/19/2011 HUAYI ISOTOPES CORP VACUUM STERILE VIALS AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
24939 A II 5/6/2011 SCI PHARMTECH INC DULOXETINE HYDROCHLORIDE (FROM (S)-MMAA) AS MANUFACTURED IN TAOYUAN,
TAIWAN
24940 A IV 5/16/2011 FONA INTERNATIONAL INC 875.0040U N-C ENCAPSULATED MENTHOL AS MANUFACTURED IN GENEVA, IL
24941 A II 5/11/2011 FRESENIUS KABI ANTI INFECTIVES SRL BUFFERED OXACILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO) ITALY
24942 A II 5/17/2011 GLOCHEM INDUSTRIES LTD AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24943 A II 5/17/2011 HETERO LABS LTD EFAVIRENZ (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24944 A II 8/23/2011 SHILPA MEDICARE LTD BORTEZOMIB (ESUB) AS MANUFACTURED IN KARNATAKA INDIA
24945 A II 6/1/2011 UNIMARK REMEDIES LTD ARMODAFINIL AS MANUFACTURED IN GUJARAT INDIA
24946 A II 10/20/2011 CHEMWERTH INC TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA FOR CHEMWERTH INC.
24947 A II 5/18/2011 HETERO LABS LTD LAMIVUDINE, USP (FORM I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24948 A II 10/13/2011 JUBILANT LIFE SCIENCES LTD ROPIVACAINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
24949 A II 11/3/2011 APICORE LLC CEVIMELINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR
APICORE LLC
24950 A III 5/26/2011 SELECTIVE COATINGS AND INKS INC SCI BOND HEAT SEAL COATINGS AS MANUFACTURED IN FARMINGDALE, NJ
24951 A IV 5/16/2011 JRS PHARMA GMBH AND CO KG CROSCARMELLOSE SODIUM, PH.EUR., NF, JP AS MANUFACTURED IN GUJARAT, INDIA
FOR JRS PHARMA GMBH & CO. KG
24952 A IV 5/12/2011 UNGERER AND CO NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR FU-3869 AS MANUFACTURED IN
BETHLEHEM, PA
24953 A III 5/16/2011 SAM A ALUMINIUM CO LTD CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO, KOREA
24954 A II 5/6/2011 PIRAMAL ENTERPRISES LTD TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24955 A II 10/13/2011 JUBILANT LIFE SCIENCES LTD ZIPRASIDONE HYDROCHLORIDE USP(ESUB) AS MANUFACTURED IN MYSORE, INDIA
24956 A II 5/17/2011 SM BIOMED SDN BHD ERYTHROMYCIN BASE AS MANUFACTURED IN KEDAH DARUL AMAN, MALAYSIA
24957 A III 5/17/2011 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEMS FOR 'N' DESIGN AS MANUFACTURED IN
BANGALORE, INDIA
24958 A II 6/6/2011 CTX LIFE SCIENCES PVT LTD LAMOTRIGINE USP (ESUB)AS MANUFACTURED IN GUJARAT, INDIA
24959 A II 5/2/2011 SHANGHAI DONGYUE BIOCHEM CO LTD CLOPIDOGREL BISULFATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR
SHANGHAI DONGYUE BIOCHEM CO., LTD
24960 A II 5/5/2011 AESICA PHARMACEUTICALS LTD PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN
NORTHUMBERLAND, UK
24961 A IV 5/9/2011 HENKEL CORP DURO-TAK 87-6908 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
Page 745
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24962 A II 5/5/2011 SYN TECH CHEM AND PHARM CO LTD DICLOFENAC EPOLAMINE AS MANUFACTURED IN TAINAN CITY, TAIWAN
24963 A II 5/18/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD TAZOBACTAM AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF
CHINA
24964 A II 5/20/2011 SANDOZ GMBH TEMSIROLIMUS AS MANUFACTURED IN TYROL, AUSTRIA
24965 A II 7/6/2011 IPCA LABORATORIES LTD TRIAMTERENE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
24966 A IV 5/18/2011 PHOSPHAGENICS LTD TOCOPHEROL PHOSPHATES(TPH) NOVEL DELIVERY PLATFORM AS MANUFACTURED IN
VICTORIA, AUSTRALIA
24967 A II 4/29/2011 SOUTHWEST SYNTHETIC PHARMACEUTICAL
CO LTD
SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN CHONGQING, P. R. CHINA
24968 A II 10/14/2011 APICORE LLC NADOLOL, USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
24969 A II 8/27/2012 CF PHARMA LTD CISATRACURIUM BESYLATE VERSION FB1 AS MANUFACTURED IN BUDAPEST, HUNGARY
24970 A II 5/24/2011 RANBAXY LABORATORIES LTD ATAZANAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA FOR RANBAXY
LABORATORIES LIMITED
24971 A II 5/16/2011 PERRIGO API LTD IMATINIB MESYLATE ALPHA FORM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL, A.P.,
INDIA FOR CHEMAGIS LTD
24972 A V 5/7/2011 MICROTROL STERILISATION SERVICES PVT
LTD
ETHYLENE OXIDE STERILISATION AS MANUFACTURED IN MAHARASHTRA, INDIA
24973 A II 5/25/2011 HETERO DRUGS LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24974 A III 5/1/2011 ESKAY PACKAGING ALUMINIUM COLLAPSIBLE TUBES SUITABLE FOR PACKAGING PHARMACEUTICAL
DOSAGES AS MANUFACTURED IN GOA, INDIA
24975 A II 5/18/2011 SHIJIAZHUANG LONZEAL
PHARMACEUTICALS CO LTD
EMTRICITABINE AS MANUFACTURED IN SHIJIAZHUANG, P.R. CHINA
24976 A II 5/25/2011 HETERO DRUGS LTD CLOPIDOGREL BISULFATE (FORM-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24977 A II 5/18/2011 LUNAN NEW TIME BIO TECH CO LTD MYCOPHENOLIC ACID AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA
24978 A II 5/20/2011 JINAN JINDA PHARMACEUTICAL CHEMISTRY
CO LTD
NITROFURANTOIN MONOHYDRATE AS MANUFACTURED IN SHANDONG, CHINA
24979 A III 5/23/2011 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEM 'S' DESIGN AS MANUFACTURED IN BANGALORE,
INDIA
24980 A II 5/21/2011 JINAN JINDA PHARMACEUTICAL CHEMISTRY
CO LTD
NITROFURANTOIN AS MANUFACTURED IN SHANDONG, CHINA
24981 A II 5/16/2011 CKD BIO CORP MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED
IN KYUNGGI-DO, SOUTH KOREA
24982 A II 5/25/2011 HETERO DRUGS LTD OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24983 P *** PENDING FILING REVIEW ***
24984 A IV 5/25/2011 FONA INTERNATIONAL INC 915.0527U N-C STRAWBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
24985 A IV 5/25/2011 FONA INTERNATIONAL INC 828.0030U CITRUS BLEND FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
24986 A IV 5/25/2011 FONA INTERNATIONAL INC 862.0061U N-C LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL
24987 A III 8/26/2011 RADPHARM SCIENTIFIC RADPHARM STERILE EVACUATED GLASS VIALS 10ML, 20ML, 30ML ( ESUB) AS
MAnUFACTURED IN BELCONNEN, AUSTRALIA
24988 I II 5/27/2011 SANDOZ GMBH FILGRASTIM (G-CSF) AS MANUFACTURED IN TYROL, AUSTRIA
24989 A II 5/26/2011 PIRAMAL ENTERPRISES LTD TOLCAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24990 A III 5/26/2011 HMC POLYMERS CO LTD PURELL RP271M AS MANUFACTURED IN RAYONG, THAILAND
Page 746
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24991 A III 5/26/2011 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINTER CLOSURE SYSTEM 'MRL' DESIGN AS MANUFACTURED IN
BANGALORE, INDIA
24992 A II 5/27/2011 CORDEN PHARMA COLORADO INC LINACLOTIDE AS MANUFACTURED IN BOULDER, COLORADO
24993 A III 5/27/2011 NUSSBAUM MATZINGEN AG ALUMINUM CANS AS MANUFACTURED IN MATZINGEN, SWITZERLAND AND
FRANKENBERG AND RIELASINGEN, GERMANY
24994 A III 5/27/2011 MYLAN TECHNOLOGIES INC MEDIRELEASE 2500 AS MANUFACTURED IN ST. ALBANS, VERMONT
24995 A II 5/25/2011 ST GOBAIN PERFORMANCE PLASTICS CORP C-FLEX ULTRA TPE TUBING AS MANUFACTURED IN CLEARWATER, FL
24996 A II 5/27/2011 SINOMEGA BIOTECH ENGINEERING CO LTD OMEGA-3 REFINED FISH OIL AS MANUFACTURED IN ZHEJIANG, CHINA
24997 A II 6/7/2011 AUROBINDO PHARMA LTD ARIPIPRAZOLE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
24998 A II 5/27/2011 HETERO DRUGS LTD PROGUANIL HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24999 A II 5/30/2011 FARMHISPANIA SA CISATRACURIUM BESYLATE AS MANUFACTURED IN MONTMELO, SPAIN
25000 I II 10/24/2011 INDOCO REMEDIES LTD QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25001 A II 5/31/2011 MACLEODS PHARMACEUTICALS LTD EMTRICITABINE AS MANUFACTURED IN VALSAD GUJARAT, INDIA
25002 A III 6/1/2011 FORMOSA CHEMICALS AND FIBRE CORP TAIRIPRO POLYPROPYLENE RESINS: K1023, T3002, F4007, K4515, K4535 & K4520 AS
MANUFACTURED IN TAIPEI, TAIWAN
25003 A II 11/4/2011 LUPIN LTD EFAVIRENZ USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25004 A IV 5/26/2011 UNGERER AND CO #41288 NATURAL MELON WONF FLAVOR AS MANUFACTURED IN BETHLEHEM, PA
25005 A II 5/19/2011 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
LEVETIRACETAM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25006 A II 5/31/2011 TORONTO RESEARCH CHEMICALS INC 2-AMINO-3,8-DIMETHYLIMIDAZOL[4,5-F]QUINOXALINE-2-14C AS MANUFACTURED IN
TORONTO, CANADA
25007 A II 6/1/2011 PHARMAZELL VIZAG PRIVATE LTD RISEDRONATE SODIUM HEMIPENTAHYDRATE USP AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25008 A II 6/1/2011 TOKO PHARMACEUTICAL INDUSTRIES CO
LTD
TAMIBAROTENE AS MANUFACTURED IN HOKKAIDO, JAPAN
25009 A II 6/3/2011 SEQUENT SCIENTIFIC LTD ZIDOVUDINE AS MANUFACTURED IN KARNATAKA, INDIA
25010 A II 5/20/2011 KOPRAN LTD ATENOLOL AS MANUFACTURED IN MAHARASHTRA STATE, INDIA
25011 A II 5/31/2011 PARABOLIC DRUGS LTD PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN HARYANA, INDIA
25012 A III 6/3/2011 SCHOTT NAIGAI KK INJECTION VIALS AND SCREW NECK VIALS IN CLEAR GLASS AND AMBER GLASS AS
MANUFACTURED IN OSAKA, JAPAN
25013 A II 6/7/2011 SHARON BIO MEDICINE LTD KETOCONAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25014 A II 9/5/2011 AMI ORGANICS PVT LTD 1- (2,3-DICHLORO PHENYL) PIPERAZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
25015 A II 9/5/2011 AMI ORGANICS PVT LTD 1-[2-(2-HYDROXY ETHOXY) ETHYL] PIPERAZINE (ESUB) AS MANUFACTURED IN GUJARAT,
INDIA
25016 A II 2/21/2012 NECTAR LIFESCIENCES LTD CEFEPIME HYDROCHLORIDE USP (STERILE) (ESUB) AS MANUFACTURED IN DISTRICT
MOHALI, (PUNJAB) INDIA
25017 A II 12/22/2011 NECTAR LIFESCIENCES LTD CEFEPIME HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE (ESUB) AS
MANUFACTURED IN DISTRICT MOHALI, (PUNJAB) INDIA
25018 A II 10/11/2011 NECTAR LIFESCIENCES LTD PYCA (ESUB) AS MANUFACTURED IN DISTRICT MOHALI, (PUNJAB) INDIA
25019 A IV 6/1/2011 LIPOID GMBH LIPOID LIPIDMIX HSPC/MPEG2000-DSPE/CHOLESTEROL (3/1/1) AS MANUFACTURED IN
LUDWIGSHAFEN, GERMANY
25020 I II 6/6/2011 SANOFI CHIMIE SEMULOPARIN SODIUM AS MANUFACTURED IN SINGAPORE
25021 A II 6/1/2011 POLYPEPTIDE LABORATORIES SWEDEN AB LINACLOTIDE DRUG SUBSTANCE AS MANUFACTURED IN LIMHAMN, SWEDEN
Page 747
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25022 A II 6/27/2011 GLENMARK GENERICS LTD MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA
25023 A II 6/8/2011 INTERQUIM SA OZENOXACIN AS MANUFACTURED IN BARCELONA, SPAIN
25024 A II 6/8/2011 TEVA PHARMACEUTICAL INDUSTRIES LTD SIMVASTATIN (ETHANOL PROCESS) AS MANUFACTURED IN DEBRECEN, HUNGARY
25025 A II 6/7/2011 POLYPEPTIDE LABORATORIES INC LINACLOTIDE DRUG SUBSTANCE AS MANUFACTURED IN TORRANCE, CA
25026 A III 5/25/2011 TEXOL SRL PERFORATED LAMINATE TOPSHEET 43 GSM AS MANUFACTURED IN ALLANO(PE), ITALY
25027 A III 6/1/2011 KURARAY TRADING CO LTD KG001, POLYPROPYLENE-KNITTED BACKING CLOTH FOR MEDICAL PATCHES AS
MANUFACTURED IN SAIJO-SHI, TOKYO, KAWAKITA-GUN, SABAE-SHI, JAPAN FOR
KURARAY TRADING CO., LTD.
25028 A II 6/9/2011 HETERO LABS LTD EFAVIRENZ(FORM-H1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25029 A II 6/9/2011 HETERO LABS LTD TELMISARTAN, USP (FORM A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25030 A II 2/4/2011 VITAL LABORATORIES PVT LTD RESERPINE USP AS MANUFACTURED IN GUJARAT, INDIA
25031 A II 6/23/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
ARMODAFINIL (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25032 A II 6/18/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25033 A III 5/3/2011 SABIC PETROCHEMICALS BV SABIC PP PCGR25 00900 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS
25034 A II 6/10/2011 DK PHARMA CHEM PVT LTD FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25035 A II 5/9/2011 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
AMPICILLIN TRIHYDRATE AS MANUFACTURED IN SHIJIAZHUANG, P.R. CHINA
25036 A II 6/9/2011 MACLEODS PHARMACEUTICALS LTD DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
25037 A III 6/8/2011 SOLVIN SA SOLVIN 372HA AS MANUFACTURED IN TAVAUX, FRANCE AND RHEINBERG, GERMANY
25038 A IV 4/30/2011 BALAJI AMINES LTD UNIT III POVIDONE USP-31 AS MANUFACTURED IN MAHARASHTRA STATE, INDIA
25039 A II 7/1/2011 EMCURE PHARMACEUTICALS LTD SEVELAMER CARBONATE (PROCESS II) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
25040 A II 7/1/2011 EMCURE PHARMACEUTICALS LTD MELPHALAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25041 A III 6/2/2011 INEOS SERVICES BELGIUM NV ELTEX MED HD5226EA-M AS MANUFACTURED IN LAVERA, FRANCE FOR INEOS SERVICES
BELGIUM NV
25042 A III 6/7/2011 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9696 TAN TRICOT FABRIC TAPE AS MANUFACTURED IN BROOKINGS, SD FOR
3M DRUG DELIVERY SYSTEMS
25043 A II 6/13/2011 SANDOZ PRIVATE LTD LANSOPROZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA
25044 A II 6/13/2011 CRYSTAL PHARMA SAU OLOPATADINE HYDROCHLORIDE, USP (PROCESS II) AS MANUFACTURED IN BOECILLO
(VALLADOLID), SPAIN
25045 A III 6/13/2011 MITSUI ELASTOMERS SINGAPORE PTE LTD TAFMER MY-1, MY-2, XM7070, XM7080 AND NOTIO PN-9060 AS MANUFACTURED IN
JURONG ISLAND, SINGAPORE AND CHIBA, JAPAN FOR MITSUI ELASTOMERS SINGAPORE
PTE LTD
25046 A IV 6/9/2011 NIPPON FINE CHEMICAL CO LTD PRESOME ESI AS MANUFACTURED IN TAKASAGO-CITY, JAPAN
25047 A III 6/15/2011 TOPPAN PRINTING CO LTD LOW ADSORPTION LAMINATED PACKAGING MATERIAL AS MANUFACTURED IN GUNMA,
JAPAN
25048 A II 6/14/2011 MACLEODS PHARMACEUTICALS LTD ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN CITY: VALSAD GUJARAT, INDIA
25049 A II 6/9/2011 PCAS ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN LIMAY, FRANCE
25050 A II 6/2/2011 PORTON FINE CHEMICALS LTD ROSUVASTATIN CALCIUM AS MANUFACTURED IN CHONGQING, P.R. CHINA
25051 A II 7/5/2011 UNICHEM LABORATORIES LTD BRIMONIDINE TARTRATE (ESUB) AS MANUFACTURED IN ROHA, DIST. RAIGAD, INDIA
25052 A II 6/16/2011 AMINO CHEMICALS LTD FESOTERODINE FUMARATE AS MANUFACTURED IN MARSA, MALTA
Page 748
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25053 A IV 6/8/2011 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9714 POLYETHYLENE FILM AS MANUFACTURED IN BROOKINGS, SD FOR 3M
DRUG DELIVERY SYSTEMS
25054 A II 6/14/2011 ACEBRIGHT INDA PHARMA PRIVATE LTD CAPECITABINE USP[DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN
KARNATAKA, INDIA
25055 A II 7/20/2011 CADILA HEALTHCARE LTD PROPAFENONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25056 A II 6/17/2011 HUBEI GEDIAN HUMANWELL
PHARMACEUTICAL CO LTD
FINASTERIDE AS MANUFACTURED IN HUBEI, CHINA
25057 A III 5/12/2011 AMCOR FLEXIBLES AS OPP40/ALU9/OPP40 AS MANUFACTURED IN DRAMMEN, NORWAY
25058 A II 6/15/2011 RA CHEM PHARMA LTD PHTHALAZINONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25059 A III 6/17/2011 MINNESOTA RUBBER AND PLASTICS POLYISOPRENE RUBBER FOR SEALING AND OTHER MEDICAL-RELATED APPLICATIONS
IN MEDICAL DEVICES AS MANUFACTURED IN GUANGDONG, P. R. CHINA FOR MINNESOTA
RUBBER & PLASTICS
25060 A II 6/14/2011 CHEMSPEC CHEMICALS PVT LTD TRICLOCARBAN AS MANUFACTURED IN MAHARASHTRA, INDIA
25061 I II 6/20/2011 PHARMACEUTICAL WORKS POLPHARMA SA MONTELUKAST SODIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
25062 A II 6/16/2011 RAKS PHARMA PVT LTD DOXYCYCLINE, USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25063 A III 6/14/2011 RAVIRAJ FOILS LTD CHILD RESISTANT BLISTER PACK LIDDING MATERIAL (PLAIN / PRINTED)' AS
MANUFACTURED IN GUJARAT, INDIA
25064 A II 6/21/2011 MSN PHARMACHEM PVT LTD PREGABALIN[ROUTE CODE: "PU"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25065 A II 6/16/2011 RAKS PHARMA PVT LTD CITALOPRAM HYDROBROMIDE, USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25066 A III 6/14/2011 LORMAC INDUSTRIAL DISTRIBUTORS LTD LORMAC TYPE 40 POLYETHYLENE AS MANUFACTURED IN BRIGHOUSE, UNITED
KINGDOM AND CORK, IRELAND FOR LORMAC INDUSTRIAL DISTRIBUTORS LTD.
25067 A II 6/18/2011 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
METHYLPREDNISOLONE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
ZHEJIANG, CHINA
25068 A II 6/22/2011 MOEHS IBERICA SL ARTICAINE HCL AS MANUFACTURED IN BELGIUM AND RUBI (BCN), SPAIN FOR MOEHS
IBERICA, S. L.
25069 A II 6/22/2011 APOTEX PHARMACHEM INDIA PVT LTD LETROZOLE USP AS MANUFACTURED IN KARNATAKA STATE, INDIA
25070 A II 6/20/2011 R.N. LABORATORIES PVT LTD. CHLORHEXIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
25071 A III 6/10/2011 RKW SE HYFOL PE SOFT TEXTILE - 45701 AS MANUFACTURED IN WASSERBURG, GERMANY
25072 A III 1/22/2014 SCHOTT SCHWEIZ AG PRIMARY PACKAGING MATERIAL SYRINGES AS MANUFACTURED IN ST. GALLEN,
SWITZERLAND
25073 A II 6/24/2011 APOTEX PHARMACHEM INDIA PVT LTD PALIPERIDONE AS MANUFACTURED IN KARNATAKA STATE, INDIA
25074 A II 6/24/2011 APOTEX PHARMACHEM INDIA PVT LTD ALPRAZOLAM USP AS MANUFACTURED IN KARNATAKA STATE, INDIA
25075 A II 6/24/2011 COVALENT LABORATORIES PRIVATE LTD CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
25076 A II 6/27/2011 MYLAN LABORATORIES LTD ELETRIPTAN HYDROBROMIDE (PROCESS 2) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
25077 A III 6/18/2011 GREEN PACK FOILS PRIVATE LTD CHILD RESISTANT BLISTER PACK LIDDING FOIL (PLAIN / PRINTED)'. AS MANUFACTURED
IN GUJARAT, INDIA
25078 A II 8/26/2011 SUN PHARMACEUTICAL INDUSTRIES LTD ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25079 A III 6/10/2011 UNITIKA LTD EMBLET PET,S AS MANUFACTURED IN KYOTO, JAPAN FOR UNITIKA LTD.
25080 A II 4/20/2011 F.I.S.-FABBRICA ITALIANA SINTETICI S.P.A. ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN VICENZA, ITALY
25081 A II 7/20/2009 AARTI INDUSTRIES LTD IFOSFAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
25082 I II 6/17/2011 MATRIX PHARMA GROUP XIAMEN LTD ZIDOVUDINE USP AS MANUFACTURED IN XIAMEN, P.R. CHINA
25083 A II 6/18/2011 MYLAN LABORATORIES LTD S-PREGABALIN (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
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25084 I II 6/28/2011 RANBAXY LABORATORIES LTD QUETIAPINE FUMARATE (NON-STERILE BULK) AS MANUFACTURED IN HARYANA, INDIA
FOR RANBAXY LABORATORIES LIMITED
25085 A II 6/12/2011 ZHEJIANG HUAFANG PHARMACEUTICAL CO
LTD
CEFCAPENE PIVOXIL HYDROCHLORIDE HYDRATE AS MANUFACTURED IN ZHEJIANG,
CHINA
25086 A II 6/12/2011 ZHEJIANG HUAFANG PHARMACEUTICAL CO
LTD
CEFDITOREN PIVOXIL AS MANUFACTURED IN ZHEJIANG, CHINA
25087 A II 6/28/2011 JOHNSON MATTHEY PHARMA SERVICES 3011.H AS MANUFACTURED IN DEVENS, MA
25088 A II 6/29/2011 HETERO DRUGS LTD CITALOPRAM HYDROBROMIDE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
25089 A II 6/29/2011 REGIS TECHNOLOGIES INC DAPSONE, USP AS MANUFACTURED IN MORTON GROVE, IL
25090 A II 7/27/2011 EXCELLA GMBH BUPIVACAINE (S) HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY
25091 A IV 6/20/2011 SUMITOMO SEIKA CHEMICALS CO LTD PEO-1NF, A LOW MOLECULAR WEIGHT POLYETHYLENE OXIDE AS MANUFACTURED IN
HYOGO, JAPAN
25092 A II 7/26/2011 USV LIMITED EPTIFIBATIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25093 A II 6/30/2011 RELIABLE BIOPHARMACEUTICAL CORP FONDAPARINUX SODIUM AS MANUFACTURED IN ST. LOUIS, MO
25094 A II 7/14/2011 NANTONG JINGHUA PHARMACEUTICAL CO
LTD
FLUCYTOSINE (ESUB) AS MANUFACTURED IN NANTONG JIANGSU, CHINA
25095 I II 6/24/2011 JOYANG LABORATORIES BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, CHINA
25096 A II 7/1/2011 MUSTAFA NEVZAT ILAC SANAYII AS NON-STERILE SULBACTAM SODIUM AS MANUFACTURED IN CAYIROVA-KOCAELI, TURKEY
25097 A II 6/29/2011 MOEHS IBERICA SL SERTRALINE HCL FORM 1 (SCHIFF BASE) AS MANUFACTURED IN RUBI (BARCELONA),
SPAIN FOR MOEHS IBERICA S.L.
25098 A II 6/30/2011 BACHEM SA TOPOTECAN HYDROCLORIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND
25099 A II 6/30/2011 ALEMBIC PHARMACEUTICALS LTD BOSENTAN AS MANUFACTURED IN GUJARAT, INDIA
25100 A II 7/4/2011 APOTEX PHARMACHEM INDIA PVT LTD VORICONAZOLE AS MANUFACTURED IN BANGALORE, INDIA
25101 A III 7/1/2011 AGI GLASPAC BHONGIR UNIT GLASS BOTTLES USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25102 A II 9/21/2011 SHILPA MEDICARE LTD PEMETREXED DISODIUM (HEMIPENTA HYDRATE) (ESUB) AS MANUFACTURED IN
KARNATAKA, INDIA
25103 I II 7/20/2011 FRESENIUS KABI ONCOLOGY LTD DOCETAXEL(ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA
25104 A II 7/4/2011 MACLEODS PHARMACEUTICALS LTD MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT, INDIA
25105 A III 6/27/2011 PIONEER EXTRUDERS PVT LTD COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN DAMAN, INDIA
25106 A II 7/6/2011 SANOFI AVENTIS CHIMIE TRIMIPRAMINE MALEATE AS MANUFACTURED IN CEDEX, FRANCE
25107 A II 6/30/2011 YUNG ZIP CHEMICAL IND CO LTD DICLOFENAC ACID AS MANUFACTURED IN TAICHUNG, TAIWAN
25108 A II 5/31/2011 OG CORP POLYESTER KNITTING CLOTH FOR BACKING LINER AS MANUFACTURED IN FUKUI CITY,
JAPAN FOR OG CORPORATION
25109 A III 7/8/2011 POLYCINE GMBH APP114 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY
25110 A III 7/8/2011 POLYCINE GMBH APP218 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY
25111 A II 6/30/2011 MYLAN LABORATORIES LTD DEXLANSOPRAZOLE AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25112 A IV 7/8/2011 GANGWAL CHEMICALS PVT. LTD. SUCRALOSE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25113 A III 7/6/2011 VITEX PACKAGING GROUP VITEX POUCH 40493 AS MANUFACTURED IN SUFFOLK, VA
25114 A III 5/16/2011 ST GOBAIN PERFORMANCE PLASTICS CORP D9899000-12 AS MANUFACTURED IN POESTENKILL, NEW YORK
25115 A II 7/12/2011 HETERO LABS LTD MARAVIROC (FORM-B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25116 A II 7/12/2011 HETERO LABS LTD IMATINIB MESYLATE AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
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25117 A II 7/7/2011 PHARMACEUTICAL WORKS POLPHARMA SA ROSUVASTATIN CALCIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
25118 A II 7/12/2011 HETERO LABS LTD SAQUINAVIR MESYLATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25119 A II 6/20/2011 VITAL LABORATORIES PVT LTD METHYLCOBALAMIN (MECOBALAMIN) AS MANUFACTURED IN GUJARAT, INDIA
25120 A II 6/30/2011 SECOND PHARMA CO LTD LEVETIRACETAM AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. CHINA
25121 A II 7/13/2011 HETERO LABS LTD MARAVIROC AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25122 A II 7/13/2011 HAINAN POLY PHARMACEUTICAL CO LTD GANCICLOVIR SODIUM AS MANUFACTURED IN ZHEJIANG, CHINA
25123 A II 7/11/2011 PROCOS SPA DIMIRACETAM AS MANUFACTURED IN CAMERI (NO) - ITALY
25124 A III 7/12/2011 MITSUI MINING AND SMELTING CO LTD OMNIBATCH AS MANUFACTURED IN CHIBA, JAPAN FOR POWDERTECH CO., LTD.
25125 A II 7/11/2011 LIFE TECHNOLOGIES CORP HUMAN GROWTH FACTORS AS MANUFACTURED IN FREDERICK, MD
25126 A III 7/14/2011 THE JENARD CO DIV FEY INDUSTRIES INC DISCREET SLEEVE PACKAGING FOR ORAL CONTRACEPTIVES AS MANUFACTURED IN
EDGERTON, MN FOR THE JENARD COMPANY, A DIVISION OF FEY INDUSTRIES, INC
25127 A II 5/11/2011 KOTHARI PHYTOCHEMICALS
INTERNATIONAL
CHLORPROPAMIDE AS MANUFACTURED IN TAMILNADU, INDIA
25128 A II 6/30/2011 HEMMO PHARMACEUTICALS PVT LTD LEUPRORELIN PH.EUR. AS MANUFACTURED IN DISTRICT THANE, INDIA
25129 A II 7/15/2011 SHANDONG LUKANG PHARMACEUTICAL CO
LTD
SPECTINOMYCIN HYDROCHLORIDE HCI USP, NON-STERILE, BULK DRUG SUBSTANCE AS
MANUFACTURED IN SHANDONG, P. R. CHINA
25130 A III 6/13/2011 CHARTER NEX FILMS INC NEX S9149 SINGLE-LAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN
TURNERS FALLS, MA AND MILTON, WI
25131 A II 7/5/2011 JOST CHEMICAL CO CALCIUM SUCCINATE, MONOHYDRATE AS MANUFACTURED IN ST. LOUIS, MO
25132 A II 7/5/2011 JOST CHEMICAL CO SODIUM PHOSPHATE DIBASIC, ANHYDROUS AS MANUFACTURED IN ST. LOUIS, MO
25133 A II 7/5/2011 JOST CHEMICAL CO MAGNESIUM SULFATE DRIED AS MANUFACTURED IN ST. LOUIS, MO
25134 A II 9/9/2011 WATSON PHARMA PRIVATE LTD AMBRISENTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25135 A II 7/5/2011 JOST CHEMICAL CO SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE AS MANUFACTURED IN ST. LOUIS,
MO
25136 A III 7/12/2011 ARTUBE IRIDIUM INDUSTRIES INC MONO LAYER AND COEX LAYER PLASTIC TUBES AS MANUFACTURED IN EAST
STROUDSBURG, PA
25137 A III 7/11/2011 BASELL POLYOLEFINE ITALIA SRL PURELL ACP 5231 D AS MANUFACTURED IN FRANKFURT AM MAIN AND
MUNCHSMUNSTER, GERMANY FOR BASELL POLYOLEFINE ITALIA S. R. L.
25138 A II 9/9/2011 CHEMWERTH INC CLOCORTOLONE PIVALATE NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN
TIANJIN, PR CHINA
25139 A IV 7/15/2011 JIANGSU ZODIAC MARINE BIOTECHNOLOGY
CO LTD
EMPTY HARD CARRAGEENAN CAPSULES AS MANUFACTURED IN JIANGSU, CHINA
25140 A III 6/6/2011 STYROLUTION EUROPE GMBH TERLUX 2822 HD AS MANUFACTURED IN LUDWIGSHAFEN AND SCHWARZHEIDE,
GERMANY
25141 A II 10/19/2011 LUPIN LTD L-5-METHYL TETRAHYDROFOLATE CALCIUM (AMORPHOUS)(ESUB) AS MANUFACTURED
IN MAHARASHTRA, INDIA
25142 A II 8/20/2011 ARCH PHARMALABS LTD DOCETAXEL ANHYDROUS USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25143 A II 9/5/2011 ARCH PHARMALABS LTD DOCETAXEL TRIHYDRATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25144 A II 8/6/2011 CADILA HEALTHCARE LTD ZYFINE ERLOTINIB HYDROCHLORIDE (FORM-A) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25145 A II 8/4/2011 JUBILANT HOLLISTERSTIER LLC STERILE EVACUATED VIALS (ESUB) AS MANUFACTURED IN SPOKANE, WA
25146 A IV 7/19/2011 UNGERER AND CO ARTIFICIAL PINA COLADA FLAVOR FT-11512 AS MANUFACTURED IN BETHLEHEM, PA
25147 A II 7/20/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD SIROLIMUS AS MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA
Page 751
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25148 A II 3/4/2011 ALP PHARM BEIJING CO LTD DOXERCALCIFEROL AS MANUFACTURED IN LIAONING PROVINCE, CHINA FOR ALP
PHARM BEIJING CO., LTD.
25149 A II 7/25/2011 MEDICHEM SA CHLORHEXIDINE GLUCONATE SOLUTION (DGLP) AS MANUFACTURED IN CELRA
(GIRONA), SPAIN
25150 A III 7/18/2011 PIRAMIDA DOO PHARMACEUTICAL GLASS PACKAGING - AMPOULES AND VIALS AS MANUFACTURED IN
SESVETE, CROATIA
25151 A II 7/21/2011 ZHEJIANG APELOA KANGYU
PHARMACEUTICAL CO LTD
AMANTADINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJINAG PROVINCE, P.R. CHINA
25152 A II 7/29/2011 ALKEM LABORATORIES LTD LANSOPRAZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25153 A III 7/19/2011 AMPACET CORP 173834 TRANS GREEN SMC PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,
LA, CARTERSVILLE, GA AND HEATH, OH
25154 A II 5/20/2011 AICELLOMILIM CHEMICAL CO LTD ADF-03 (CLEAN BAG) AS MANUFACTURED IN GYEONGGI-DO, KOREA
25155 A II 9/29/2011 UNICHEM LABORATORIES LTD TOLTERODINE TARTARATE (ESUB) AS MANUFACTURED IN DIST. RAIGAD, INDIA
25156 I II 11/14/2011 RELIANCE LIFE SCIENCES PVT LTD ROCURONIUM BROMIDE USP (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
25157 A V 5/18/2011 ROTEM INDUSTRIES LTD CASSETTE FOR THE PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE
TRACERLAB MX FDG SYNTHESIS UNIT, TYPE B AS MANUFACTURED IN MISHOR YAMIN ,
ISRAEL
25158 A II 7/25/2011 AMERICA STEM CELL INC ASC-1401 AS MANUFACTURED IN ALACHUA, FLORIDA FOR AMERICA STEM CELL, INC
25159 A III 7/26/2011 JSR CORP JSR DYNARON SERIES (HYDROGENATED STYRENE BUTADIENE COPOLYMER) AS
MANUFACTURED IN MIE, JAPAN
25160 A III 9/16/2011 HOSPIRA INC ANSYR SYRINGE DRUG CONTAINER (ESUB) AS MANUFACTURED IN ROCKY MOUNT, NC
25161 A II 7/25/2011 PCAS TAZAROTENE AS MANUFACTURED IN TURKU, FINLAND FOR PCAS
25162 A III 7/27/2011 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT MASTERBATCH N06534 BROWN AS MANUFACTURED
IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
25163 A III 7/25/2011 ELIX POLYMERS SL ELIX ABS M210TF, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN
25164 A IV 7/26/2011 UNGERER AND CO NATURAL AND ARTIFICIAL CHERRY FLVP FT-9496 AS MANUFACTURED IN BETHLEHEM,
PA
25165 A II 4/14/2011 HYBIO PHARMACEUTICAL CO LTD BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
GUANGDONG, P. R. CHINA
25166 A II 3/30/2011 AUCTUS PHARMA LTD PANTOPRAZOLE SODIUM SESQUIHYDRATE USP AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25167 A II 7/19/2011 LI COR BIOSCIENCES INC IRDYE 800CW NHS ESTER(DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN
MORTON GROVE, IL FOR LI-COR BIOSCIENCES, INC.
25168 A II 7/1/2011 KOTHARI PHYTOCHEMICALS
INTERNATIONAL
TOLBUTAMIDE USP AS MANUFACTURED IN TAMILNADU, INDIA
25169 A II 7/15/2011 TAI HENG INDUSTRY CO LTD BOSENTAN MONOHYDRATE AS MANUFACTURED IN SHANGHAI, P.R. CHINA
25170 P *** PENDING FILING REVIEW ***
25171 A III 7/25/2011 CV HOLDINGS LLC 5ML GLASS COATED PARENTERAL DRUG VIAL AS MANUFACTURED IN AUBURN,
ALABAMA
25172 A II 9/9/2011 EMCURE PHARMACEUTICALS LTD IBANDRONATE SODIUM MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
25173 A II 7/20/2011 ZHEJIANG GOLDEN-SHELL
PHARMACEUTICAL CO LTD
CHITOSAN AS MANUFACTURED IN ZHEJIANG, CHINA
25174 A II 8/2/2011 PHARMACEUTICAL WORKS POLPHARMA SA VARDENAFIL HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
Page 752
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25175 A II 7/29/2011 QILU PHARMACEUTICAL CO LTD OLANZAPINE AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF
CHINA
25176 A III 8/2/2011 JIANGSU BEST NEW MEDICAL MATERIAL CO
LTD
BROMOBUTYL RUBBER STOPPERS FOR INFUSION BOTTLES AS MANUFACTURED IN
JIANGSU, CHINA
25177 A III 8/2/2011 JIANGSU BEST NEW MEDICAL MATERIAL CO
LTD
BROMOBUTYL RUBBER STOPPERS FOR INJECTION VIALS AS MANUFACTURED IN
JIANGSU, CHINA
25178 A III 8/2/2011 JIANGSU BEST NEW MEDICAL MATERIAL CO
LTD
FREEZE DRYING BROMOBUTYL RUBBER STOPPERS FOR INJECTION VIALS AS
MANUFACTURED IN JIANGSU, CHINA
25179 A III 2/23/2011 TEKNOR COLOR CO 47,264CP MOM BLUE 25/1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE,
TX
25180 P *** PENDING FILING REVIEW ***
25181 A II 7/20/2011 ZHEJIANG GOLDEN-SHELL
PHARMACEUTICAL CO LTD
N-ACETYL-D-GLUCOSAMINE AS MANUFACTURED IN ZHEJIANG, CHINA
25182 A II 8/3/2011 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
CLOZAPINE AS MANUFACTURED IN SHOUGUANG CITY, P.R. OF CHINA
25183 A V 7/29/2011 ECKERT AND ZIEGLER EUROTOPE GMBH MODULAR-LAB RADIOPHARMACEUTICAL SYNTHESIS SYSTEMS AS MANUFACTURED IN
BERLIN, GERMANY
25184 A III 7/29/2011 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK 9758 POLYESTER FILM AS MANUFACTURED IN DECATUR, ALABAMA,
GREENVILLE, SC AND HUTCHINSON, MN FOR 3M DRUG DELIVERY SYSTEMS
25185 A II 8/11/2011 DR REDDYS LABORATORIES LTD BROMFENAC SODIUM SESQUIHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25186 A II 8/22/2011 DR REDDYS LABORATORIES LTD O-DESMETHYL VENLAFAXINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25187 A II 10/24/2011 GILEAD SCIENCES INC ELVITEGRAVIR (ESUB) AS MANUFACTURED IN ALBERTA, CANADA, VICENZA, ITALY AND
KYUNGGI-DO, SOUTH KOREA FOR GILEAD SCIENCES, INC
25188 A II 10/25/2011 GILEAD SCIENCES INC COBICISTAT ON SILICON DIOXIDE (ESUB) AS MANUFACTURED IN ALBERTA, CANADA AND
KYUNGGI-DO, SOUTH KOREA FOR GILEAD SCIENCES, INC
25189 A II 12/21/2011 GLAXOSMITHKLINE LLC ALBUTEROL (ESUB) AS MANUFACTURED IN ANGUS, UNITED KINGDOM AND EVREUX,
FRANCE FOR GLAXO GROUP LIMITED D/B/A GLAXOSMITHKLINE
25190 A II 8/4/2011 MYLAN LABORATORIES LTD EFAVIRENZ USP(PROCESS - II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
MYLAN LABORATORIES LIMITED
25191 I II 8/5/2011 SPI PHARMA INC BULK ACTIMASK TASTE MASKED ACETAMINOPHEN AS MANUFACTURED IN GRAND
HAVEN, MICHIGAN
25192 A II 8/3/2011 OLON SPA TRETINOIN TYPE 2 AS MANUFACTURED IN GARBAGNATE MILANESE (MI) - ITALY
25193 A II 6/1/2011 OLON SPA DIENOGEST AS MANUFACTURED IN RODANO (MI), ITALY
25194 A II 8/9/2011 SHARON BIO MEDICINE LTD MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
25195 A II 8/1/2011 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
TRIMETHOPRIM AS MANUFACTURED IN SHOUGUANG CITY, CHINA
25196 A V 6/3/2011 COLORCON INC SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCT POLYVINYL ACETATE
PHTHALATE (PVAP)" AS MANUFACTURED IN WEST POINT, PA
25197 A II 8/10/2011 SYMBIOTEC PHARMALAB LTD BETAMETHASONE, USP (MICRONIZED) AS MANUFACTURED IN DIST. DHAR, (M.P.), INDIA
25198 A II 8/10/2011 GMT FINE CHEMICALS SA LEVOLEUCOVORIN CALCIUM AS MANUFACTURED IN COUVET, SWITZERLAND
25199 A III 8/5/2011 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9759 DOUBLE-COATED MEDICAL TAPE AS MANUFACTURED IN BROOKINGS,
SD FOR 3M DRUG DELIVERY SYSTEMS
25200 A II 8/5/2011 ZHEJIANG AUSUN PHARMACEUTICAL CO
LTD
ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG,
CHINA
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25201 A II 8/5/2011 LONZA AG FLUVOXAMINE MALEATE (SV-006) AS MANUFACTURED IN VISP, SWITZERLAND
25202 I II 7/29/2011 QILU PHARMACEUTICAL CO LTD RISPERIDONE PROCESS II (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE, P. R. OF CHINA
25203 I II 7/30/2011 QILU PHARMACEUTICAL CO LTD VINORELBINE TARTRATE (PROCESS I) (NON STERILE, API) AS MANUFACTURED IN
SHANDONG PROVINCE, P. R. OF CHINA
25204 A II 8/1/2011 FIS FABBRICA ITALIANA SINTETICI SPA MIDAZOLAM HCI AS MANUFACTURED IN VICENZA, ITALY
25205 A II 7/26/2011 FIS FABBRICA ITALIANA SINTETICI SPA IMATINIB MESYLATE (BETA FORM) AS MANUFACTURED IN VICENZA, ITALY
25206 A II 7/27/2011 FIS FABBRICA ITALIANA SINTETICI SPA IMATINIB MESYLATE (ALPHA FORM) AS MANUFACTURED IN VICENZA, ITALY
25207 A II 7/11/2011 HEBEI HUARONG PHARMACEUTICAL CO LTD ACARBOSE AS MANUFACTURED IN HEBEI, CHINA
25208 A III 8/9/2011 ROY AND LECLAIR EMBALLAGE INC EYE APPLICATOR BRUSH AS MANUFACTURED IN OMAHA, NE FOR ROY AND LECLAIR
EMBALLAGE INC.
25209 A III 8/15/2011 MITSUBISHI GAS CHEMICAL CO INC NYLON MXD-6 GRADES FOR USE IN PHARMACEUTICAL PACKAGING APPLICATIONS AS
MANUFACTURED IN COLONIAL HEIGHTS, VIRGINIA AND NIIGATA, JAPAN FOR MITSUBISHI
GAS CHEMICAL CO., INC
25210 A IV 8/12/2011 NEOPHARM CO LTD MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ ARACHAMIDE MEA (CODE NAME: PC-9S) AS
MANUFACTURED IN DAEJEON, KOREA
25211 A II 8/5/2011 ZHEJIANG APELOA KANGYU BIO
PHARMACEUTICAL CO LTD
TYLOSIN TARTRATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
25212 A II 8/16/2011 HOSPIRA BOULDER INC ISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN
BOULDER, CO
25213 A II 8/10/2011 ANHUI BBCA LIKANG PHARMACEUTICAL CO
LTD
ACETAMINOPHEN AS MANUFACTURED IN BENGBU CITY, CHINA
25214 A II 8/1/2011 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
SULFAMETHOXAZOLE AS MANUFACTURED IN SHOUGUANG CITY, CHINA
25215 A III 8/18/2011 SABIC PETROCHEMICALS BV SABIC HDPE PCG300054 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS
25216 A II 8/11/2011 ULKAR KIMYA SANAYII VE TICARET AS CANDESARTAN CILEXETIL AS MANUFACTURED IN TEKIRDAG, TURKEY
25217 A II 8/26/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
CLOPIDOGREL BISULFATE(ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25218 A II 8/18/2011 JOHNSON MATTHEY PHARMACEUTICAL
MATERIALS
JOHNSON MATTHEY 4147.F AS MANUFACTURED IN DEVENS, MA FOR JOHNSON
MATTHEY PHARMACEUTICAL MATERIALS
25219 A II 8/16/2011 PARABOLIC DRUGS LTD CANDESARTAN CILEXETIL AS MANUFACTURED HARYANA, INDIA
25220 A IV 8/19/2011 DAVID MICHAEL AND CO INC NATURAL AND ARTIFICIAL LEMON FLAVOR #11980 AS MANUFACTURED IN PHILADELPHIA,
PA
25221 I II 8/22/2011 MATRIX PHARMA GROUP XIAMEN LTD NEVIRAPINE ANHYDROUS USP AS MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA
25222 A II 11/9/2011 SHILPA MEDICARE LTD BENDAMUSTINE HCL AS MANUFACTURED IN KARNATAKA, INDIA
25223 A II 12/20/2011 EPAX NORWAY AS EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER) (ESUB) AS
MANUFACTURED IN AALESUND, NORWAY
25224 A II 9/16/2011 AMOLI ORGANICS PVT LTD DICLOFENAC EPOLAMINE/DICLOFENAC APOLAMINE (ESUB) AS MANUFACTURED IN
GUJARAT STATE, INDIA
25225 A II 8/16/2011 APOTEX PHARMACHEM INDIA PVT LTD ALMOTRIPTAN MALATE AS MANUFACTURED IN KARNATAKA, INDIA
25226 A II 8/18/2011 DECCAN NUTRACEUTICALS PVT LTD 10-DEACETYL BACCATIN III (10-DAB III) AS MANUFACTURED IN MAHARASHTRA, INDIA
25227 A II 8/18/2011 PERRIGO API LTD OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL
25228 A II 8/23/2011 FARMABIOS S P A DIFLUPREDNATE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY
Page 754
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25229 A II 3/7/2011 ALP PHARM BEIJING CO LTD RIZATRIPTAN BENZOATE AS MANUFACTURED IN CHONGQING, CHINA FOR ALP PHARM
BEIJING CO., LTD
25230 A V 6/14/2011 BIOSCAN INC F18-PLUS SYNTHESIZER FOR PRODUCTION OF PET TRACERS AS MANUFACTURED IN
YORK, PA FOR BIOSCAN, INC.
25231 A II 11/2/2011 AMOLI ORGANICS PVT LTD SILDENAFIL CITRATE FORM-II (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
25232 A V 8/23/2011 ION BEAM APPLICATIONS SA RADIO-HARMACEUTICAL SYNTHESIS MODULE SYNTHERA V2 AS MANUFACTURED
LOUVAIN-LA NEUVE, BELGIUM
25233 A III 8/17/2011 TEKNOR APEX CO MEDALIST MD-555 NATURAL AS MANUFACTURED IN HENDERSON, KY AND SAINT
ALBANS, VT FOR TEKNOR APEX COMPANY
25234 A II 8/17/2011 ROVI CONTRACT MANUFACTURING SL STERILE WATER FOR INJECTION, USP, 5.0 ML AS MANUFACTURED IN MADRID, SPAIN
25235 A II 8/31/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
DEXLANSOPRAZOLE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25236 A II 9/16/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25237 A III 8/23/2011 PRAVESHA INDUSTRIES PRIVATE LTD MASTER BATCH/COLORANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25238 A II 8/25/2011 HETERO DRUGS LTD SERTRALINE HYDROCHLORDE, USP (FORM II), PROCESS II AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25239 A II 11/7/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
DORIPENEM (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25240 A II 9/19/2011 OTSUKA AMERICA PHARMACEUTICAL INC STERILE WATER FOR INJECTION USP, 2 ML VIAL (ESUB) AS MANUFACTURED IN HAMELN,
GERMANY FOR OTSUKA AMERICA PHARMACEUTICAL, INC.
25241 A III 8/16/2011 CHEMIPACK INDIA PRIVATE LTD 'HDPE BOTTLE' AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25242 A II 8/29/2011 HANGZHOU JIUYUAN GENE ENGINEERING
CO LTD
ENOXAPARIN SODIUM AS MANUFACTURED IN HANGZHOU, CHINA
25243 A V 10/28/2011 WYETH LEDERLE S.R.L CATANIA NON-PENICILLIN VIALS DEPARTMENT (01) ASEPTIC FACILITY (ESUB) AS
LOCATED IN CATANIA, ITALY
25244 A V 8/29/2011 ION BEAM APPLICATIONS SA RADIO-PHARMACEUTICAL SYNTHESIS MODULE << SYNTHERA V1 >> AS
MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM
25245 A II 8/18/2011 INDOCO REMEDIES LTD BROMFENAC SODIUM (ESUB) AS MANUFACTURED IN MUMBAI INDIA
25246 A II 6/20/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MANGANESE GLUCONATE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
25247 A II 8/26/2011 BIOCON LTD ATORVASTATIN CALCIUM CRYSTALLINE AS MANUFACTURED IN BANGALORE, INDIA
25248 A II 9/1/2011 AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC) AS MANUFACTURED IN
ALABASTER, ALABAMA
25249 A II 9/1/2011 NATIONAL CANCER INSTITUTE DIV CANCER
TREATMENT AND DIAGNOSIS
RECOMBINANT HUMAN INTERLEUKIN-15 (RHIL-15) AS MANUFACTURED IN FREDERICK,
MD FOR NATIONAL CANCER INSTITUTE (NCI), DIVISIO OF CANCER TREATMENT AND
DIAGNOSIS (DCTD)
25250 A V 8/29/2011 ION BEAM APPLICATIONS SA SYNTHERA?INTEGRATED FLUIDIC PROCESSOR AS MANUFACTURED IN LOUVAIN-LA-
NEUVE, BELGIUM
25251 A II 9/6/2011 LABORCHEMIE APOLDA GMBH DIENOGEST AS MANUFACTURED IN THURINGIA, GERMANY
25252 A II 8/30/2011 GUFIC BIOSCIENCES LTD PRILOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA
25253 A III 9/1/2011 VISTAPAC(HK)INDUSTRIAL LTD DESICCANT TYPE PACKAGING MATERIAL AS MANUFACTURED IN DONGGUAN CITY, P.R.
CHINA FOR VITAPAC (HK) INDUSTRIAL LTD.
25254 A II 8/23/2011 ZHEJIANG SUPOR PHARMACEUTICALS CO
LTD
BUPROPION HYDROBROMIDE AS MANUFACTURED IN ZHEJIANG, P. R. CHINA
25255 A II 9/1/2011 NOF CORP DLINDMA (1,2-DILINOLEYLOXY-N,N-DIMETHYLPROPYLAMINE AS MANUFACTURED IN
HYOGO AND KANAGAWA, JAPAN
Page 755
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25256 A II 9/1/2011 VIFOR INTERNATIONAL INC CARBOXYMETHYLATED DEXTRAN (CM DEXTRAN) AS MANUFACTURED IN GALLEN,
SWITZERLAND
25257 A II 5/3/2012 AMI ORGANICS PVT LTD 1- (2-METHOXYPHENYL) PIPERAZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
25258 A II 10/11/2011 IPCA LABORATORIES LTD PRIMAQUINE PHOSPHATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
25259 A II 10/11/2011 LUPIN LTD BRIMONIDINE TARTRATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
25260 A II 9/24/2011 ALKEM LABORATORIES LTD RILUZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25261 A II 9/6/2011 HETERO DRUGS LTD RALTEGRAVIR POTASSIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25262 A II 9/6/2011 HETERO LABS LTD EFAVIRENZ (PROCESS III) USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25263 A II 9/2/2011 EVERLIGHT CHEMICAL INDUSTRIAL CORP TRAVOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN
25264 A V 8/31/2011 ION BEAM APPLICATIONS SA RADIO-PHARMACEUTICAL PURIFICATION/SEPARATION MODULE SYNTHERA HPLC AS
MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM
25265 A II 9/7/2011 EUTICALS SPA AZACITIDINE AS MANUFACTURED IN VARESE, ITALY
25266 A II 9/7/2011 EUTICALS SPA CAPECITABINE AS MANUFACTURED IN LODI, ITALY
25267 A II 9/7/2011 EUTICALS SPA CYTARABINE AS MANUFACTURED IN VARESE, ITALY
25268 A II 4/27/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM SULFATE, ANHYDROUS AS MANUFACTURED IN TOKUSHIMA, JAPAN
25269 A II 5/10/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
25270 A II 5/23/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM OXIDE HEAVY POWDER AS MANUFACTURED IN TOKUSHIMA, JAPAN
25271 A II 5/23/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM OXIDE HEAVY FINE GRANULAR AS MANUFACTURED IN TOKUSHIMA,
JAPAN
25272 A II 2/28/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGALDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
25273 A II 10/6/2011 BAYER PHARMA AG NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RUBI
(BCN), SPAIN
25274 A II 10/6/2011 BAYER PHARMA AG NICLOSAMIDE 500MG TABLET (ESUB) AS MANUFACTURED IN TURKU, FINLAND
25275 A II 7/25/2011 SYMBIOTICA SPECIALITY INGREDIENTS SDN
BHD
EXEMESTANE AS MANUFACTURED IN KEDAH, MALAYSIA
25276 A II 9/8/2011 BAXTER HEALTHCARE CORP MESNA, USP/EP DRUG SUBSTANCE AS MANUFACTURED IN BIELEFELD AND
HALLE/WESTFALEN, GERMANY FOR BAXTER HEALTHCARE CORPORATION
25277 A III 8/30/2011 CELGARD LLC CELGARD 2300 SERIES TRANSDERMAL FLAT SHEET MEMBRANE AS MANUFACTURED IN
CHARLOTTE, NORTH CAROLINA
25278 A III 10/6/2011 PLASTITEC SA PVC BAGS AND ITS COMPONENTS FOR PHARMACEUTICAL SOLUTIONS (ESUB) AS
MANUFACTURED IN BOGOTA, COLOMBIA
25279 A II 3/30/2012 JUBILANT LIFE SCIENCES LTD LEVOCETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25280 A II 9/12/2011 HETERO DRUGS LTD DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25281 A II 9/6/2011 HETERO DRUGS LTD RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25282 A II 9/8/2011 PHARMACEUTICAL WORKS POLPHARMA SA DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
25283 A II 8/31/2011 OLON SPA OTILONIUM BROMIDE AS MANUFACTURED IN GARBAGNATE MILANESE (MI), AND DORNO
(PV), ITALY
25284 A III 9/6/2011 ELIX POLYMERS SL ELIX ABS M205FC, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN
25285 P *** PENDING FILING REVIEW ***
Page 756
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25286 A II 5/9/2012 CHATTEM CHEMICALS INC METHADONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN CHATTANOOGA, TN
25287 A II 9/9/2011 SANOFI AVENTIS SPA RIFAMYCIN SODIUM AS MANUFACTURED IN BRINDISI, ITALY
25288 A III 9/6/2011 ELIX POLYMERS SL ELIX ABC M203FC, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN
25289 A II 9/12/2011 CATALENT PHARMA SOLUTIONS LLC AMR101 1G CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FLORIDA
25290 P *** PENDING FILING REVIEW ***
25291 P *** PENDING FILING REVIEW ***
25292 A III 9/7/2011 ADVANCED FILMS LLC MEDICAL POUCH FILM, PRODUCT CODE F-19 AS MANUFACTURED IN RICHMOND, BC,
CANADA FOR ADVANCED FILMS, LLC
25293 A III 8/11/2011 TRUDELL MEDICAL INTERNATIONAL TOP MOUNT ACTUATION INDICATOR AS MANUFACTURED IN ONTARIO, CANADA
25294 A II 9/7/2011 FUJIAN SOUTH PHARMACEUTICAL CO LTD 10-DEACETYL-BACCATIN III (10-DAB III) (NON-STERILE) AS MANUFACTURED IN FUJIAN
PROVINCE, P. R. OF CHINA
25295 A II 9/7/2011 FUJIAN SOUTH PHARMACEUTICAL CO LTD DOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED
IN FUJIAN PROVINCE, P. R. OF CHINA
25296 A II 9/12/2011 HETERO DRUGS LTD NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25297 A II 9/13/2011 HETERO DRUGS LTD ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25298 A II 9/11/2011 HIKMA PHARMACEUTICALS GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN AMMAN, JORDAN
25299 A III 10/20/2011 WEENER EMPIRE PLASTICS LTD PLASTIC CLOSURES (ESUB) AS MANUFACTURED IN MAHARASHTRA STATE, INDIA
25300 A II 9/13/2011 DISHMAN NETHERLAND B.V. PARICALCITOL AS MANUFACTURED IN BE VEENENDAAL, THE NETHERLANDS
25301 A II 9/22/2011 INDOCO REMEDIES LTD BETAXOLOL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25302 A II 8/16/2011 VITAL HEALTH CARE PVT LTD NIMESULIDE AS MANUFACTURED IN GIDC VAPI, INDIA
25303 A II 9/15/2011 QILU ANTIBIOTICS PHARMACEUTICAL CO
LTD
CEFEPIME FOR INJECTION AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
25304 A II 9/13/2011 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN SHANGHAI, CHINA
25305 A II 9/13/2011 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
ATOVAQUONE AS MANUFACTURED IN SHANGHAI, CHINA
25306 A II 6/9/2011 VITAL HEALTH CARE PVT LTD ARTEMETHER AS MANUFACTURED IN GIDC VAPI, INDIA
25307 A III 9/12/2011 AMPACET CORP 412978 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE,
IN AND DERIDDER, LA AND CARTERSVILLE, GA AND HEATH, OH
25308 A II 10/3/2011 IND SWIFT LABORATORIES LTD ANASTROZOLE USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
25309 A II 9/20/2011 CHEMO IBERICA SA RABEPRAZOLE SODIUM (PROCESS II) AS MANUFACTURED IN MADRID, SPAIN
25310 P *** PENDING FILING REVIEW ***
25311 A II 11/2/2011 AMOLI ORGANICS PVT LTD SILDENAFIL CITRATE FORM-I (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
25312 A II 10/14/2011 CRESTONE INC CRS3123 (ESUB) AS MANUFACTURED IN MENLO PARK, CA FOR CRESTONE, INC.
25313 P *** PENDING FILING REVIEW ***
25314 A II 10/3/2011 CADILA HEALTHCARE LTD ERLOTINIB HYDROCHLORIDE (FORM-B) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25315 A II 11/23/2011 APICORE LLC BROMFENAC SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
25316 A II 9/22/2011 FINE CHEMICALS CORP PTY LTD SCOPOLAMINE (HYOSCINE) AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA
25317 A II 9/21/2011 INTAS PHARMACEUTICALS LTD DECITABINE AS MANUFACTURED IN STATE-GUJARAT, INDIA
25318 A II 9/12/2011 MANGALAM DRUGS AND ORGANICS LTD FUROSEMIDE USP AS MANUFACTURED IN GUJARAT, INDIA
25319 A II 8/22/2011 NEWCHEM SPA BUDESONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY
Page 757
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25320 A II 10/25/2011 SUN PHARMACEUTICAL INDUSTRIES LTD RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25321 A II 10/24/2011 EMCURE PHARMACEUTICALS LTD MEMANTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25322 A V 12/14/2011 CORDEN PHARMA LATINA SPA ASEPTIC PENICILLIN FACILITY (ESUB) AS MANUFACTURED IN SERMONETA (LATINA),
ITALY
25323 A II 9/27/2011 LEK PHARMACEUTICALS DD MYCOPHENOLATE MOFETIL (PROCESS B) AS MANUFACTURED IN MENGES, SLOVENIA
25324 A II 9/19/2011 BACHEM SA BRINZOLAMIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND
25325 A II 10/21/2011 DR REDDYS LABORATORIES EU LTD 20 KDA METHOXYPOLY(ETHYLENE GLYCOL)-4-NITROPHENYL CARBONATE (ESUB) AS
MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM
25326 A II 9/28/2011 SANGROSE LABORATORIES PVT LTD CLOFAZIMINE AS MANUFACTURED IN MAVELIKARA KERALA, INDIA
25327 A II 9/24/2011 MSN LABORATORIES LTD ALMOTRIPTAN MALATE [ROUTE CODE - AM] [NON-STERILE DRUG SUBSTANCE] (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
25328 A II 10/21/2011 DR REDDYS LABORATORIES LTD PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25329 A IV 9/21/2011 NIPPON FINE CHEMICAL CO LTD N-(CARBONYL-METHOXYPOLYETHYLENEGLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE,SODIUM SALT (MPEG2000-DSPE) AS MANUFACTURED IN
HYOGO, JAPAN
25330 A IV 9/21/2011 NIPPON FINE CHEMICAL CO LTD 1-STEAROYL-LYSOPHOSPHATIDYLCHOLINE (1-STEPC) AS MANUFACTURED IN HYOGO,
JAPAN
25331 A II 9/14/2011 ASAHI KASEI FINECHEM CO LTD TRANEXAMIC ACID USP AS MANUFACTURED IN MIYAZAKI, JAPAN
25332 A IV 9/16/2011 SAMSUNG FINE CHEMICALS CO LTD HYPROMELLOSE PHTHALATE AS MANUFACTURED IN INCHEON, REPUBLIC OF KOREA
25333 A IV 9/16/2011 SAMSUNG FINE CHEMICALS CO LTD HYPROMELLOSE AS MANUFACTURED IN INCHEON, REPUBLIC OF KOREA
25334 A II 10/3/2011 ALP PHARM BEIJING CO LTD LEUCOVORIN CALCIUM AS MANUFACTURED IN ZHEJIANG, CHINA FOR ALP PHARM
BEIJING CO., LTD.
25335 A II 10/3/2011 CENTAUR PHARMACEUTICALS PRIVATE LTD CHLORDIAZEPOXIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25336 A II 10/3/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MYCOPHENOLATE MOFETIL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25337 A II 10/3/2011 XINJIANG NUZILINE BIO PHARMACEUTICAL
CO LTD
CONJUGATED ESTROGENS AS MANUFACTURED IN XINJIANG PROVINCE, CHINA
25338 I II 9/28/2011 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1) AS
MANUFACTURED IN ZHEJIANG, CHINA
25339 A II 10/3/2011 AIR LIQUIDE HEALTHCARE AMERICA CORP 800 PPM NITROGEN DIOXIDE BALANCE AIR AS MANUFACTURED IN PLUMSTEADVILLE, PA
25340 A II 10/3/2011 MEIJI SEIKA PHARMA CO LTD ARBEKACIN SULFATE DRUG SUBSTANCE AS MANUFACTURED IN IWATE, JAPAN
25341 A II 10/3/2011 QUESTCOR PHARMACEUTICALS INC H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION) AS MANUFACTURED IN
BALTIMORE, MD FOR QUESTCOR PHARMACEUTICALS, INC
25342 A II 10/3/2011 CHEMPORT INC OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN JEOLLANAM-DO, SOUTH KOREA
25343 A II 10/4/2011 MYLAN LABORATORIES LTD VORICONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25344 A II 10/4/2011 HETERO LABS LTD TEMOZOLOMIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25345 A II 10/14/2011 CRESTONE INC CRS3123-2HCL (ESUB) AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE FOR
CRESTONE, INC
25346 A II 11/4/2011 AMOLI ORGANICS PVT LTD ATORVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN GUJARAT STATE, INIDA
25347 A II 10/5/2011 VALDEPHARM STERILE ARIPIPRAZOLE MONOHYDRATE AS MANUFACTURED IN VAL DE REUIL, FRANCE
25348 A II 10/24/2011 CADILA HEALTHCARE LTD DESVENLAFAXINE BASE (ESUB) AS MANUFACTURED IN STATE: GUJARAT, INDIA
Page 758
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25349 A II 10/18/2011 KERRY BIOFUNCTIONAL INGREDIENTS INC
DBA KERRY BIO SCIENCE
DISINTEQUIK ODT AS MANUFACTUED IN NORWICH, NY
25350 I III 10/4/2011 HUAYI ISOTOPES CORP MX CASSETTES AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
25351 A III 10/4/2011 NYPRO INC MDI ACTUATOR/ DOSE COUNTER ASSEMBLY AS MANUFACTURED IN COUNTY DUBLIN,
IRELAND FOR NYPRO INC
25352 A III 10/4/2011 NYPRO INC CONCEPT ONE DRY POWDER INHALER AS MANUFACTURED IN FONTENAY SUR EURE,
FRANCE FOR NYPRO INC
25353 A III 10/5/2011 AMPACET CORP 112761 WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; CARTERSVILLE, GA;
HEATH, OH; DERIDDER ,LA
25354 A II 10/5/2011 MEGAFINE PHARMA P LTD BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
DIST. NASHIK, INDIA
25355 A II 10/5/2011 AMI LIFE SCIENCES PRIVATE LTD TADALAFIL AS MANUFACTURED IN STATE GUJARAT, INDIA
25356 A II 10/5/2011 MSN LABORATORIES LTD AZELASTINE HYDROCHLORIDE [ROUTE CODE: AH] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25357 I II 11/3/2011 USV LIMITED SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25358 A II 10/6/2011 SMS PHARMACEUTICALS LTD SILDENAFIL CITRATE (UNIT-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25359 A III 10/6/2011 AMPACET CORP 169240 BLUE/HR POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE
HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH
25360 A II 10/6/2011 LABORATORIOS IMPERIALES SA DE CV BISMUTH SUBSALICYLATE AS MANUFACTURED IN MORELOS, MEXICO
25361 A II 11/16/2011 UNIMARK REMEDIES LTD BUSPIRONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25362 A II 10/25/2011 UNIMARK REMEDIES LTD MOXIFLOXACIN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25363 A II 10/6/2011 SCI PHARMTECH INC (+)-THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID. HCI (5TC) AS MANUFACTURED IN
TAOYUAN, TAIWAN
25364 A II 10/7/2011 CENTAUR PHARMACEUTICALS PRIVATE LTD TEMAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25365 A II 10/7/2011 ALEMBIC PHARMACEUTICALS LTD NISOLDIPINE AS MANUFACTURED IN GUJARAT, INDIA
25366 A II 10/7/2011 MAPRIMED SA RASAGILINE MESYLATE (CODE 50855) AS MANUFACTURED IN BUENOS AIRES,
ARGENTINA
25367 A II 10/28/2011 MALLINCKRODT INC PARACETAMOL DC 272N (GELATIN) (ESUB) AS MANUFACTURED IN GREENVILE, ILLINOIS
25368 A II 10/3/2011 ALP PHARM BEIJING CO LTD MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
FOR ALP PHARM BEIJING CO., LTD.
25369 A IV 9/30/2011 UNGERER AND CO ARTIFICIAL ROSE FLAVOR FU-6326 AS MANUFACTURED IN BETHLEHEM, PA
25370 A II 10/3/2011 IBA MOLECULAR NORTH AMERICA INC 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE AS MANUFACTURED IN TOTOWA, NJ
25371 A II 10/11/2011 GE HEALTHCARE INC FASTLAB FDG CITRATE CASSETTE PACK AS MANUFACTURED IN LIEGE, BELGIUM FOR
GE HEALTHCARE INC
25372 A II 10/11/2011 SANDOZ PRIVATE LTD DORIPENEM MONOHYDRATE, STERILE AS MANUFACTURED IN MAHARASHTRA, INDIA
25373 A II 10/11/2011 ALEMBIC PHARMACEUTICALS LTD FELODIPINE USP AS MANUFACTURED IN GUJARAT, INDIA
25374 A III 10/11/2011 INDIAN EXTRUSIONS HDPE BOTTLES WITH CAPS AS MANUFACTURED IN DAMAN, INDIA
25375 A III 2/10/2012 RADPHARM SCIENTIFIC, A DIVISION OF
GLOBAL MEDICAL SOLUTIONS
RADPHARM GAMMA STERILIZED EMPTY VIALS 10ML, 20ML AND 30ML(ESUB) AS
MANUFACTURED IN BELCONNEN, AUSTRALIA FOR RADPHARM SCIENTIFIC, A DIVISION
OF GLOBAL MEDICAL SOLUTIONS
25376 A III 10/12/2011 AMPACET CORP 154313 RED PE MB AS MANUFACTURED IN GRAND DUCHE DE, LUXEMBOURG FOR
AMPACET CORPORATION
25377 A IV 10/12/2011 ABELEI INC PRODUCT #174A95 NAT. & ART. MINT FLAVOR POWDER AS MANUFACTURED IN NORTH
AURORA, IL
Page 759
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25378 A II 10/12/2011 QILU PHARMACEUTICAL CO LTD ROPIVACAINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE, P. R. OF CHINA
25379 A IV 10/12/2011 MEXICHEM UK LTD INHALATION GRADE 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE FOR USE IN METERED DOSE
INHALERS AS MANUFACTURED IN EL DORADO, AR FOR MEXICHEM UK LTD
25380 A II 10/13/2011 CENTAUR PHARMACEUTICALS PRIVATE LTD NORTRIPTYLINE HCI USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25381 A II 10/13/2011 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN HEBEI PROVINCE, THE P. R. OF
CHINA
25382 A II 10/13/2011 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
CHOLESTEROL HP AS MANUFACTURED IN GUJARAT, INDIA
25383 A III 10/13/2011 TEKNOR COLOR CO 040,121TCS FDA TR BLUE 2% AS MANUFACTURED IN HENDERSONK, KY AND
JACKSONVILLE, TX
25384 A III 4/30/2012 SHRIJI POLYMERS INDIA LTD HIGH PERFORMANCE BOTTLES (ESUB)
25385 A II 10/14/2011 CHEMI SPA MESALAMINE CRYSTALLIZED, USP AS MANUFACTURED IN FROSINONE, ITALY
25386 A III 10/14/2011 3M DRUG DELIVERY SYSTEMS SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (SMTS) ARRAY FOR BA058-SMTS AS
MANUFACTURED IN ST. PAUL, MN AND FLORENCE, KY FOR 3M DRUG DELIVERY
SYSTEMS
25387 A II 10/14/2011 FRESENIUS KABI ANTI INFECTIVES SRL BUFFERED NAFCILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY
25388 A III 12/2/2011 WOLFE TORY MEDICAL, INC. VAXINATOR ATOMIZATION TIP AS MANUFACTURED IN SALT LAKE CITY, UT
25389 A II 10/17/2011 PIRAMAL ENTERPRISES LTD ACYCLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25390 A II 10/17/2011 CSPC ZHONGNUO PHARMACEUTICAL
SHIJIAZHUANG CO LTD
CEFIXIME NON-STERILE AS MANUFACTURED IN HEBEI PROVINCE, CHINA
25391 A V 10/17/2011 MEDISIZE CORP INSERTER FOR LNG IUS 13.5 MG AS MANUFACTURED IN LEHMO, FINLAND FOR MEDISIZE
CORPORATION
25392 A III 10/17/2011 UPM RAFLATAC OY RP 31 PURUS AS MANUFACTURED IN TAMPERE, FINLAND
25393 A II 10/18/2011 EUTICALS SPA BUSULFAN AS MANUFACTURED IN VARESE, ITALY
25394 A II 10/18/2011 EUTICALS SPA BENDAMUSTINE HYDROCHLORIDE HYDRATE AS MANUFACTURED IN VARESE, ITALY
25395 A IV 10/18/2011 UNGERER AND CO N/A FRUIT TOPNOTE FLAVOR FU-6558 AS MANUFACTURED IN BETHLEHEM, PA
25396 A III 10/18/2011 AMPACET CORP 183538 BROWN PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25397 A IV 10/18/2011 UNGERER AND CO NATURAL ORANGE WONF FLAVOR FU-6556 AS MANUFACTURED IN BETHLEHEM, PA
25398 A IV 10/18/2011 UNGERER AND CO N/A CREAM FLAVOR FU-6557 AS MANUFACTURED IN BETHLEHEM, PA
25399 A II 11/7/2011 GLAND CHEMICALS PRIVATE LTD PEMETREXED DISODIUM 2.5 HYDRATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25400 A II 11/3/2011 GLAND PHARMA LTD ARGATROBAN MONOHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25401 A II 11/4/2011 GLAND PHARMA LTD INDOMETHACIN SODIUM USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25402 A II 10/20/2011 MEGAFINE PHARMA P LTD MEMANTINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
DIST. NASHIK, INDIA
25403 A IV 8/1/2011 BHARAT COATS PROTECTAB EC-1, PROTECTAB HP-1(ORGANIC), PROTECTAB HP-1 (AQUEOUS) AND
PROTECTAB MB-1 AS MANUFACTURED IN TAMILNADU, INDIA
25404 I II 10/20/2011 JOYANG LABORATORIES BACITRACIN USP AS MANUFACTURED IN JIANGSU, CHINA
25405 A II 10/20/2011 CHANGZHOU RUIMING PHARMACEUTICAL
CO LTD
FELODIPINE AS MANUFACTURED IN JIANGSU, CHINA
25406 A II 10/21/2011 JINAN JINDA PHARMACEUTICAL CHEMISTRY
CO LTD
CIDOFOVIR DIHYDRATE AS MANUFACTURED IN SHANDONG, CHINA
Page 760
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25407 A III 10/21/2011 NOVAPET SA NOVAPET CR POLYESTER RESIN AS MANUFACTURED IN BARBASTRO(HUESCA), SPAIN
25408 A IV 10/21/2011 FMC CORP FMC BIOPOLYMER DIV ALUBRA SODIUM STEARYL FUMARATE AS MANUFACTURED IN QUAKERTOWN, PA AND
DIST. RAIGAD, INDIA FOR FMC CORPORATION
25409 A III 10/21/2011 LUCAS PACKAGING GROUP AIRLESS METERED DOSE (AMD) PEN AS MANUFACTURED IN REEDSVILLE, PA FOR
LUCAS PACKAGING GROUP
25410 A II 10/24/2011 MACLEODS PHARMACEUTICALS LTD ENTACAPONE AS MANUFACTURED IN GUJARAT, INDIA
25411 A II 10/24/2011 HETERO LABS LTD HYDRALAZINE HYDROCHLORIDE, USP (PARENTERAL GRADE) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25412 A II 10/24/2011 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1) AS MANUFACTURED IN
ZHEJIANG, CHINA
25413 A IV 10/24/2011 TAKASAGO INTERNATIONAL CORP TAK-100176 MICRON? NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN
TETERBORO, NJ
25414 A IV 10/24/2011 TAKASAGO INTERNATIONAL CORP TAK-081662 MICRON? NATURAL & ARTIFICIAL COOL PEPPERMINT FLAVOR AS
MANUFACTURED IN TETERBORO, NJ
25415 A IV 10/24/2011 TAKASAGO INTERNATIONAL CORP TAK-100094 MICRON? NATURAL & ARTIFICIAL CITRUS FLAVOR AS MANUFACTURED IN
TETERBORO, NJ
25416 A IV 10/25/2011 IDEAL CURES PVT LTD ESPHERES NEUTRAL PELLETS AS MANUFACTURED IN JAMMU & KASHMIR, INDIA
25417 A II 10/26/2011 LAB EXPRESS INTERNATIONAL INC CHLORHEXIDINE GLUCONATE SOLUTION USP 20% AS MANUFACTURED IN FAIRFIELD, NJ
25418 A II 10/26/2011 SYMED LABS LTD MECLIZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25419 P *** PENDING FILING REVIEW ***
25420 A II 11/22/2011 OCEAN NUTRITION CANADA LTD HIGH EPA INTERMEDIATE FISH OIL (ESUB) AS MANUFACTURED IN NOVA SCOTIA,
CANADA
25421 A II 3/1/2012 EXCELLA GMBH DEFEROXAMINE MESYLATE USP(ESUB) AS MANUFACTURED IN FEUCHT, GERMANY
25422 A IV 10/26/2011 FONA INTERNATIONAL INC 815.0020U BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
25423 A III 10/26/2011 TEKNOR COLOR CO 43,777HCP BLUE 25:1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX
25424 A II 11/3/2011 AUROBINDO PHARMA LTD SILDENAFIL CITRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25425 A II 11/28/2011 DR REDDYS LABORATORIES LTD LINEZOLID (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25426 A II 10/28/2011 HETERO DRUGS LTD SERTRALINE HYDROCHLORIDE, USP (FORM 1) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25427 A II 1/3/2012 AMOLI ORGANICS PVT LTD CELECOXIB (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
25428 A V 10/26/2011 WEST PHARMACEUTICAL SERVICES INC WESTAR READY-TO-USE (RU) GAMMA IRRADIATED ELASTOMERS AS MANUFACTURED IN
JERSEY SHORE, PA FOR WEST PHARMACEUTICAL SERVICES, INC
25429 A IV 10/28/2011 ABELEI INC 113A68 NATURAL & ARTIFICIAL BERRY TYPE FLAVOR POWDER AS MANUFACTURED IN
NORTH AURORA, IL
25430 A IV 10/28/2011 ABELEI INC 144A147 NATURAL & ARTIFICIAL TROPICAL TYPE FLAVOR POWDER AS MANUFACTURED
IN NORTH AURORA, IL
25431 A III 10/28/2011 POLYCINE GMBH APP147 AS MANUFACTURED IN SCHIFFWEILER, GERMANY
25432 A III 9/22/2011 EXTRAL SA DE CV ALUMINUM BARRIER LAMINATION (ABL) AND PLASTIC BARRIER LAMINATION (PBL)
IMPRESSION AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO
25433 A II 12/29/2011 EMCURE PHARMACEUTICALS LTD BUSULFAN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25434 A II 12/31/2011 SUN PHARMACEUTICAL INDUSTRIES LTD SEVELAMER HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25435 I II 12/6/2011 RELIANCE LIFE SCIENCES PVT LTD LOTEPREDNOL ETABONATE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INIDA
Page 761
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25436 A II 10/31/2011 AVANTI POLAR LIPIDS INC 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PROCESS II (DSPC II) AS
MANUFACTURED IN ALABASTER, ALABAMA
25437 A III 10/31/2011 SIBO G DOO CONTAINERS SIBO AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA
25438 A IV 10/31/2011 SEPPIC SA MONTANE 20 PPI AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S. A.
25439 A III 10/31/2011 BRUNA SEALS LLC CLOSURE LINERS AS MANUFACTURED IN MIAMI, FLORIDA
25440 A II 10/31/2011 MAC CHEM PRODUCTS INDIA PVT LTD SUCCINYLCHOLINE CHLORIDE USP AS MANUFACTURED IN DISTRICT THANE, INDIA
25441 A III 10/31/2011 ESSEL PROPACK LTD LAMINATED TUBES (MURBAD UNIT) AS MANUFACTURED IN DIST. THANE MAHARASHTRA,
INDIA
25442 A III 10/11/2011 SANDLER AG NONWOVEN SAWABOND 4163 AS MANUFACTURED IN SCHWARZENBACH/SAALE,
GERMANY
25443 A II 11/28/2011 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
CEFEPIME HCI USP (ESUB) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA
25444 A II 12/20/2012 GLAXOSMITHKLINE LLC CLOBETASOL PROPIONATE (ESUB) AS MANUFACTURED IN MONTROSE, UK FOR
GLAXOSMITHKLINE LLC
25445 P *** PENDING FILING REVIEW ***
25446 A II 11/14/2011 CADILA HEALTHCARE LTD IRBESARTAN USP (ESUB) AS MANUFACTURED IN STATE: GUJARAT, INDIA
25447 A II 2/8/2012 CADILA HEALTHCARE LTD DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA
25448 A II 11/2/2011 SYMBIOTEC PHARMALAB LTD MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN INDORE (M.P.), INDIA
25449 A IV 11/2/2011 CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, ATEVA? K2356.XO1 AS MANUFACTURED IN
ALBERTA, CANADA
25450 I V 11/1/2011 ROTEM INDUSTRIES LTD DISPOSABLE CASSETTE FOR VIAL FILLER SYSTEM AS MANUFACTURED IN BEER-SHEVA,
ISRAEL
25451 A III 11/2/2011 AMPACET CORP 100665 MOLD RELEASE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEALTH, OH
25452 A III 11/2/2011 AMPACET CORP 122103 SILVER PEARL PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEALTH, OH
25453 A III 11/2/2011 AMPACET CORP 169617 PEARL VIOLET PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEALTH , OH
25454 A II 12/16/2011 CHEMSPEC API MENADIOL SODIUM DIPHOSPHATE (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ
25455 A II 11/3/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
CANDESARTAN CILEXETIL AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. OF CHINA
25456 A II 11/3/2011 VASUDHA PHARMA CHEM LTD CYPROHEPTADINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25457 A II 11/3/2011 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
PENTETIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
PHARMA INC
25458 A III 11/3/2011 GIL PLASTIC PRODUCTS LTD PLASTIC JARS AND BOTTLES AS MANUFACTURED IN ASHDOD, ISRAEL
25459 A IV 11/3/2011 CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, ATEVA+F25369 K2357.X01 AS MANUFACTURED
IN ALBERTA, CANADA
25460 A II 11/16/2011 JUBILANT HOLLISTERSTIER LLC STERILE EMPTY VIALS (ESUB) AS MANUFACTURED IN SPOKANE, WA
25461 A II 10/20/2011 CHENG FONG CHEMICAL CO LTD PROCAINAMIDE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN
25462 A II 12/14/2011 PAR PHARMACEUTICAL INC PIMOZIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR
PHARMACEUTICAL, INC
25463 A IV 11/4/2011 CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE K2418.X01 AS MANUFACTURED IN
ALBERTA, CANADA
25464 A II 11/4/2011 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
CLOPIDOGREL BISULFATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25465 A II 11/4/2011 KEKULE PHARMA LTD NILUTAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 762
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25466 A II 11/4/2011 SYN TECH CHEM AND PHARM CO LTD TOLPERISONE HYDROCHLORIDE AS MANUFACTURED IN TAINAN CITY, TAIWAN
25467 A II 11/4/2011 EXEMED PHARMACEUTICALS METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA
25468 I II 11/4/2011 HUAYI ISOTOPES CO RK-100 AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
25469 I II 11/4/2011 HUAYI ISOTOPES CO OXYGEN-18 WATER AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
25470 A II 11/29/2011 ARCH PHARMALABS LTD CLOPIDOGREL CAMPHOR SULPHONATE SALT (ESUB) AS MANUFACTURED IN HARYANA,
INDIA FOR ARCH PHARMALABS LIMITED
25471 A III 3/22/2012 PADMA POLYTEX INDIA PVT LTD PLASTIC POUCHES (POLY BAGS) (ESUB) AS MANUFACTURED IN UJJAIN,(M.P.) INDIA
25472 A II 1/10/2012 MACLEODS PHARMACEUTICALS LTD ARIPIPRAZOLE (ESUB) AS MANUFACTURED IN GUJRAT, INDIA
25473 A III 11/10/2011 METALCO S.R.L. ALUMINUM CONTAINERS FOR BULK DRUGS SUBSTANCES AS MANUFACTURED IN
MONTECARLO (LU), ITALY
25474 I II 11/8/2011 FINORGA SAS FENOFIBRATE AS MANUFACTURED IN MOURENX, FRANCE
25475 A IV 11/7/2011 PHOSPHOLIPID GMBH PHOSAL+F25451 35 SB AS MANUFACTURED IN COLOGNE, GERMANY
25476 A III 11/10/2011 FUJIMORI KOGYO CO LTD RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES ** E-0010
GT AS MANUFACTURED IN SHIZUOKA PREF., JAPAN
25477 A II 11/10/2011 FRESENIUS KABI ANTI INFECTIVES SRL AMPICILLIN SODIUM/SULBACTAM SODIUM AS MANUFACTURED IN VILLADOSE (RO), ITALY
25478 A II 11/10/2011 ICROM SPA BRINZOLAMIDE (MICRONIZED AND NON MICRONIZED, STERILE AND NON STERILE) AS
MANUFACTURED IN CONCOREZZO, ITALY
25479 A II 11/4/2011 MEISSNER FILTRATION PRODUCTS INC FLUOROFLEX BIOCONTAINERS AS MANUFACTURED IN CAMARILLO, CA
25480 A III 11/10/2011 AURIGA POLYMERS INC POLYETHYLENE TEREPHTHALATE RESINS, SPARTANBURG, SC
25481 I II 11/10/2011 DERIVADOS QUIMICOS SA DIOXANONE AS MANUFATURED IN MURCIA (SPAIN)
25482 A II 11/9/2011 HETERO LABS LTD BORTEZOMIB (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25483 A II 11/9/2011 TEVA PHARMACEUTICAL INDUSTRIES LTD IRBESARTAN (ESUB) AS MANUFACTURED IN MALANPUR AND GAJRAULA, INDIA FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD.
25484 A II 12/6/2011 EMCURE PHARMACEUTICALS LTD ANASTROZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25485 A III 11/9/2011 PG FOILS LTD PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN RAJASTHAN, INDIA
25486 A II 11/9/2011 TOYOX CO LTD TOYOX SILICONE HOSE SERIES AS MANUFACTURED IN TOYAMA-PREF., JAPAN FOR
TOYOX COMPANY LTD.
25487 A III 11/9/2011 JIANGSU CHAOHUA GLASSWORK CO LTD CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF NEUTRAL-BOROSILICATE
GLASS (TYPE I, USP) TUBING, DANYANG CITY, P.R. CHINA
25488 I II 12/23/2011 PHF SA SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN VICENZA, ITALY FOR PHF SA
25489 A III 11/9/2011 JIANGSU CHAOHUA GLASSWORK CO LTD CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF LOW-BOROSILICATE GLASS
TUBING ( TYPEI, USP) DANYANG CITY, P.R CHINA
25490 A II 11/9/2011 AVANTI POLAR LIPIDS INC 1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PROCESS II (DMPC II) AS
MANUFACTURED IN ALABASTER, AL
25491 A II 12/8/2011 SHILPA MEDICARE LTD BUSULFAN USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25492 A II 11/14/2011 APOTEX PHARMACHEM INDIA PVT LTD LINEZOLID AS MANUFACTURED IN BANGALORE, INDIA
25493 A II 11/14/2011 APOTEX PHARMACHEM INDIA PVT LTD LANSOPRAZOLE USP AS MANUFACTURED IN BANGALORE, INDIA
25494 A II 11/14/2011 APOTEX PHARMACHEM INDIA PVT LTD OLMESARTAN MEDOXOMIL AS MANUFACTURED IN BANGALORE, INDIA
25495 A II 11/14/2011 INTAS PHARMACEUTICALS LTD DOCETAXEL ANHYDROUS(ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25496 A II 1/3/2012 PIRAMAL HEALTHCARE UK LTD SPIRONOLACTONE USP (ESUB) AS MANUFACTURED IN NORTHUMBERLAND, ENGLAND
25497 A II 12/22/2011 CHEMSPEC-API ISOCARBOXAZID (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ
25498 A II 11/14/2011 GLOCHEM INDUSTRIES LTD LEVODOPA AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25499 A II 11/14/2011 HANGZHOU ZHONGMEI HUADONG
PHARMACEUTICAL CO LTD
PANTOPRAZOLE SODIUM AS MANUFACTURED IN HANGZHOU, CHINA
Page 763
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25500 A III 11/14/2011 PFP TERMOPOLIMEROS SL BOTE 1500ML HDPE/BO-TE US AS MANUFACTURED IN BARCELONA, SPAIN
25501 A II 11/14/2011 SUNBIO, INC. METHOXY POLYETHYLENE GLYCOL BENZOTRIAZOLYL CARBONATE 20,000 AS
MANUFACTURED IN ANYANG CITY, S. KOREA
25502 A III 11/14/2011 CONSOLIDATED BOTTLE CORP 1" X 2" NATURAL PP VIAL PRINTED WITH LINE - BLUE" AS MANUFACTURED IN ONTARIO,
CANADA FOR CONSOLIDATED BOTTLE CORPORATION
25503 A II 12/20/2011 ALEMBIC PHARMACEUTICALS LTD ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25504 A II 6/3/2011 SANOFI AVENTIS DEUTSCHLAND GMBH PREDNICARBATE AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY
25505 A II 11/16/2011 BD BIOSCIENCES ADVANCED
BIOPROCESSING
BD RECHARGE WITHOUT GLUCOSE AND L-GLUTAMINE AS MANUFACTURED IN MIAMI, FL;
SPARKS, MD AND SARANAC LAKE, NY FOR BD BIOSCIENCE ADVANCED BIOPROCESSING
25506 A II 11/17/2011 DISHMAN PHARMACEUTICALS AND
CHEMICALS LIMITED
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE, AHMEDABAD, GUJARAT, INDIA
25507 A II 11/18/2011 SIEGFRIED USA LLC BUPRENORPHINE HYDROCHLORIDE, PENNSVILLE, NEW JERSEY
25508 A II 11/18/2011 IROKO PHARMACEUTICALS LLC MELOXICAM SOLUMATRIX TM CAPSULES (6 MG), AS MANUFACTURED IN KANSAS CITY,
MO FOR ICEUTICA OPERATIONS LLC
25509 A II 11/18/2011 ZHUHAI RUNDU PHARMACEUTICAL CO LTD IRBESARTAN, GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA
25510 A II 11/18/2011 ZHUHAI RUNDU PHARMACEUTICAL CO LTD VALSARTAN, GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA
25511 A II 11/18/2011 JIANGSU HENGRUI MEDICINE CO LTD CISATRACURIUM BESYLATE, NON-STERILE, BULK DRUG SUBSTANCE, JIANGSU
PROVINCEM, CHINA
25512 A II 11/21/2011 HERAEUS PRECIOUS METALS GMBH AND
CO KG
BENDAMUSTINE HYDROCHLORIDE, HANAU, GERMANY
25513 A II 11/22/2011 MSN ORGANICS PVT LTD TADALAFIL [ROUTE CODE - "TD"] [NON-STERILE DRUG SUBSTANCE] AS MANUFACTURED
IN ANDHRA PRADESH, INDIA
25514 A II 11/22/2011 SMS PHARMACEUTICALS LTD ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25515 A III 11/22/2011 AGUA FARMA PLASTICOS SA DE CV HDPE & LDPE BOTTLES AS MANUFACTURED IN JALISCO, MEXICO FOR AGUA FARMA
PLASTICOS, S.A DE C.V.
25516 A III 11/22/2011 HBR PACKAGING ALUMINIUM VIAL SEALS AS MANUFACTURED IN THANE, INDIA
25517 A II 12/6/2011 AUROBINDO PHARMA LTD ATAZANAVIR SULFATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25518 A III 11/22/2011 CHROMA CORP PC57088 PURPLE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS
25519 A II 11/23/2011 WUXI JIDA PHARMACEUTICAL CO LTD ESCITALOPRAM OXALATE AS MANUFATCURED IN JIANGSU PROVINCE, CHINA
25520 A V 3/25/2011 IONISOS IBERICA FACILITY AND PROCEDURES FOR ELECTRON BEAM STERILIZATION IN TARANCON, SPAIN
25521 I II 11/23/2011 JIANGSU HENGRUI MEDICINE CO LTD CAPECITABINE USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
JIANGSU, CHINA
25522 A III 11/23/2011 AMERICHEM INC 61936-CD2 TAN COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH
25523 A II 11/28/2011 ICROM SPA AMISULPRIDE AS MANUFACTURED IN CONCOREZZO, ITALY
25524 A II 11/28/2011 CHONGQING HUAPONT PHARMACEUTICAL
CO LTD
BENDAMUSTINE HCL, CHONGQING , P.R. CHINA
25525 A II 11/28/2011 PHYTON BIOTECH LLC PACLITAXEL PRODUCED BY PLANT CELL FERMENTATION USP, SAN ANTONIO, TX
25526 A II 11/28/2011 FRESENIUS KABI ANTI INFECTIVES SRL BUFFERED PENICILLIN G POTASSIUM STERILE, CERNUSCO SUL NAVIGILIO, ITALY
25527 A II 11/28/2011 ALEMBIC PHARMACEUTICALS LTD O-DESMETHYL VENLAFAXINE, GUJARAT, INDIA
25528 P *** PENDING FILING REVIEW ***
25529 P *** PENDING FILING REVIEW ***
25530 A II 12/8/2011 TORRENT PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
Page 764
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25531 A II 5/14/2012 CHENGDU SHENGNUO BIOPHARM CO LTD BIVALIRUDIN (NON-STERILE BULK DRUG) (ESUB) AS MANUFACTURED IN SICHUAN, CHINA
25532 A II 12/16/2011 FRESENIUS KABI ONCOLOGY LTD DECITABINE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA
25533 A II 11/30/2011 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
METAXALONE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25534 A II 11/30/2011 SYMBIOTEC PHARMALAB LTD TESTOSTERONE UNDECANOATE AS MANUFACTURED IN (M.P.), INDIA
25535 A II 11/30/2011 SYMBIOTEC PHARMALAB LTD TESTOSTERONE PROPIONATE, USP (MICRONIZED) AS MANUFACTURED IN (M.P.), INDIA
25536 A II 11/29/2011 DAEWOONG BIO INC URSODIOL(URSODEXOXYCHOLIC ACID) AS MANUFACTURED IN KYUNGGI-DO, KOREA
25537 A II 11/29/2011 SEIKAGAKU CORP SODIUM HYALURONATE AS MANUFACTURED IN KANAGAWA, JAPAN
25538 A II 12/6/2011 COSMA SPA GLICLAZIDE (ESUB) AS MANUFACTURED IN BERGAMO, ITALY
25539 A III 12/2/2011 POLIMERI EUROPA SPA RIBLENE MP 31 R AS MANUFACTURED IN FERRARA, ITALY
25540 A III 12/2/2011 POLIMERI EUROPA SPA RIBLENE MR 10 R AS MANUFACTURED IN FERRARA, ITALY
25541 A II 12/1/2011 FERMION OY OSPEMIFENE AS MANUFACTURED IN OULU, FINLAND
25542 A II 12/1/2011 DJADA PHARMACEUTICAL SA BEXAROTENE AS MANUFACTURED IN CHONGQING, CHINA FOR DJADA
PHARMACEUTICAL SA
25543 A II 12/1/2011 NEULAND LABORATORIES LTD EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25544 A II 12/1/2011 HIKMA PHARMACEUTICALS PLC MILRINONE, USP AS MANUFACTURED IN AMMAN, JORDAN
25545 A II 12/1/2011 FRESENIUS KABI ANTIINFECTIVES SRL PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED AS
MANUFACTURED IN CERNUSCO SUL NAVIGLIO, ITALY
25546 A II 12/1/2011 LG LIFE SCIENCES LTD MONTELUKAST SODIUM AS MANUFACTURED IN ULSAN, KOREA
25547 A II 12/2/2011 SYMBIOTEC PHARMALAB LTD FLUMETHASONE AS MANUFACTURED IN INDORE, INDIA
25548 A II 12/2/2011 ALPHORA RESEARCH INC TREPROSTINIL SODIUM AS MANUFACTURED IN ONTARIO, CANADA
25549 A II 12/2/2011 SCINOPHARM TAIWAN LTD ENTECAVIR MONOHYDRATE AS MANUFACTURED IN TAINAN, TAIWAN
25550 A II 12/2/2011 HETERO LABS LTD ETRAVIRINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25551 A V 12/2/2011 ROTEM INDUSTRIES LTD CASSETTE FOR THE PRODUCTION OF FLUORINE-18 SODIUM FLUORIDE ON THE
TRACERLAB MX SYNTHESIS UNIT AS MANUFACTURED IN BE'ER SHEVA, ISRAEL
25552 A II 12/5/2011 ZHEJIANG TIANYU PHARMACEUTICAL CO
LTD
TELMISARTAN METHYL ESTER AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25553 A IV 12/5/2011 LIPOID GMBH LIPOID SODIUM OLEATE B AS MANUFACTURED IN LUDWIQSHAFEN, GERMANY
25554 A III 12/5/2011 SUZHOU HAISHUN PACKAGING MATERIAL
CO LTD
LAMINATED FILMS AND POUCHES (PET/A1/PE) FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN SUZHOU, P.R. CHINA
25555 A III 12/5/2011 HANGZHOU PLASTICS INDUSTRIAL CO LTD PVC SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS MANUFACTURED IN
HANGZHOU, CHINA
25556 A II 12/27/2011 GLAND PHARMA LTD DALTEPARIN SODIUM PH.EUR. (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25557 A II 12/6/2011 SHARON BIO MEDICINE LTD NIFEDIPINE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA
25558 A III 12/7/2011 BORMIOLI ROCCO SPA BU PLASTICS DROPPER 1.00 MM AS MANUFACTURED IN CASTELGUELFO(PR),RIVANAZZANO, ITALY,
SAINT SULPICE, FRANCE
25559 A II 3/15/2012 RELIANCE LIFE SCIENCES PVT LTD PEMETREXED DISODIUM (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
25560 A II 12/22/2011 ALCHYMARS ICM SM PRIVATE LTD SODIUM PHENYLBUTYRATE AS MANUFACTURED IN TAMILNADU, INDIA
25561 A II 5/2/2012 NECTAR LIFESCIENCES LTD CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE (PROCESS-II) (ESUB) AS
MANUFACTURED IN PUNJAB, INDIA
25562 A IV 9/4/2012 NECTAR LIFESCIENCES LTD HARD GELATIN CAPSULE SHELL (PROCESS-II) (ESUB) AS MANUFACTURED IN DISTT.
SOLAN (H.P), INDIA
Page 765
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25563 A II 12/9/2011 GLOCHEM INDUSTRIES LTD CARBIDOPA AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25564 A II 12/8/2011 KOTHARI PHYTOCHEMICALS
INTERNATIONAL
METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MADURAI DISTRICT,
TAMILNADU, INDIA
25565 A II 12/6/2011 COPPERHEAD INVESTMENTS INC SDM12, DILUTED NITROGLYCERIN USP AS MANUFACTURED IN TAMAQUA,
PENNSYLVANIA FOR COPPERHEAD INVESTMENTS INC
25566 A IV 12/8/2011 FONA INTERNATIONAL INC 815.086 BUBBLEGUM FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL
25567 A II 12/8/2011 HETERO LABS LTD ATAZANAVIR SULFATE AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA
25568 A II 12/8/2011 NEULAND LABORATORIES LTD MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25569 A II 2/24/2012 LUPIN LTD FOSAMPRENAVIR CALCIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25570 A II 12/29/2011 NECTAR LIFESCIENCES LTD CEFDINIR USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
25571 A III 12/13/2011 YAMANI YAKUHIN CO LTD DRYEN SILICA GEL DESICCANT AS MANUFACTURED IN SHIGA, JAPAN
25572 A II 12/13/2011 HETERO DRUGS LTD APREPITANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25573 A II 12/12/2011 NORAC INC NGT-10100 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA
25574 A II 12/12/2011 SHANDONG FANGMING PHARMACEUTICAL
GROUP CO LTD
GLICLAZIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
25575 A III 12/12/2011 AMPACET CORP 111818-K BLOMITE 818 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET
CORPORATION
25576 A II 12/12/2011 QILU PHARMACEUTICAL CO LTD DOCETAXEL TRIHYDRATE AS MANUFACTURED IN SHANDONG P.R. CHINA
25577 A II 12/12/2011 MYLAN LABORATORIES LTD ILOPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25578 A II 12/12/2011 MYLAN LABORATORIES LTD FOSAMPRENAVIR CALCIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25579 A II 12/12/2011 MYLAN LABORATORIES LTD SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25580 A II 1/11/2012 PAR PHARMACEUTICAL INC PHENOXYBENZAMINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN
KARNATAKA, INDIA FOR PAR PHARMACEUTICAL INC
25581 A II 12/13/2011 ALEMBIC PHARMACEUTICALS LTD FAMOTIDINE USP AS MANUFACTURED IN GUJARAT, INDIA
25582 A II 12/14/2011 JIANGXI SYNERGY PHARMACEUTICAL CO
LTD
CELECOXIB AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA
25583 A II 12/13/2011 SMILAX LABORATORIES LTD PANTOPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25584 A II 12/23/2011 FERMENTA BIOTECH LTD CHOLECALCIFEROL USP (CRYSTALLINE VITAMIN D3) (ESUB) AS MANUFACTURED IN
HIMACHAL PRADESH, INDIA
25585 A III 12/13/2011 GUJARAT FOILS LTD BLISTER FOIL (BARE / COATED / PRINTED ALUMINIUM FOIL) AS MANUFACTURED IN
GUJARAT, INDIA
25586 A III 12/7/2011 AMPACET CORP 474974 GREEN PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA,
CARTERSVILLE, GA, HEATH, OH
25587 A II 12/13/2011 HETERO DRUGS LTD ACYCLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25588 A II 3/20/2012 EMCURE PHARMACEUTICALS LTD PROPAFENONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
25589 I II 12/21/2011 POLYPEPTIDE LABORATORIES SWEDEN AB TERLIPRESSIN ACETATE AS MANUFACTURED IN LIMHAMN, SWEDEN
25590 A II 1/30/2012 API INC PROCARBAZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ
25591 A III 3/20/2012 SHRIJI POLYMERS INDIA PVT LTD LIQUID MEDICATION DISPENSERS (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA FOR SHRIJI POLYMERS INDIA LTD
25592 A II 12/19/2011 ZHEJIANG CHENG YI PHARMACEUTICAL CO
LTD
CAPECITABINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
25593 A II 12/19/2011 FARMABIOS S P A METHYLTESTOSTERONE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV),
ITALY
Page 766
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25594 A II 1/19/2012 SUN PHARMACEUTICAL INDUSTRIES LTD DOXERCALCIFEROL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25595 A II 6/6/2012 K+S KALI GMBH POTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP AS MANUFACTURED IN DEUTSCHLAND,
GERMANY
25596 A III 11/22/2011 INDIAN EXTRUSIONS POLYPROPYLENE (PP) AND PET BOTTLES WITH CAPS AS MANUFACTURED IN DAMAN,
INDIA
25597 A IV 12/13/2011 CABOT SANMAR LTD CAB-O-SIL M-5P FUMED SILICA AS MANUFACTURED IN TAMIL NADU, INDIA
25598 A II 12/20/2011 HAYASHIBARA CO LTD MALTOSE MONOHYDRATE AS MANUFACTURED IN OKAYAMA, JAPAN
25599 A V 12/20/2011 HAUPT PHARMA WOLFRATSHAUSEN GMBH ASEPTIC PROCESS VALIDATION AS MANUFACTURED IN WOLFRATSHAUSEN, GERMANY
25600 A III 12/20/2011 FUJIMORI KOGYO CO LTD LAMINATED SHEET FOR USE IN OUTER PACKAGING OF DRUG PRODUCT AS
MANUFACTURED IN YOKOHAMA CITY, JAPAN
25601 A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M-TM#HET AS MANUFACTURED IN WALDKRAIBURG, GERMANY
25602 A III 12/21/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M - TM(3 TO 7)MHD AS MANUFACTURED IN WALDKRAIBURG, GERMANY
25603 A III 12/21/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M - TM(3 TO 4)RST AS MANUFACTURED IN WALDKRAIBURG, GERMANY
25604 A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M-TM # ADT AS MANUFACTURED IN WALDKRAIBURG, GERMANY
25605 A II 12/20/2011 WUXI JIDA PHARMACEUTICAL CO. LTD. RISPERIDONE AS MANUFACTURED IN JIANGYIN CITY, CHINA
25606 A II 12/13/2011 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
TESTOSTERONE PROPIONATE NON-STERILE BULK AS MANUFACTURED IN ZHEJIANG,
CHINA
25607 A III 12/21/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M - TM#LFT AS MANUFACTURED IN WALDKRAIBURG, GERMANY
25608 A II 12/22/2011 SMS PHARMACEUTICALS LTD RANITIDINE HYDROCHLORIDE USP (UNIT-VII) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
25609 A II 10/25/2011 JIANGXI FUSHINE PHARMACEUTICAL CO
LTD
SULBACTAM AS MANUFACTURED IN JINGDEZHEN CITY, CHINA
25610 A III 12/19/2011 EVONIK INDUSTRIES AG DEGALAN PM 555 AS MANUFACTURED IN DARMSTADT, GERMANY
25611 A III 12/19/2011 EVONIK INDUSTRIES AG DEGALAN VP 4164 E AS MANUFACTURED IN DARMSTADT, GERMANY
25612 A II 12/22/2011 MEDICHEM MANUFACTURING MALTA LTD MED-200400/M AS MANUFACTURED IN HAL FAR BBG, MALTA
25613 A II 2/12/2011 VITAL LABORATORIES PVT LTD SCOPOLAMINE HYDRO BROMIDE AS MANUFACTURED IN GUJARAT, INDIA
25614 A II 12/21/2011 HETERO DRUGS LTD FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25615 A II 12/20/2011 FARMABIOS S P A BUDESONIDE MICRONIZED STERILE AS MANUFACTURED IN GROPELLO CAIROLI (PV),
ITALY
25616 A III 12/13/2011 AMPACET CORP 100671 PP UV MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25617 A II 12/19/2011 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
EMTRICITABINE AS MANUFACTURED IN SHANGHAI, CHINA
25618 A II 12/22/2011 NEULAND LABORATORIES LTD PEMETREXED DISODIUM (FORM IV) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
FOR NEULAND LABORATORIES LTD
25619 A II 12/16/2011 SOCIETE INDUSTRIELLE DES OLEAGINEUX BXR US REFINED SOYBEAN OIL AS MANUFACTURED IN CEDEX, FRANCE
25620 A II 12/16/2011 SOCIETE INDUSTRIELLE DES OLEAGINEUX BXR US REFINED OLIVE OIL AS MANUFACTURED IN CEDEX, FRANCE
25621 A II 12/22/2011 TEVA PHARMACEUTICAL INDUSTRIES LTD OMEPRAZOLE AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
25622 A II 12/23/2011 EUTICALS SPA ROCURONIUM BROMIDE AS MANUFACTURED IN ROZZANO (MI), ITALY
25623 A II 12/23/2011 INKE SA RIZATRIPTAN BENZOATE AS MANUFACTURED IN BARCELONA, SPAIN
25624 A II 12/27/2011 MAC CHEM PRODUCTS INDIA PVT LTD DACARBAZINE USP AS MANUFACTURED IN DISTRICT THANE, INDIA
25625 I II 12/23/2011 JIANGSU HANSOH PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA
Page 767
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25626 I II 12/23/2011 JIANGSU HENGRUI MEDICINE CO LTD AZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS
MANUFACTURED IN JIANGSU, CHINA
25627 A III 12/12/2011 THURINGER PHARMAGLAS GMBH AND CO
KG
VIALS AND AMPOULES MADE OF TUBULAR GLASS AS MANUFACTURED IN
NEUHAUS/RENNWEG, GERMANY
25628 A II 12/22/2011 SIEGFRIED USA LLC OXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY) AS MANUFACTURED IN
PENNSVILLE, NEW JERSEY
25629 A II 12/23/2011 CRYSTAL PHARMA SAU BUDESONIDE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN
25630 A II 12/27/2011 EVERLIGHT CHEMICAL INDUSTRIAL CORP RASAGILINE MESYLATE AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN
25631 A II 12/5/2011 HUNAN YUANTONG PHARMACEUTICAL CO
LTD
DIOSMIN AS MANUFACTURED IN HUNAN PROVINCE, CHINA
25632 A II 12/13/2011 VITAL LABORATORIES PVT LTD YOHIMBINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA
25633 A II 2/15/2012 APICORE LLC CLOFARABINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25634 A II 12/27/2011 SCINOPHARM TAIWAN LTD BIVALIRUDIN AS MANUFACTURED IN TAINAN, TAIWAN
25635 A III 11/20/2011 VIVEK POLYMER (INDIA) PLASTIC BOTTLES AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA
25636 A II 12/28/2011 RAKS PHARMA PVT LTD CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25637 A II 12/29/2011 HETERO DRUGS LTD FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25638 A II 12/29/2011 PHARMACEUTICAL WORKS POLPHARMA SA IBANDRONATE SODIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
25639 A II 12/29/2011 MYLAN LABORATORIES LTD SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25640 A II 12/27/2011 SUZHOU LIXIN PHARMACEUTICAL CO LTD PEMETREXED DISODIUM AS MANUFACTURED IN JIANGSU, CHINA
25641 I II 12/28/2011 QILU PHARMACEUTICAL CO LTD ADEFOVIR DIPIVOXIL (NON STERILE, API) AS MANUFACTURED IN SHANDONG, CHINA
25642 A II 12/28/2011 MEGAFINE PHARMA P LTD PALIPERIDONE (NON- STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK, INDIA
25643 A III 1/3/2012 HUHTAMAKI FLEXIBLE PACKAGING
GERMANY GMBH & CO KG
FILM WRAPPER FOR TRANSDERMAL PATCHES AS MANUFACTURED IN RONSBERG,
GERMANY
25644 A II 1/29/2011 CHEMWERTH INC MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
FREIBURG, GERMANY FOR CHEMWERTH INC
25645 A IV 12/27/2011 IDEAL CURES PVT LTD ECOPAL TM RANGE OF ACRYLIC POLYMERS AS MANUFACTURED IN GUJARAT, INDIA
25646 A II 2/16/2012 CADILA HEALTHCARE LTD SALMETEROL XINAFOATE US(ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25647 A II 2/21/2012 CADILA HEALTHCARE LTD ETHACRYNIC ACID USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25648 A II 12/30/2011 RAKS PHARMA PVT LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25649 A II 1/16/2012 RANBAXY LABORATORIES LTD FOSAMPRENAVIR CALCIUM (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
25650 A II 1/10/2012 AUROBINDO PHARMA LTD RALOXIFENE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
25651 A II 12/30/2011 MYLAN LABORATORIES LTD PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25652 A II 12/30/2011 MYLAN LABORATORIES LTD DESMOPRESSIN ACETATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25653 A II 12/30/2011 MYLAN LABORATORIES LTD EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25654 A II 1/3/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD LOSARTAN POTASSIUM AS MANUFACTURED IN GAJRAULA, MALANPUR IN INDIA FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
25655 A III 12/30/2011 INTERNATIONAL CONVERTER LLC FLEXIBLE PACKAGING FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN
CALDWELL, OH AND LUKA, MS
25656 A II 1/13/2012 WOCKHARDT LTD DESVENLAFAXINE SUCCINATE MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT,
INDIA
25657 A II 2/20/2012 SUN PHARMACEUTICAL INDUSTRIES LTD ATORVASTATIN CALCIUM (AMORPHOUS) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
Page 768
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25658 P *** PENDING FILING REVIEW ***
25659 A II 12/30/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MITOMYCIN ALTERNATIVE PROCESS AS MANUFACTURED IN TAIZHOU, ZHEJIANG, CHINA
25660 I II 3/23/2012 IPCA LABORATORIES LTD ESCITALOPRAM OXALATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
25661 P *** PENDING FILING REVIEW ***
25662 A II 3/27/2012 IPCA LABORATORIES LTD TRIMETHOPRIM USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
25663 A II 1/3/2012 TORRENT PHARMACEUTICALS LTD REPAGLINIDE AS MANUFACTURED IN GUJARAT, INDIA
25664 A II 12/10/2010 ALP PHARM BEIJING CO LTD FEBUXOSTAT AS MANUFACTURED IN HUBEI, CHINA FOR ALP PHARM BEIJING CO LTD
25665 A II 12/30/2011 SCINOPHARM TAIWAN LTD BORTEZOMIB AS MANUFACTURED IN TAINAN, TAIWAN
25666 A II 12/22/2011 ALP PHARM BEIJING CO LTD CILOSTAZOL USP AS MANUFACTURED IN CHONGQING, CHINA FOR ALP PHARM BEIJING
CO LTD
25667 A II 2/2/2012 CHEMWERTH INC BUSULFAN USP NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN SICHUAN
PROVINCE, P. R. OF CHINA FOR CHEMWERTH INC
25668 P *** PENDING FILING REVIEW ***
25669 A II 2/16/2012 UNIMARK REMEDIES LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25670 A II 1/17/2012 SRI KRISHNA PHARMACEUTICALS LTD BUTORPHANOL TARTRATE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25671 A III 12/28/2011 H AND H GLASS INC AMBER AND FLINT GLASS AS MANUFACTURED IN HSINCHU, TAIWAN FOR H & H GLASS
INC
25672 A II 1/4/2012 SAMYANG GENEXBIO CORP DOCETAXEL ANHYDROUS AS MANUFACTURED IN DAEJEON, KOREA
25673 A II 4/10/2012 LUNDBECK PHARMACEUTICALS ITALY SPA ETHOTOIN (ESUB) AS MANUFACTURED IN PADOVA, ITALY FOR LUNDBECK LLC
25674 P *** PENDING FILING REVIEW ***
25675 A IV 12/30/2011 ILE PHARMACEUTICAL MATERIALS CO LTD ENTERIC FILM COATING SYSTEMS AS MANUFACTURED IN TIANJIN, CHINA
25676 A II 1/4/2012 AMINO CHEMICALS LTD RUFINAMIDE USP AS MANUFACTURED IN MARSA, MALTA
25677 A II 1/4/2012 AMINO CHEMICALS LTD DICLOFENAC EPOLAMINE AS MANUFACTURED IN MARSA, MALTA
25678 A II 1/4/2012 SAMYANG GENEXBIO CORP DOCETAXEL TRIHYDRATE AS MANUFACTURED IN SEOL, KOREA
25679 A II 1/5/2012 DAEWOONG BIO INC STERILE MEROPENEM AS MANUFACTURED IN KYUNGGI-DO, KOREA
25680 A II 1/5/2012 DAEWOONG BIO INC IOPROMIDE AS MANUFACTURED IN KYUNGGI-DO, KOREA
25681 A II 1/3/2012 JARI PHARMACEUTICAL CO LTD OXALIPLATIN AS MANUFACTURED IN JIANGSU, CHINA
25682 A II 1/6/2012 MSN LABORATORIES LTD FOSAPREPITANT DIMEGLUMINE [ROUTE CODE: "FD"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25683 A II 12/22/2011 ICROM SPA RISPERIDONE AS MANUFACTURED IN CONCOREZZO, ITALY
25684 A V 1/6/2012 DURECT CORP SUCROSE ACETATE ISOBUTYRATE (SAIB) AS MANUFACTURED IN VACAVILLE, CA
25685 A II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA
25686 A II 1/9/2012 HETERO LABS LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25687 A II 1/2/2012 POLYDRUG LABORATORIES PVT LTD CARISOPRODOL AS MANUFACTURED IN MAHARASHTRA, INDIA
25688 A III 1/6/2012 OREM ACCESS BIO INC MOISTURE AND ODOUR REGULATING PRODUCTS AS MANUFACTURED IN HYDERABAD,
ANDHRA PRADESH, INDIA
25689 A III 12/20/2011 SIBO G DOO CLOSURES SIBO AS MANUFACTURED IN SLOVENIA, EUROPE
25690 A IV 1/9/2012 FONA INTERNATIONAL INC PRODUCT # 889.0069U PEACH FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
25691 A IV 1/10/2012 LIPOID GMBH LIPOID PE 16:0/16:0-PEG 5000 (MPEG 5000-DPPE) AS MANUFACTURED IN
LUDWIGSHAFEN, GERMANY Page 769
4Q2012 2Q2014EXCEL
25692 A III 1/3/2012 ADHESIVES RESEARCH INC MA-69 (R-9667) AS MANUFACTURED IN GLEN ROCK, PA
25693 A II 1/4/2012 AVRA LABORATORIES PRIVATE LTD IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25694 A II 1/18/2012 AUROBINDO PHARMA LTD TADALAFIL (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25695 A II 5/15/2012 ENALTEC LABS PRIVATE LTD DALFAMPRIDINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25696 I II 3/20/2012 USV LIMITED COLESEVELAM HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25697 A II 12/30/2011 SHANDONG KEXING BIOPRODUCTS CO LTD RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR AS
MANUFACTURED IN ZHANG QIU-SHANDONG, CHINA
25698 A II 12/30/2011 SHANDONG KEXING BIOPRODUCTS CO LTD RECOMBINANT HUMAN ERYTHROPOIETIN AS MANUFACTURED IN ZHANG QIU-
SHANDONG, CHINA
25699 A IV 1/10/2012 CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE TM K2390.X01 AS MANUFACTURED
IN ALBERTA, CANADA
25700 A II 1/9/2012 FORMOSA LABORATORIES INC LINEZOLID AS MANUFACTURED IN TAOYUAN, TAIWAN
25701 A II 1/9/2012 FORMOSA LABORATORIES INC ULIPRISTAL ACETATE AS MANUFACTURED IN TAOYUAN, TAIWAN
25702 A III 1/9/2012 GREINER PACKAGING GMBH 250ML AND 950 ML PLASTIC BOTTLE INTENDED FOR PACKAGING ORAL SOLID DOSAGE
FORMS AS MANUFACTURED IN WERNBERG, AUSTRIA. RASTATT, GERMANY
25703 A II 4/9/2012 BIOCON LTD TRAVOPROST USP DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
25704 A IV 10/22/2011 FONA INTERNATIONAL INC 856.061 GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL
25705 A II 1/9/2012 QILU ANTIBIOTICS LINYI PHARMACEUTICAL
CO LTD
TERBINAFINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG
PROVINCE, P. R. OF CHINA
25706 A II 12/29/2011 KYONGBO PHARMACEUTICAL CO LTD MEROPENEM STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REP OF
KOREA
25707 A II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
VORICONAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA
25708 A IV 1/16/2012 CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE K2389.X01 AS MANUFACTURED IN
ALBERTA, CANADA
25709 A II 1/9/2012 SHANGHAI ZHONGXI SUNVE
PHARMACEUTICAL CO LTD
HYDROXYCHLOROQUINE SULFATE (USP) AS MANUFACTURED IN SHANGHAI, P. R. CHINA
25710 A II 12/29/2011 KYONGBO PHARMACEUTICAL CO LTD CEFTAZIDIME STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO,
REPUBLIC OF KOREA
25711 A II 2/18/2012 MACLEODS PHARMACEUTICALS LTD RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25712 A II 1/18/2012 HETERO DRUGS LTD OMEPRAZOLE, USP (FORM B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25713 A II 1/5/2012 MSN ORGANICS PVT LTD TOPIRAMATE USP [ROUTE CODE - "TI"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25714 A II 1/16/2012 SHANDONG NEW TIME PHARMACEUTICAL
CO LTD
POTASSIUM CLAVULANATE, DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1 AS
MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA
25715 A II 1/17/2012 VIWIT PHARMACEUTICAL CO LTD APREPITANT (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN TENGZHOU,
CHINA
25716 A II 1/14/2012 QILU ANTIBIOTICS PHARMACEUTICAL CO
LTD
STERILE CEFAZOLIN SODIUM PROCESS 1 AS MANUFACTURED IN JINAN CITY, CHINA
25717 A II 2/23/2012 COSMA SPA MILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN CISERANO(BERGAMO),
ITALY
25718 A II 1/16/2012 SHANDONG NEW TIME PHARMACEUTICAL
CO LTD
CLAVULANATE POTASSIUM AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA
25719 A II 1/16/2012 SHANDONG NEW TIME PHARMACEUTICAL
CO LTD
POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE
RATIO 1:1 AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA Page 770
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25720 A II 1/19/2012 APOTEX PHARMACHEM INDIA PVT LTD CAPECITABINE USP AS MANUFACTURED IN BANGALORE, INDIA
25721 A II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
CARVEDILOL DIHYDROGEN PHOSPHATE HEMIHYDRATE USP AS MANUFACTURED IN
ZHEJIANG, CHINA
25722 A III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO LTD PP/A1/PVC/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN HANGZHOU, CHINA
25723 A III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO LTD PVC/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN HANGZHOU, CHINA
25724 A III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO LTD PVC/PE/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN HANGZHOU, CHINA
25725 A III 12/10/2011 GUJARAT FOILS LTD STRIP FOIL (BARE/COATED/LAMINATED/PRINTED/ALUMINUM FOIL) AS MANUFACTURED
IN GUJARAT, INDIA
25726 A II 1/25/2012 CHENG FONG CHEMICAL CO LTD 4-PHENYLBUTYRIC ACID SODIUM SALT AS MANUFACTURED IN TAOYUAN COUNTY,
TAIWAN
25727 A II 3/26/2012 LUPIN LTD DESVENLAFAXINE BENZOATE(ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25728 A II 1/19/2011 BIOCON LTD HYDROXY ECHINOCANDIN AS MANUFACTURED IN BANGALORE, INDIA
25729 A IV 1/23/2012 FONA INTERNATIONAL INC 825.527 N-C CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL
25730 A II 1/24/2012 MSN LABORATORIES LTD BICALUTAMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25731 A II 1/25/2012 NS PHARMA INC NS-018 ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN YOKKAICHI, MIE, JAPAN FOR
NS PHARMA INC
25732 A III 1/19/2012 ADVANCED SCIENTIFICS INC POLYETHLENE BAGS AND TRANSFER TUBE ASSEMBLIES AS MANUFACTURED IN
MILLERSBURG, PA
25733 A II 1/26/2012 NEULAND LABORATORIES LTD DEFERASIROX AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25734 A II 3/8/2012 DR REDDYS LABORATORIES LTD ZOLMITRIPTAN (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25735 A II 1/26/2012 BACHEM SA ZIPRASIDONE HCL H2O AS MANUFACTURED IN VIONNAZ, SWITZERLAND
25736 A II 1/24/2012 BCN PEPTIDES VASOPRESSIN AS MANUFACTURED IN BARCELONA, SPAIN
25737 I II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG, CHINA
25738 A II 2/7/2012 WISDOM PHARMCEUTICAL CO LTD BENAZEPRIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
25739 A IV 1/10/2012 TAKASAGO INTERNATIONAL CORP DORANGE FLAVOR OT-42107 AS MANUFACTURED IN IBARAKI, JAPAN
25740 A II 1/26/2012 POLYMED THERAPEUTICS INC BORTEZOMIB DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA FOR
POLYMED THERAPEUTICS INC
25741 A IV 1/28/2012 TOAGOSEI CO LTD POLYACRYLATE POLYMERS- ARONVIS AH-105, AH-105X, AH-106X, MX, SX, AND JURYMER
AC-10H AS MANUFACTURED IN KAGAWA, JAPAN
25742 A II 1/25/2012 SIGNA SA DE CV TELMISARTAN USP/EP AS MANUFACTURED IN TOLUCA ESTADO DE MEXICO, MEXICO
25743 A II 6/18/2012 JUHUA GROUP CORP PHARMACEUTICAL
FACTORY
DIFLUNISAL USP (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25744 A II 2/23/2012 EMCURE PHARMACEUTICALS LTD MYCOPHENOLATE MOFETIL USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25745 A II 3/26/2012 DR REDDYS LABORATORIES LTD ASENAPINE MALEATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25746 A II 1/31/2012 APOTEX PHARMACHEM INDIA PVT LTD MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN BANGALORE, INDIA
25747 A II 1/30/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD DESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX AS MANUFACTURED IN
PRIGORJE BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
25748 A II 1/30/2012 BLUE ZONE TECHNOLOGIES LTD DESFLURANE USP AS MANUFACTURED IN ONTARIO, CANADA
25749 A II 1/30/2012 TEVA PHARMACEUTICALS INDUSTRIES LTD DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL AND
PRIGORJE BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
25750 A II 3/20/2012 EMCURE PHARMACEUTICALS LTD NISOLDIPINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
Page 771
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25751 A II 2/24/2012 LUPIN LTD DESVENLAFAXINE SUCCINATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25752 A II 2/10/2012 PAN DRUGS LTD GUAIFENESIN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25753 A II 4/2/2012 LUPIN LTD RALTEGRAVIR POTASSIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25754 A IV 2/3/2012 FONA INTERNATIONAL INC 856.485 N-C GRAPE FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
25755 A IV 1/10/2012 JUKU ORCHEM PRIVATE LTD MICROCRYSTALLINE CELLULOSE USP AS MANUFACTURED IN TAMILNADU, INDIA
25756 A III 2/1/2012 DA PRO RUBBER INC DPXB433-5 AS MANUFACTURED IN BROKEN ARROW, OK
25757 A III 2/27/2012 SANNER GMBH DESICCANT CARTRIDGES AS MANUFACTURED IN BENSHEIM, GERMANY; KUNSHAN,
CHINA; BUDAPEST, HUNGARY FOR SANNER GMBH
25758 A II 2/3/2012 PFANSTIEHL INC PODOPHYLLOTOXIN (P-126) AS MANUFACTURED IN WAUKEGAN, IL
25759 A II 1/18/2012 JIANGSU YEW PHARMACEUTICAL CO LTD PACLITAXEL AS MANUFACTURED IN JIANGSU, CHINA
25760 A II 2/3/2012 LIFECORE BIOMEDICAL LLC SODIUM HYALURONATE POWDER, SPECIFICATION LPD-9800037, PH 4.0 PROCESS AS
MANUFACTURED IN CHASKA, MN
25761 A II 2/24/2012 UNIMARK REMEDIES LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25762 A II 2/8/2012 AMOLI ORGANICS PVT LTD LEVETIRACETAM USP [ROUTE CODE - LVS] (ESUB) AS MANUFACTURED IN GUJARAT
STATE, INDIA
25763 A II 3/19/2012 EMCURE PHARMACEUTICALS LTD IBUTILIDE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25764 A II 3/20/2012 EMCURE PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25765 A II 3/19/2012 EMCURE PHARMACEUTICALS LTD ARGATROBAN MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25766 A II 7/25/2012 MALLINCKRODT INC HYDROMORPHONE HYDROCHLORIDE USP (NP), MALLINCKRODT INC. CODE 3222 (ESUB)
AS MANUFACTURED IN ST. LOUIS, MISSOURI
25767 N NOT AN ASSIGNED NUMBER
25768 A II 3/1/2012 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
RISEDRONATE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25769 A II 2/7/2012 POLYMED THERAPEUTICS INC CABAZITAXEL MONOHYDRATE AS MANUFACTURED IN CHONGQING, CHINA FOR
POLYMED THERAPEUTICS INC
25770 A II 2/9/2012 HETERO LABS LTD QUETIAPINE FUMARATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25771 I II 6/29/2012 THE PROCTER AND GAMBLE CO ALIGN PRODUCT CONTAINING BIFANTIS (BIFIDOBACTERIUM LONGUM SUBSP. INFANTIS
36524) (ESUB) AS MANUFACTURED IN HOLLAND, MI FOR THE PROCTER & GAMBLE
COMPANY
25772 P *** PENDING FILING REVIEW ***
25773 A II 3/29/2012 GLENMARK GENERICS LTD SITAGLIPTIN PHOSPHATE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
25774 A III 2/7/2012 PROMENS HF POLYETHYLENE VIALS AS MANUFACTURED IN LANGESKOV, DENMARK FOR PROMENS
HR.
25775 A II 12/30/2011 WATERSTONE PHARMACEUTICALS HUBEI
TIANMEN CO LTD
LAMOTRIGINE AS MANUFACTURED IN HUBEI TIANMEN PROVINCE, CHINA
25776 A II 9/30/2013 MALLINCKRODT INC METHYLPHENIDATE HYDROCHLORIDE USP (NP) (ESUB) AS MANUFACTURED IN ST.
LOUIS, MO
25777 A II 2/13/2012 APOTEX PHARMACHEM INC DESVENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN BRANTFORD
ONTARIO, CANADA
25778 A II 2/27/2012 ALEMBIC PHARMACEUTICALS LTD API DIV FLUOXETINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25779 A II 2/14/2012 INOGENT LABORATORIES PRIVATE LTD LAMOTRINGINE AS MANUFACTURED IN HYDERABAD, INDIA
25780 A III 2/10/2012 CHARTER NEX FILMS INC NEX 1509 SINGLE-LAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN
TURNERS FALLS, MA
25781 A II 2/10/2012 ZHEJIANG NEO DANKONG
PHARMACEUTICAL CO LTD
ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES AS MANUFACTURED
IN TAIZHOU, CHINA
Page 772
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25782 A III 1/31/2012 AMCOR FLEXIBLES GENT EXTRUDED FILMS AND LAMINATES FOR PACKAGING AS MANUFACTURED IN GENT,
BELGIUM
25783 A II 2/13/2012 GUANGZHOU HANFANG PHARMACEUTICAL
CO LTD
VINORELBINE TARTRATE, USP AS MANUFACTURED IN GUANGDONG, CHINA
25784 A II 2/15/2012 AVANTI POLAR LIPIDS INC (5Z,8Z, 11Z)-N-CYCLOPROPYL-14-(N-ISOPROPYL-HEXANAMIDO) TETRADECA-5,8,11-
TRIENAMIDE (CMX-20) AS MANUFACTURED IN ALABASTER, ALABAMA
25785 A II 1/30/2012 MICRO LABS LTD INDIA MELOXICAM USP AS MANUFACTURED IN KARNATAKA, INDIA
25786 A IV 2/14/2012 FMC CORP FMC BIOPOLYMER DIV AVICEL(R) DG BINDER - MICROCRYSTALLINE CELLULOSE AND ANHYDROUS DICALCIUM
PHOSPHATE AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA FOR FMC CORP( FMC
BIOPOLYMER DIV)
25787 A II 3/27/2012 LUPIN LTD TENOFOVIR DISOPROXIL FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
25788 P *** PENDING FILING REVIEW ***
25789 A II 3/1/2013 CHEMSPEC API CALCIUM LEVOMEFOLATE (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ
25790 A II 1/19/2012 MEITEK TECHNOLOGY QINGDAO CO LTD CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
25791 A II 2/14/2012 FARMABIOS S P A MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY
25792 A II 6/29/2012 MACLEODS PHARMACEUTICALS LTD CELECOXIB (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25793 A II 4/9/2012 MACLEODS PHARMACEUTICALS LTD IBANDRONATE SODIUM MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25794 A II 3/14/2012 MACLEODS PHARMACEUTICALS LTD LANSOPRAZOLE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25795 A II 4/9/2012 MACLEODS PHARMACEUTICALS LTD VARDENAFIL HYDROCHLORIDE TRIHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT,
INDIA
25796 A II 2/17/2012 CRYSTAL PHARMA SAU DROSPIRENONE NON MICRONIZED AND MICRONIZED AS MANUFACTURED IN BOECILLO
(VALLADOLID), SPAIN
25797 A II 2/17/2012 CHROMO LABORATORIES INDIA PRIVATE
LTD
CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25798 A II 2/16/2012 SYMBIOTEC PHARMALAB LTD BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN MADHYA PRADESH, INDIA
25799 A III 2/17/2012 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEM 'SQUEEZE NASAL SPRAY/NEBULIZER SYSTEM'
AS MANUFACTURED IN BANGALORE, INDIA
25800 A II 2/21/2012 HETERO LABS LTD BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25801 A II 2/22/2012 HEINKE TECHNOLOGY INC PRE-FILLED VAGINAL APPLICATOR WITH SIDE DISPERSION TIP AS MANUFACTURED IN
LINCOLN, NE
25802 A III 2/8/2012 AVANTIS PACKAGING INC PLASTIC BOTTLES & CONTAINERS AS MANUFACTURED IN QUEBEC, CANADA
25803 A II 2/10/2012 SYMRISE AG 210363 NATURAL & ARTIFICIAL FLAVOR LEMON TYPE AS MANUFACTURED IN
HOLZMINDEN, GERMANY
25804 I II 3/27/2012 EMCURE PHARMACEUTICALS LTD DOCETAXEL USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25805 A II 3/26/2012 EMCURE PHARMACEUTICALS LTD ZILEUTON USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25806 A II 3/27/2012 EMCURE PHARMACEUTICALS LTD PROMETHAZINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
25807 A II 3/31/2012 EMCURE PHARMACEUTICALS LTD BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25808 A II 3/27/2012 EMCURE PHARMACEUTICALS LTD ETODOLAC USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25809 A II 3/30/2012 EMCURE PHARMACEUTICALS LTD ACAMPROSATE CALCIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
Page 773
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25810 A II 3/14/2012 AUROBINDO PHARMA LTD TELMISARTAN USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
25811 A II 12/22/2011 JOHNSON MATTHEY INC PHARMACEUTICAL
MATERIALS GROUP
JOHNSON MATTHEY 1319 AS MANUFACTURED IN WEST DEPTFORD, NJ
25812 A IV 2/15/2012 ABELEI INC 164A50 NATURAL LEMON LIME FLAVOR WONF POWDER AS MANUFACTURED IN NORTH
AURORA, IL
25813 A III 2/17/2012 PROMENS HF CYCLOOLEFIN VIALS AS MANUFACTURED IN LANGESKOV, DENMARK FOR PROMENS HF.
25814 A II 2/22/2012 CATALENT PHARMA SOLUTIONS LLC MDV3100, 40MG, CAPSULES (SOFTGELS) AS MANUFACTURED IN ST. PETERSBURG, FL
25815 A II 2/22/2012 APOTEX PHARMACHEM INDIA PVT LTD TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA AND BRANTFORD ONTARIO,
CANADA FOR APOTEX PHARMACHEM INC.
25816 A II 4/2/2012 LUPIN LTD ESTRADIOL HEMIHYDRATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
25817 A II 2/22/2012 NEULAND LABORATORIES LTD BRINZOLAMIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25818 I II 2/20/2012 APOTEX PHARMACHEM INDIA PVT LTD LEVOTHYROXINE SODIUM USP AS MANUFACTURED IN BANGALORE, INDIA
25819 A III 4/5/2012 NAGL MANUFACTURING CO FLO-THRU APPLICATOR (ESUB) AS MANUFACTURED IN OMAHA, NE
25820 A II 4/2/2012 LUPIN LTD AZITHROMYCIN MONOHYDRATE USP (PROCESS B) (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
25821 A II 2/23/2012 NINGBO RENJIAN PHARMACEUTICAL GROUP
CO LTD
HUMAN CHORIONIC GONADOTROPIN USP AS MANUFACTURED IN ZHEJIANG PROVINCE,
CHINA
25822 A II 2/23/2012 FUJIAN SOUTH PHARMACEUTICAL CO LTD PACLITAXEL (SEMI-SYNTHETIC) USP NON STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA
25823 A II 10/12/2011 MELODY HEALTHCARE PVT LTD MONTELUKAST SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA
25824 A IV 2/24/2012 FONA INTERNATIONAL INC 826.595 CHOCOLATE EXTRACT, NAT AS MANUFACTURED IN GENEVA, IL
25825 A II 2/22/2012 JIANGXI SYNERGY PHARMACEUTICAL CO
LTD
GABAPENTIN[H] AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA
25826 A II 2/24/2012 OLON SPA BENDAMUSTINE HCL AS MANUFACTURED IN RODANO (MI), ITALY
25827 A II 2/22/2012 SWATI SPENTOSE PVT LTD PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
25828 A II 3/24/2012 CTX LIFE SCIENCES PVT LTD ALENDRONATE SODIUM USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25829 A II 3/24/2012 CTX LIFE SCIENCES PVT LTD TERAZOSIN HYDROCHLORIDE DIHYDRATE USP (ESUB) AS MANUFACTURED IN GUJARAT,
INDIA
25830 A II 2/22/2012 SWATI SPENTOSE PVT LTD LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA
25831 A II 2/24/2012 ST GOBAIN PERFORMANCE PLASTICS CORP TYGON? 2475 HIGH PURITY TUBING AND TYGON? 2475 I.B. HIGH PURITY PRESSURE
TUBING AS MANUFACTURED IN AKRON, OHIO
25832 A IV 2/28/2012 FONA INTERNATIONAL INC 800.119 TOASTED ALMOND FLAVOR EMULSION, NAT WONF AS MANUFACTURED IN
GENEVA, IL
25833 A IV 2/28/2012 FONA INTERNATIONAL INC 816.0530U BUTTER TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL
25834 A III 2/21/2012 AMPACET CORP 110730 WHITE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25835 A II 2/17/2012 SUNBIO INC METHOXY POLYETHYLENE GLYCOL PROPIONALDEHYDE 20,000 AS MANUFACTURED IN
ANYANG CITY, S. KOREA
25836 A IV 4/1/2012 EMCURE PHARMACEUTICALS LTD PREMIX FOR BUSULFAN (WITHOUT ACTIVE) (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
25837 A II 2/21/2012 MSN LABORATORIES LTD DEFERASIROX [ROUTE CODE - "DR"] [NON-STERILE DRUG SUBSTANCE] AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
25838 A IV 2/29/2012 ASAHI KASEI CHEMICALS CORP PREGELATINIZED STARCH (USP / NF) AS MANUFACTURED IN NARA, JAPAN FOR ASAHI
KASEI CHEMICALS CORPORATION
Page 774
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25839 A III 3/2/2012 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEM 'TR' DESIGN AS MANUFACTURED IN
BANGALORE, INDIA
25840 A II 11/22/2011 NANDU CHEMICAL INDUSTRIES 'POTASSIUM CHLORIDE BP' AS MANUFACTURED IN KARNATAKA, INDIA
25841 A II 11/22/2011 NANDU CHEMICAL INDUSTRIES 'MAGNESIUM CHLORIDE HEXAHYDRATE BP' AS MANUFACTURED IN KARNATAKA, INDIA
25842 A III 3/1/2012 POLYONE CORP CC10132453WE (WHITE PEARL PP/PE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
25843 A II 3/6/2012 MAC CHEM PRODUCTS INDIA PVT LTD PACLITAXEL USP AS MANUFACTURED IN DISTRICT THANE, INDIA
25844 A II 2/29/2012 ZHUHAI UNITED LABORATORIES CO LTD CEFOTAXIME SODIUM USP AS MANUFACTURED IN GUANGDONG, P. R. CHINA
25845 A II 2/27/2012 AREVIPHARMA GMBH TORASEMIDE AS MANUFACTURED IN RADEBEUL, GERMANY
25846 A II 3/2/2012 PROACTA INC SN35006 AS MANUFACTURED IN NORTH SYRACUSE, NY FOR PROACTA, INC.
25847 A II 3/2/2012 PROACTA INC SN33962 AS MANUFACTURED IN NORTH SYRACUSE, NY FOR PROACTA, INC
25848 A II 3/1/2012 SECOND PHARMA CO LTD VALSARTAN AS MANUFACTURED IN SHANGYU CITY, P. R. CHINA
25849 A II 3/13/2012 AMOLI ORGANICS PVT LTD HYDROCHLOROTHIAZIDE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
25850 A II 3/5/2012 SAVIOR LIFETEC CORP TAINAN BRANCH STERILE SODIUM BICARBONATE USP AS MANUFACTURED IN TAIWAN, REPUBLIC OF
CHINA
25851 A II 2/28/2012 ORCHEV PHARMA PVT LTD RANITIDINE HYDROCHLORIDE USP (POLYMORPH FORM - II) CRYSTALLINE POWDER
GRADE AND DC GRADE AS MANUFACTURED IN GUJARAT STATE, INDIA
25852 A III 3/8/2012 JIANGSU HUALAN NEW PHARMACEUTICAL
MATERIAL CO LTD
BUTYL RUBBER STOPPERS AS MANUFACTURED IN CHONGQING CITY, CHINA FOR
JIANGSU HUALAN NEW PHARMACEUTICAL MATERIAL CO., LTD
25853 A II 3/23/2012 3D IMAGING DRUG DESIGN AND
DEVELOPMENT LLC
SODIUM IODIDE I 124 (ESUB) AS MANUFACTURED IN LITTLE ROCK, ARKANSAS
25854 A II 3/30/2012 LUPIN LTD ESTRADIOL VALERATE USP(ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
25855 A II 3/24/2012 DR REDDYS LABORATORIES LTD GLATIRAMER ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25856 A II 3/30/2012 NORAMCO INC CODEINE PHOSPHATE (ESUB) AS MANUFACTURED IN ATHENS, GA AND WILMINGTON, DE
25857 A II 6/13/2012 PAR PHARMACEUTICAL INC TOLCAPONE, USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR
PHARMACEUTICAL INC
25858 A II 3/30/2012 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25859 P *** PENDING FILING REVIEW ***
25860 A II 3/7/2012 ULKAR KIMYA SANAYII VE TICARET AS OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN TEKIRDAG, TURKEY
25861 A II 3/7/2012 ULKAR KIMYA SANAYII VE TICARET AS IRBESARTAN USP AS MANUFACTURED IN TEKIRDAG, TURKEY
25862 A IV 3/9/2012 FONA INTERNATIONAL INC 906.0312U RASPBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
25863 I II 3/7/2012 OLON SPA ROTIGOTINE AS MANUFACTURED IN RODANO (MI), ITALY
25864 P *** PENDING FILING REVIEW ***
25865 A II 3/30/2012 DR REDDYS LABORATORIES LTD MILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
25866 A II 3/28/2012 SUN PHARMACEUTICAL INDUSTRIES LTD GANIRELIX ACETATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
25867 A II 3/2/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN MADHYA PRADESH, INDIA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD.
25868 A II 4/20/2012 IND SWIFT LABORATORIES LTD CLOPIDOGREL CAMPHOR SULFONATE (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
25869 A II 3/31/2012 UNIMARK REMEDIES LTD MEROPENEM TECHNICAL (ESUB) AS MANUFACTURED IN STATE-GUJARAT, INDIA
25870 A II 3/30/2012 ARCH PHARMALABS LTD PACLITAXEL USP (SEMI-SYNTHETIC) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
25871 A II 12/22/2011 ERREGIERRE SPA RIVASTIGMINE AS MANUFACTURED IN BERGAMO, ITALY
Page 775
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25872 A II 3/30/2012 DR REDDYS LABORATORIES LTD LENALIDOMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25873 A II 3/30/2012 DR REDDYS LABORATORIES LTD ESCITALOPRAM OXALATE (PROCESS II) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
25874 A II 3/12/2012 SIFAVITOR SRL RACEPINEPHRINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN FOR
SIFAVITOR S.R.L
25875 A II 3/16/2012 DSM SINOCHEM PHARMACEUTICALS
NETHERLANDS BV
AMOXICILLIN TRIHYDRATE (PURIMOX) AS MANUFACTURED IN PUNJAB, INDIA FOR DSM
SINOCHEM PHARMACEUTICALS NETHERLANDS B.V.
25876 A III 3/13/2012 SHAILY ENGINEERING PLASTICS LTD LOGENGES HANDLE AS MANUFACTURED IN STATE-GUJARAT, INDIA
25877 A II 3/2/2012 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
LANSOPRAZOLE AS MANUFACTURED IN SHOUGUANG CITY, CHINA
25878 A II 12/12/2011 ANYGEN CO LTD LEUPRORELIN ACETATE AS MANUFACTURED IN JEOLLANAM-DO, SOUTH KOREA
25879 A II 4/4/2012 LUPIN LTD LOSARTAN POTASSIUM USP (CRYSTALLINE) (ESUB) AS MANUFACTURED IN MUMBAI,
INDIA
25880 A II 3/30/2012 DR REDDYS LABORATORIES LTD BAZEDOXIFENE ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25881 A II 3/3/2012 MSN LABORATORIES PVT LTD TROSPIUM CHLORIDE [ROUTE CODE - ''TC''] AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
25882 A II 3/19/2012 COVALENT LABORATORIES PRIVATE LTD CEFDINIR USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25883 A II 3/16/2012 APTALIS PHARMA SRL PANCREATIC ENZYME PRODUCT (PEP) DELAYED RELEASE CAPSULES 750 U USPL AS
MANUFACTURED IN MILAN, ITALY
25884 A III 3/5/2012 ESS DEE ALUMINIUM LTD NON TOXIC FOOD/ PHARMA GRADE PLAIN AND PRINTED 3 PLY; 4 PLY LAMINATE AS
MANUFACTURED IN NANI DAMAN, INDIA
25885 A III 3/6/2012 BORMIOLI ROCCO SPA BU PLASTICS SYRINGE DOSING 0,5-5ML AS MANUFACTURED IN SAINT SULPICE, FRANCE;
CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV), ITALY
25886 A III 3/6/2012 BORMIOLI ROCCO SPA BU PLASTICS BOTTLE PET 130 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO
(PV), ITALY; SAINT SULPICE, FRANCE
25887 A II 4/2/2012 ALEMBIC PHARMACEUTICALS LTD API DIV SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25888 A II 3/30/2012 JUBILANT LIFE SCIENCES LTD DEFERASIROX (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA
25889 A II 3/29/2012 JUBILANT LIFE SCIENCES LTD CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25890 A II 3/29/2012 JUBILANT LIFE SCIENCES LTD DULOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25891 A II 3/12/2012 ZHUHAI UNITED LABORATORIES CO LTD MEROPENEM FOR INJECTION BULK STERILE AS MANUFACTURED IN GUANGDONG, P. R.
CHINA
25892 A II 4/9/2012 CTX LIFE SCIENCES PVT LTD AMIODARONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25893 A II 2/20/2012 ALP PHARM BEIJING CO LTD ARGATROBAN HYDRATE AS MANUFACTURED IN SUZHOU, CHINA FOR ALP PHARM
BEIJING CO., LTD
25894 A II 3/19/2012 FORMOSA LABORATORIES INC IXABEPILONE AS MANUFACTURED IN TAOYUAN, TAIWAN
25895 A II 3/19/2012 LABORATORIOS IMPERIALES SA DE CV BISMUTH SUBNITRATE AS MANUFACTURED IN MORELOS, MEXICO
25896 A III 3/13/2012 AMERICHEM INC 62838-F50 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH
25897 A II 3/31/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD ANASTROZOLE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
25898 A II 3/21/2012 ALEMBIC PHARMACEUTICALS LTD API DIV PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
25899 A II 3/2/2012 CSPC INNOVATION PHARM CO LTD PENTOXIFYLLINE AS MANUFACTURED IN SHIJIAZHUANG CITY, CHINA
25900 A III 2/29/2012 BOREALIS AG BORMED HE9601-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS
AG
25901 A II 4/2/2012 AUROBINDO PHARMA LTD CLINDAMYCIN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
Page 776
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25902 A II 3/23/2012 DR REDDYS LABORATORIES LTD ATORVASTATIN CALCIUM (BUTYLATED HYDROXY ANISOLE PREMIX) AS MANUFACTURED
IN ANDHRA PRADESH, INDIA
25903 A II 3/19/2012 LAURUS LABS PRIVATE LTD BIMATOPROST AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25904 A II 3/1/2012 QILU TIANHE PHARMACEUTICAL CO LTD PIPERACILLIN (NON-STERILE API) AS MANUFACTURED IN JINAN, CHINA
25905 A II 7/18/2012 SHILPA MEDICATE LTD ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25906 A II 6/19/2012 GLAXOSMITHKLINE LLC VILANTEROL TRIFENATATE (ESUB) AS MANUFACTURED IN JURONG, SINGAPORE;
HERTFORDSHIRE, UK FOR GLAXOSMITHKLINE LLC
25907 A II 3/30/2012 UNICHEM LABORATORIES LTD PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (ESUB) AS MANUFACTURED IN
DIST. RAIGAD, INDIA
25908 A II 4/2/2012 ALP PHARM BEIJING CO LTD ALVIMOPAN DIHYDRATE (ESUB) AS MANUFACTURED IN SUZHOU, CHINA FOR ALP PHARM
BEIJING CO LTD
25909 A II 4/18/2012 TRIS PHARMA INC METHYLPHENIDATE ERCT (METHYLPHENIDATE ER CHEWABLE TABLETS (CII)) (ESUB)
25910 A II 5/8/2012 DR REDDYS LABORATORIES LTD RIVASTIGMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25911 A III 2/10/2012 SIDDHI FOILS ALUMINIUM FOIL PLAIN AND PRINTED, LAMINATED AND HEAT SEAL LACQUER (HSL)
COATED FOR PHARMACEUTICAL TABLETS/ CAPSULES/ SOLID DOSAGE FORMS COLD
FORM ALU ALU FOIL PLAIN AND PRINTED AS MANUFACTURED IN UTTARAKHAND, INDIA
25912 A V 10/22/2012 GRAND RIVER ASEPTIC MANUFACTURING STERILE CONTRACT MANUFACTURING FACILITY (ESUB) AS MANUFACTURED IN GRAND
RAPIDS, MI
25913 A II 5/5/2012 NECTAR LIFESCIENCES LTD CEFEPIME FOR INJECTION USP (STERILE BULK) DRUG SUBSTANCE (ESUB) AS
MANUFACTURED DISTRICT MOHALI (PUNJAB), INDIA
25914 A II 3/27/2012 UQUIFA MEXICO SA DE CV ALBENDAZOLE AS MANUFACTURED IN MORELOS, MEXICO
25915 A II 4/2/2012 CADILA HEALTHCARE LTD BOSENTAN MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25916 A II 5/17/2012 CADILA HEALTHCARE LTD FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
25917 A III 3/22/2012 AMPACET CORP 432619 YELLOW PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25918 A II 3/28/2012 INDUSTRIALE CHIMICA SRL BRINZOLAMIDE, USP AS MANUFACTURED IN SARONNO (VARESE), ITALY AND
BUCHAREST, ROMANIA FOR INDUSTRIALE CHIMICA S. R. L.
25919 A III 3/22/2012 AMPACET CORP 454113 RED PP MP AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25920 A III 3/22/2012 AMPACET CORP 474268 GREEN PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25921 A III 3/22/2012 AMPACET CORP 463728 BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
25922 A III 3/21/2012 AMERICHEM INC 61918-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH
25923 A III 3/28/2012 SYMETAL ALUMINIUM FOIL INDUSTRY SA LACQUERED BLISTER FOIL 20 - 25 MICRONS ALLOY 1200 AS MANUFACTURED IN ATHENS,
GREECE
25924 A II 3/30/2012 IRIX MANUFACTURING INC LATANOPROST AS MANUFACTURED IN GREENVILLE, SC
25925 A II 3/27/2012 MEITEK TECHNOLOGY QINGDAO CO LTD CHONDROITIN SULFATE CALCIUM AS MANUFACTURED IN QINGDAO CITY
25926 A II 3/30/2012 AMRI RENSSELAER INC PENTOBARBITAL SODIUM, USP DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER,
NEW YORK
25927 P *** PENDING FILING REVIEW ***
25928 A II 3/5/2012 TOMITA PHARMACEUTICAL CO LTD N.F. CALCIUM SILICATE (AS FLORITE R) AS MANUFACTURED IN TOKUSHIMA, JAPAN
25929 A II 4/3/2012 AARTI DRUGS LTD DICLOFENAC EPOLAMINE AS MANUFACTURED IN MAHARASHTRA, INDIA
25930 A II 3/30/2012 SHARON BIO MEDICINE LTD MOXIFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
25931 A II 4/2/2012 INDUSTRIALE CHIMICA SRL LATANOPROST AS MANUFACTURED IN SARONNO (VARESE), ITALY
Page 777
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25932 A II 3/27/2012 ERREGIERRE SPA N-[4-(TRIFLUOROMETHYL)BENZYL]-4-METHOXYBUTYRAMIDE AS MANUFACTURED IN SAN
PAOLO D'ARGON (BERGAMO), ITALY
25933 A II 3/27/2012 FARMABIOS S P A BUSULFAN AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY
25934 A II 3/27/2012 SPLACK SA SILIPAC; CARBONPAC; MIXPAX; MOLPAC - DESICCANT BAGS AS MANUFACTURED IN
ATIBAIA, SP BRAZIL
25935 A II 5/19/2012 GLAND PHARMA LTD TIGECYCLINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25936 A II 5/29/2012 TOPCHEM PHARMACEUTICALS LTD ETHACRYNIC ACID (ESUB) AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND
25937 A II 4/20/2012 TOPCHEM PHARMACEUTICALS LTD BRETYLIUM TOSYLATE AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND
25938 A II 6/6/2012 GLAND CHEMICALS PRIVATE LTD GEMCITABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
25939 A II 4/2/2012 FARMAK AS REGADENOSON AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC
25940 A III 6/6/2012 SOOD PLASTICS PRIVATE LTD PLASTIC CLOSURES (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
25941 A III 5/25/2012 SOOD PLASTICS PRIVATE LTD PLASTIC BOTTLES (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
25942 A II 3/30/2012 NANOTHERAPEUTICS INC TRIAPINE DRUG SUBSTANCE AS MANUFACTURED IN LENEXA, KS FOR
NANOTHERAPEUTICS, INC
25943 A II 3/30/2012 NANOTHERAPEUTICS INC TRIAPINE INJECTION AS MANUFACTURED IN CHARLESTON , SC FOR
NANOTHERAPEUTICS, INC
25944 A II 4/3/2012 LIPOID GMBH LIPOID S 100 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY; KOLN, GERMANY FOR
LIPOID GMBH
25945 A III 3/16/2012 ZHENGZHOU AOXIANG PHARMACEUTICAL
PACKING CO LTD
HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION STERILE FREEZE-DRYING
POWDER (BROMOBUTYL) AS MANUFACTURED IN DENGFENG CITY, CHINA
25946 A II 2/29/2012 ZHUHAI UNITED LABORATORIES CO LTD CEFTRIAXONE SODIUM USP AS MANUFACTURED IN GUANGDONG, P. R. CHINA
25947 A II 5/17/2012 THERAPEUTIC PROTEINS INTERNATIONAL
LLC
COMPOUND FILGRASTIM (G-CSF) CONCENTRATED SOLUTION, EP (ESUB) AS
MANUFACTURED IN CHICAGO, IL
25948 A III 4/6/2012 RACER TECHNOLOGY PTE LTD OINTMENT APPLICATOR AS MANUFACTURED IN CHANGI SOUTH INDSTURIAL ESTATE,
SINGAPORE
25949 A III 3/16/2012 ZHENGZHOU AOXIANG PHARMACEUTICAL
PACKING CO LTD
HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION (BROMOBUTYL) AS
MANUFACTURED IN DENGFENG CITY, CHINA
25950 A III 3/16/2012 ZHENGZHOU AOXIANG PHARMACEUTICAL
PACKING CO LTD
HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION STERILE POWDER
(BROMOBUTYL) AS MANUFACTURED IN DENGFENG CITY, CHINA
25951 I II 3/30/2012 SYNKEM SAS QUETIAPINE FUMARATE AS MANUFACTURED IN CHENOVE, FRANCE
25952 A III 2/4/2012 RAVIRAJ FOILS LTD ALU-ALU (COLD FORMING BLISTER) LAMINATE' AS MANUFACTURED IN GUJARAT, INDIA
25953 A III 3/17/2012 ASAHI RUBBER INC RUBBER GASKET FOR DISPOSABLE SYRINGE AS MANUFACTURED IN FUKUSHIMA,
PREFECTURE, JAPAN
25954 A II 10/26/2011 FERMION OY QUETIAPINE FUMARATE "ALTERNATIVE PROCESS" AS MANUFACTURED IN HANKO,
FINLAND
25955 A II 3/29/2012 RAKS PHARMA PVT LTD DOXYCYCLINE HYCLATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25956 A II 4/11/2012 SHASUN PHARMACEUTICALS LTD PITAVASTATIN CALCIUM AS MANUFACTURED IN CUDDALORE, INDIA
25957 A II 4/10/2012 CF PHARMA LTD METHOTREXATE AS MANUFACTURED IN BUDAPEST, HUNGARY
25958 A II 3/1/2012 HUNAN YUXIN PHARMACEUTICAL CO LTD MOMETASONE FUROATE AS MANUFACTURED IN SHAOYANG CITY, CHINA
25959 A IV 4/10/2012 FONA INTERNATIONAL INC 926.0701U FONATECH VANILLA TYPE FLAVOR, NAT (CFT) AS MANUFACTURED IN
GENEVA, IL
25960 A III 3/1/2012 EASTMAN CHEMICAL CO EASTMAN 168 NON-PHTHALATE PLASTICIZER PRODUCTION AS MANUFACTURED IN
TEXAS CITY, TX
Page 778
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25961 A II 10/31/2013 MALLINCKRODT INC HYDROCODONE BITARTRATE USP CRYSTALS(NP) (ESUB) AS MANUFACTURED IN ST.
LOUIS, MISSOURI
25962 P *** PENDING FILING REVIEW ***
25963 A II 3/6/2012 SWATI SPENTOSE PRIVATE LTD LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA
25964 A II 3/27/2012 PARABOLIC DRUGS LTD DEFERASIROX AS MANUFACTURED IN HARYANA, INDIA
25965 A III 4/12/2012 SEKISUI ALVEO AG ALVEOLIT TA SRZ POLYMER FOAMS AS MANUFACTURED IN LUCERNE, SWITZERLAND
25966 A IV 4/10/2012 ILE PHARMACEUTICAL MATERIALS CO LTD COMPLETE FILM COATING SYSTEMS AS MANUFACTURED IN TIANJIN, CHINA
25967 A IV 4/12/2012 SYMRISE INC 910009 EVOSPRAY NATURAL LIME FLAVOR WONF AS MANUFACTURED IN TETERBORO,
NJ AND BRANCHBURG, NJ FOR SYMRISE INC
25968 A II 3/15/2012 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM ACID (PROCESS V, NON-STERILE API) AS MANUFACTURED IN JINAN,
CHINA
25969 A II 4/2/2012 SEKISUI ALVEO AG ALVEOLIT TL SRZ AS MANUFACTURED IN LUCERNE, SWITZERLAND
25970 A II 4/12/2012 INCELL CORP LLC ZSOL:F, ZSOL:M AND ZSOL:MH BIOPROCESSING BUFFER FAMILY AS MANUFACTURED IN
SAN ANTONIO, TX
25971 A III 4/10/2012 SCG PERFORMANCE CHEMICALS CO LTD POLYPROPYLENE EL-PRO P655IM AS MANUFACTURED IN RAYONG, THAILAND FOR SCG
PERFORMANCE CHEMICALS CO., LTD.
25972 P *** PENDING FILING REVIEW ***
25973 A II 4/16/2012 LABORATORIO CHIMICO INTERNAZIONALE
SPA
ETHACRYNIC ACID AS MANUFACTURED IN SEGRATE MI ITALY
25974 A III 4/17/2012 JAPAN POLYPROPYLENE CORP NOVATEC/WELNEX/WINTEC PP SERIES AS MANUFACTURED IN MIE, JAPAN FOR JAPAN
POLYPROPYLENE CORPORATION
25975 A IV 4/10/2012 HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL CHERRY FLAVOR #5578 AS MANUFACTURED IN PHILADELPHIA, PA
25976 A II 4/23/2012 AUROBINDO PHARMA LTD PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
25977 A V 4/17/2012 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATION AS LOCATED IN
TRIBIANO (MI), ITALY
25978 A II 5/16/2012 RELIANCE LIFE SCIENCES PVT LTD ERLOTINIB HYDROCHLORIDE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
25979 A IV 5/5/2012 SUNIL HEALTHCARE LTD EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTHAN, INDIA
25980 A II 4/16/2012 SYN TECH CHEM AND PHARM CO LTD GRANISETRON BASE AS MANUFACTURED IN TAINAN CITY, TAIWAN
25981 A III 4/13/2012 NOLATO JAYCARE LTD 60, 75 AND 100ML HDPE WHITE ROUND BOTTLES AS MANUFACTURED IN NEWCASTLE
UPON TYNE, ENGLAND
25982 A II 4/18/2012 ZHEJIANG GUOBANG PHARMACEUTICAL CO
LTD
CLARITHROMYCIN USP AS MANUFACTURED IN ZHEJIANG, P. R. CHINA
25983 I II 4/19/2012 CHEMI SPA ZOLEDRONIC ACID HEMIPENTAHYDRATE AS MANUFACTURED IN FROSINONE, ITALY
25984 A IV 4/23/2012 BHARAT STARCH INDUSTRIES SODIUM STARCH GLYCOLATE USP AS MANUFACTURED IN YAMUNA NAGAR, INDIA
25985 A III 4/20/2012 ST GOBAIN PERFORMANCE PLASTICS CORP SANI-TECH ULTRA 65 SILICONE TUBING AS MANUFACTURED IN TAUNTON, MA
25986 A II 4/20/2012 RA CHEM PHARMA LTD ITRACONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
25987 A II 4/23/2012 HOVIONE FARMACIENCIA SA MOMETASONE FUROATE MONOHYDRATE INHALATION GRADE AS MANUFACTURED IN
LOURES, PORTUGAL
25988 A II 4/23/2012 CQ INTERNATIONAL CO INC DECITABINE JIANGSU, CHINA FOR CQ INTERNATIONAL CO. INC.
25989 A II 4/13/2012 CAMBREX PROFARMACO MILANO SRL EPINEPHRINE AS MANUFACTURED IN MILAN, ITALY
25990 A III 4/25/2012 MPI RELEASE RELEASE LINER 2-MIL PET C1S 15-0121 AS MANUFACTURED IN GREENFIELD, IN
Page 779
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25991 A IV 4/20/2012 SYNKEM SAS SODIUM STEARYL FUMARATE AS MANUFACTURED IN CHENOVE, FRANCE
25992 A II 4/28/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD FLUVASTATIN SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
25993 A II 5/7/2012 SRI KRISHNA PHARMACEUTICALS LTD GLIPIZIDE USP AS MANUFACTURED IN MEDAK DIST, A.P, INDIA
25994 N NOT AN ASSIGNED NUMBER
25995 A III 4/25/2012 MITSUI CHEMICALS INC APEL APL6011T, APL6013T, APL6015T, APL6509T, AND APL8008T AS MANUFACTURED IN
OSAKA, JAPAN
25996 A II 4/24/2012 ZHEJIANG JINHUA CONBA BIO PHARM CO
LTD
ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE
25997 A III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 62 YELLOW MADE WITH PLATINUM CURE CHEMISTRY
ON YELLOW GLASSINE AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
25998 A III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 62 WHITE MADE WITH PLATINUM CURE CHEMISTRY ON
WHITE GLASSINE AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
25999 A III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 80 MADE WITH PLATINUM CURE CHEMISTRY ON
GLASSINE PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
26000 A III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 90 MADE WITH PLATINUM CURE CHEMISTRY ON
GLASSINE PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
26001 A III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 120 MADE WITH PLATINUM CURE CHEMISTRY ON
GLASSINE PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA
26002 A III 4/24/2012 AMPACET CORP 455899 RED SMC PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA,
CARTERSVILLE GA AND HEATH OH
26003 A II 4/19/2012 BACHEM SA DEFERASIROX AS MANUFACTURED IN VIONNAZ,SWITZERLAND
26004 A II 4/20/2012 PIRAMAL ENTERPRISES LTD SULINDAC AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26005 A II 8/12/2012 SUZHOU APAC PHARMATECH CO LTD EWJPB, API AS MANUFACTURED IN WUJIANG CITY, CHINA
26006 A V 5/25/2013 HALOZYME THERAPEUTICS INC PRE-CLINICAL AND LABORATORY INFORMATION (RHUPH20) (ESUB)
26007 A III 4/27/2012 CONSOLIDATED BOTTLE CORP 20ML NATURAL EUROPEAN DOSAGE CUP PP ROUND, GRADUATED (2.5ML TO 20ML) AS
MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION
26008 A III 4/25/2012 CLARIANT PRODUCTION FRANCE SORB-IT PACKETS AS MANUFACTURED IN SAINT-MAMMES -FRANCE
26009 A II 3/21/2012 QILU TIANHE PHARMACEUTICAL CO LTD PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (STERILE API) AS
MANUFACTURED IN JINAN, CHINA
26010 A III 4/11/2012 CHROMA CORP PC85234B BLACK COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL
26011 P *** PENDING FILING REVIEW ***
26012 P *** PENDING FILING REVIEW ***
26013 A II 6/1/2012 APICORE LLC ETHACRYNIC ACID USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26014 A III 5/1/2012 BOEHRINGER INGELHEIM PHARMA GMBH
AND CO KG
CONTAINER CLOSURE FOR RESPIMAT AQUEOUS SOLUTIONS AS MANUFACTURED IN
INGELHEIM AM RHEIN, GERMANY
26015 A III 5/1/2012 BOEHRINGER INGELHEIM MICROPARTS
GMBH
RESPIMAT INHALER FOR AQUEOUS SOLUTIONS AS MANUFACTURED IN DORTMUND,
GERMANY
26016 A II 4/30/2012 CERBIOS PHARMA SA (6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT AS MANUFACTURED IN
BARBENGO/LUGANO, SWITZERLAND
26017 A II 5/2/2012 HETERO DRUGS LTD RIZATRIPTAN BENZOATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26018 A II 7/13/2012 SUN PHARMACEUTICAL INDUSTRIES LTD CAPECITABINE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26019 A II 5/22/2012 FRESENIUS KABI ONCOLOGY LTD TEMSIROLIMUS (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA
26020 A II 5/2/2012 SYMBIOTEC PHARMALAB LTD ETHINYL ESTRADIOL, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
Page 780
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26021 A II 5/2/2012 SYMBIOTEC PHARMALAB LTD ETHYNODIOL DIACETATE, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
26022 A II 4/28/2012 ZHEJIANG NEO DANKONG
PHARMACEUTICAL CO LTD
ATORVASTATIN CALCIUM, NON-STERILE BULK DRUG SUBSTANCES AS MANUFACTURED
IN TAIZHOU, CHINA
26023 A II 4/25/2012 MYLAN LABORATORIES LTD DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26024 A II 5/3/2012 MSN LABORATORIES LTD ESMOLOL HYDROCHLORIDE [ROUTE CODE: "EH"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26025 A II 4/20/2012 AVRA LABORATORIES PRIVATE LTD 10-HYDROXYCAMPTOTHECIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26026 A II 5/8/2012 PROTEUS SA NEOSAXITOXIN 200G/ML AS MANUFACTURED IN SANTIAGO, CHILE
26027 A II 4/25/2012 KONDUSKAR LABORATORIES PVT LTD OXCARBAZEPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
26028 A II 5/5/2012 DIVIS LABORATORIES LTD TELMISARTAN, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26029 A II 5/8/2012 MAC CHEM PRODUCTS INDIA PVT LTD CARBOPLATIN USP AS MANUFACTURED IN DISTRICT THANE, INDIA
26030 A II 5/8/2012 LIVZON GROUP FUZHOU FUXING
PHARMACEUTICAL CO LTD
VANCOMYCIN HYDROCHLORIDE, LYOPHILIZED AS MANUFACTURED IN FUZHOU CITY,
CHINA
26031 A II 4/27/2012 KREATIVE ORGANICS P LTD SALSALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26032 A II 8/16/2012 EXCELLA GMBH TEMOZOLOMIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY
26033 A II 5/23/2012 IPCA LABORATORIES LTD CETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS) (ESUB) AS MANUFACTURED IN
MADHYA PRADESH, INDIA
26034 A III 11/15/2010 INGENIA POLYMERS CORP INGENIA POLYMERS 1023 FILLED WHITE AS MANUFACTURED IN ONTARIO, CANADA;
ALBERTA, CANADA; HOUSTON, TEXAS FOR INGENIA POLYMERS CORPORATION
26035 A II 6/1/2012 AUROBINDO PHARMA LTD OLMESARTAN MEDOXOMIL USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26036 A III 5/4/2012 LEVOSIL SPA DESICCANT BAGS AS MANUFACTURED IN CHIUSA SAN MICHELE (TO), ITALY
26037 I II 5/7/2012 JIANGSU HENGRUI MEDICINE CO LTD MESNA USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU,
CHINA
26038 A II 5/9/2012 NEULAND LABORATORIES LTD BOSENTAN MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26039 A II 5/7/2012 BLOOMAGE FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-P-0.5) AS MANUFACTURED IN JINAN CITY, P. R. OF CHINA
26040 A IV 5/8/2012 SYMRISE INC 992583 NATURAL PEPPERMINT FLAVOR POWDER 605030 AS MANUFACTURED IN
TETERBORO, NJ AND BRANCHBURG, NJ
26041 A II 5/11/2012 JIANGSU HENGRUI MEDICINE CO LTD CYCLOPHOSPHAMIDE, USP, STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
JIANGSU, CHINA
26042 A II 5/8/2012 RAKS PHARMA PVT LTD LINEZOLID AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26043 A II 1/31/2013 CHONGQING SHENGHUAXI
PHARMACEUTICAL CO LTD
FEBUXOSTAT (ESUB) AS MANUFACTURED IN CHONGQING, CHINA
26044 A II 5/15/2012 HETERO LABS LTD ETORICOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26045 A II 5/15/2012 HETERO DRUGS LTD ZIPRASIDONE HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26046 A IV 5/3/2012 FRUTAROM USA NATURAL & ARTIFICIAL BLACKBERRY FLAVOR 3251351091.00 AS MANUFACTURED IN
CORONA, CA
26047 A II 6/8/2012 UNIMARK REMEDIES LTD CEFIXIME USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26048 A II 5/23/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD SIMVASTATIN (BHA ADDED) (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
26049 A II 6/14/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DEMECLOCYCLINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TAIZHOU CITY,
CHINA
Page 781
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26050 A II 7/20/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MINOCYCLINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
26051 A III 4/23/2012 SHREE NAINA POLYMERS INC PET BOTTLES AS MANUFACTURED IN HIMACHAL PRADESH, INDIA
26052 A II 5/14/2012 SIEGFRIED LTD BUPRENORPHINE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND
26053 A III 4/25/2012 SUN PACKMET PRIVATE LTD PLAIN/PRINTED ALUMINIUM FOILS (STRIP/BLISTER) AS MANUFACTURED IN HIMACHAL
PRADESH, INDIA
26054 A IV 5/16/2012 CAPSUGEL MANUFACTURING INC COMPLIANCE IDENTIFIER CAPSULES AS MANUFACTURED IN GRAFFENSTADEN, FRANCE
AND CAMBRIDGE, MA
26055 A V 7/27/2012 ENTERIS BIOPHARMA INC 3-O-LAUROYL-L-CARNITINE HYDROCHLORIDE (LLC) PRECLINICAL AND CLINICAL DATA
(ESUB)
26056 A II 8/31/2012 PRONOVA BIOPHARMA NORGE AS OMEGA-3-ACID ETHYL ESTERS, (ESUB) AS MANUFACTURED IN SANDEFJORD, NORWAY
AND KALUNDBORG, DENMARK
26057 A IV 5/14/2012 WILSHIRE TECHNOLOGIES INC PHYTOSQUENE AS MANUFACTURED IN CHARLES CITY, IOWA FOR WILSHIRE
TECHNOLOGIES INC
26058 A III 4/23/2012 SHREE NAINA PACKWELL INC GLASS AMPOULES AND VIALS AS MANUFACTURED IN HIMACHAL PRADESH, INDIA
26059 A II 5/25/2012 AMPHASTAR NANJING PHARMACEUTICALS
INC
SEMI-PURIFIED HEPARIN SODIUM (ESUB) AS MANUFACTURED IN JIANGSU CHINA
26060 A V 5/15/2012 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AS
MANUFACTURE IN MILAN, ITALY - VALE ADDETTA PLANT - LYOPHILIZATION PLANT NO, 2
26061 A II 5/9/2012 QILU PHARMACEUTICAL CO LTD EXEMESTANE (NON-STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE PR
CHINA FOR QILU PHARMACEUTICAL CO LTD
26062 A II 5/2/2012 KOPRAN LTD PREGABALIN AS MANUFACTURED IN MAHARASHTRA INDIA
26063 A II 5/17/2012 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
LCA45 AS MANUFACTURED IN ZHEJIANG CHINA
26064 A II 5/19/2012 INDO PHYTO CHEMICALS PRIVATE LTD LEVONORGESTREL USP AS MANUFACTURED IN UTTRAKHAND INDIA
26065 A II 5/11/2012 PIRAMAL ENTERPRISES LTD APREPITANT AS MANUFACTURED IN ANDHRA PRADESH INDIA
26066 A II 5/15/2012 NORTH CHINA PHARMACEUTICAL GROUP
SEMISYNTECH CO LTD
AMOXICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P. R. CHINA
26067 A II 5/18/2012 MAPRIMED SA ZOLEDRONIC ACID MONOHYDRATE (CODE 50787) AS MANUFACTURED IN BUENOS
AIRES, ARGENTINA
26068 A II 5/17/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD EZETIMIBE AS MANUFACTURED IN UTTAR PRADESH, INDIA FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
26069 A IV 4/26/2012 TIANJIN KAIWEI AND YONGLI UNITED
CHEMICAL CO LTD
WHITE MINERAL OIL AS MANUFACTURED IN TIANJIN, CHINA
26070 A II 6/15/2012 INTERNATIONAL MEDICATION SYSTEMS LTD HEPARIN SODIUM USP (ESUB) AS MANUFACTURED IN SOUTH EL MONTE, CA
26071 A II 5/31/2012 CADILA HEALTHCARE LTD FEBUXOSTAT API (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26072 A II 7/2/2012 CADILA HEALTHCARE LTD OLANZAPINE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26073 A II 5/31/2012 CADILA HEALTHCARE LTD ROSUVASTATIN CALCIUM API (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26074 A II 5/22/2012 HETERO DRUGS LTD MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26075 A II 5/18/2012 CHEMWERTH INC ARSENIC TRIOXIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
FREIBURG, GERMANY FOR CHEMWERTH INC
26076 A II 5/21/2012 SEQUENT SCIENTIFIC LTD PRAZIQUENTEL AS MANUFACTURED IN KARNATAKA, INDIA
26077 A II 6/13/2012 WATSON PHARMA PRIVATE LTD OXYBUTYNIN BASE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26078 A II 5/22/2012 MSN LABORATORIES LTD UNIT II CAPECITABINE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 782
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26079 A II 5/23/2012 HETERO DRUGS LTD VALGANCICLOVIR HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH,
INDIA FOR HETERO DRUGS LIMITED
26080 A II 5/22/2012 HETERO DRUGS LTD FENOFIBRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26081 A II 5/14/2012 CAYMAN PHARMA SRO LATANOPROST AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC
26082 A II 5/18/2012 NAGAOKA AND CO LTD MENTHA OIL JP AS MANUFACTURED IN HYOGO, JAPAN
26083 A II 5/24/2012 SHASUN PHARMACEUTICALS LTD TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN CUDDALORE, INDIA
26084 A II 5/22/2012 RAKS PHARMA PVT LTD ATORVASTATIN CALCIUM STABILIZED AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26085 A II 6/28/2012 GLENMARK GENERICS LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26086 A II 5/24/2012 SIGMA ALDRICH MANUFACTURING LLC HYALURONIDASE AS MANUFACTURED IN ST LOUIS MO
26087 A II 5/23/2012 RAKS PHARMA PVT LTD DEXLANSOPRAZOLE API AS MANUFACTURED IN ANDHRA PRADESH INDIA
26088 A II 5/16/2012 ZHEJIANG JIANGBEI PHARMACEUTICAL CO
LTD
SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS) AS MANUFACTURED IN
TAIZHOU CITY, CHINA
26089 A III 5/21/2012 SMITHS MEDICAL ASD INC ENTERAL MEDICATION CASSETTE RESERVOIR AS MANUFACTURED IN TIJUANA MEXICO
FOR SMITHS MEDICAL ASD INC
26090 A III 5/30/2012 LUXFER GAS CYLINDERS COMPRESSED GAS CYLINDER PACKAGE (ALTERNATIVE PROCESS) AS MANUFACTURED
IN GRAHAM, NC
26091 A II 12/30/2013 HUBEI HONCH PHARMACEUTICAL CO LTD VINORELBINE TARTRATE (ESUB) AS MANUFACTURED IN QICHUN COUNTY, CHINA
26092 A IV 4/23/2012 GC CHEMIE PHARMIE LTD NOVOCOAT - HYPROMELLOSE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA
26093 A IV 4/23/2012 GC CHEMIE PHARMIE LTD NOVODONE-CR CROSPOVIDONE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA
26094 A IV 4/23/2012 GC CHEMIE PHARMIE LTD NOVODONE POVIDONE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA
26095 A III 5/30/2012 JIANGSU HUALAN NEW PHARMACEUTICAL
MATERIAL CO LTD
BUTYL RUBBER STOPPERS COVERED WITH POLYSTER FILMS AS MANUFACTURED IN
JIANGSU PROVINCE CHINA
26096 A III 5/22/2012 BORMIOLI ROCCO SPA BU PLASTICA SPECIAL CHILD-PROOF CP O28 MM AS MANUFACTURED IN CASTELGUELFO (PR), ITALY;
RIVANAZZANO (PV), ITALY; SAINT SULPICE, FRANCE FOR BORMIOLI ROCCO S.P.A. - B.U.
PLASTICA
26097 A II 5/26/2012 ZHEJIANG TIANYU PHARMACEUTICAL CO
LTD
MONTELUKAST BACKONE DIOL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
26098 A II 6/8/2012 MEIJI SEIKA PHARMA CO LTD ARBEKACIN FREE BASE DRUG SUBSTANCE (ME1100) AS MANUFACTURED IN IWATE,
JAPAN AND KANAGAWA-KEN, JAPAN
26099 A II 5/30/2012 HETERO DRUGS LTD ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26100 A II 5/30/2012 HETERO DRUGS LTD SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26101 A II 5/18/2012 BIOCON LTD ORLISTAT AS MANUFACTURED IN BANGALORE, INDIA
26102 A II 9/7/2012 AUROBINDO PHARMA LTD ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED
IN ANDHRA PRADESH, INDIA
26103 A II 11/28/2012 TARO PHARMACEUTICAL INDUSTRIES LTD PROGUANIL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL
26104 A II 5/30/2012 OLON SPA ASENAPINE MALEATE AS MANUFACTURED IN RODANO (MI), ITALY
26105 A II 9/30/2012 EMCURE PHARMACEUTICALS LTD ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26106 A III 5/15/2012 EQUISTAR CHEMICALS LP A
LYONDELLBASELL INDUSTRIES CO
POLYPROPYLENE RESINS FOR MEDICAL APPLICATIONS AS MANUFACTURED IN
PASADENA, TX AND WEST LAKE, LA FOR EQUISTAR CHEMICALS, LP, A LYONDELLBASELL
INDUSTRIES COMPANY
26107 A II 5/31/2012 HUBEI HAOSUN PHARMACEUTICAL CO LTD OXALIPLATIN AS MANUFACTURED IN HUBEI, CHINA
26108 A II 5/31/2012 CATALENT PHARMA SOLUTIONS LLC WC3042-08P CAPSULE AS MANUFACTURED IN ST PETERSBURG FL
Page 783
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26109 A II 5/30/2012 MINSHENG GROUP SHAOXING
PHARMACEUTICAL CO LTD
ALENDRONATE SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA
26110 A II 5/31/2012 CATALENT PHARMA SOLUTIONS LLC WC3042-05, CAPSULE AS MANUFACTURED IN ST.PETERSBURG, FLORIDA
26111 A II 5/29/2012 ZHUHAI UNITED LABORATORIES CO LTD POTASSIUM CLAVULANATE - MICROCRYSTALLINE CELLULOSE (1:1) AS MANUFACTURED
IN GUANGDONG PR CHINA
26112 A II 5/31/2012 CAMBREX CHARLES CITY INC DICLOFENAC EPOLAMINE AS MANUFACTURED IN CHARLES CITY, IA
26113 A II 6/4/2012 HETERO DRUGS LTD TETRABENAZINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26114 A II 5/28/2012 ZHUHAI UNITED LABORATORIES CO LTD CEFUROXIME SODIUM USP AS MANUFACTURED IN GUANGDONG PR CHINA
26115 A II 5/28/2012 ZHUHAI UNITED LABORATORIES CO LTD CEFOPERAZONE SODIUM USP AS MANUFACTURED IN GUANGDONG PR CHINA
26116 A II 6/4/2012 HETERO LABS LTD ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26117 A II 5/30/2012 MYLAN LABORATORIES LTD ADEFOVIR DIPIVOXIL AS MANUFACTURED IN MAHARASHTRA, INDIA
26118 A III 6/1/2012 KYODO PRINTING CO LTD MOISTCATCH SERIES FOR MOISTURE ABSORBING MATERIAL AS MANUFACTURED IN
IBARAKI JAPAN
26119 A IV 6/1/2012 THE NIPPON SYNTHETIC CHEMICAL
INDUSTRY CO LTD
GOHSENOL EG AS MANUFACTURED IN KUMAMOTO JAPAN
26120 A IV 6/1/2012 FONA INTERNATIONAL INC 825.0047U CHERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL
26121 P *** PENDING FILING REVIEW ***
26122 A II 6/4/2012 HETERO LABS LTD ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26123 A II 5/28/2012 SHARON BIO MEDICINE LTD TELMISARTAN USP AS MANUFACTURED MAHARASHTRA, INDIA
26124 A III 5/31/2012 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL PAPER/OPA/ALUMINIUM/ION AS MANUFACTURED IN
BURGDORF, SWITZERLAND
26125 A II 6/4/2012 CRYSTAL PHARMA LTD SOLIFENACIN SUCCINATE AS MANUFACTURED IN ZEJTUN, MALTA
26126 A II 6/4/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD AZACITIDINE AS MANUFACTURED IN VERCELLY, ITALY FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
26127 A II 6/5/2012 POSH CHEMICALS PRIVATE LTD SULFASALAZINE USP AS MANUFACTURED IN HYDERABAD, INDIA
26128 A II 6/5/2012 DAIICHI FINE CHEMICAL CO LTD TRANEXAMIC ACID DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN
26129 A II 6/5/2012 TRIFARMA SPA COLOCORTOLONE PIVALATE AS MANUFACTURED IN CERIANO LAGHETTO (MB) ITALY
FOR
26130 A II 5/30/2012 SARV BIO LABS PVT LTD THIOCOLCHICOSIDE AS MANUFACTURED IN PARDESH, INDIA
26131 A II 6/6/2012 HETERO DRUGS LTD GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26132 A II 5/25/2012 SHANDONG XINHUA PHARMACEUTICAL CO
LTD
AMLODIPINE BESYLATE AS MANUFACTURED IN SHANDONG, PR CHINA
26133 A II 5/14/2012 BETTS INDIA PRIVATE LTD LAMINATED TUBES USED FOR PACKAGING AS MANUFACTURED IN GOA, INDIA
26134 P *** PENDING FILING REVIEW ***
26135 A II 6/5/2012 POLYONE CORP CC10161654XX (AMBER ARCH) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
26136 A II 6/7/2012 HETERO DRUGS LTD LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26137 A II 6/8/2012 SCI PHARMTECH, INC. CYCLOPHOSPHAMIDE AS MANUFACTURED IN TAOYUAN, TAIWAN
26138 A II 6/27/2012 ALEMBIC PHARMACEUTICALS LTD API DIV DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26139 A II 4/5/2013 MACLEODS PHARMACEUTICALS LTD TADALAFIL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26140 A III 5/31/2012 ST GOBAIN PERFORMANCE PLASTICS CORP POLYESTER FILM C/1/S WITH 4130 SILICONE RELEASE COATING, POLYESTER FILM C/1/S
WITH 4140 SILICONE RELEASE COATING AS MANUFACTURED IN WORCESTER,
MASSACHUSETTS
Page 784
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26141 A III 6/8/2012 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT MASTERBATCHES B24338 BLUE 286C, E16055
GREEN 369C AND W05255 WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, ILLINOS
26142 A II 6/8/2012 NERPHARMA SRL BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE AS
MANUFACTURED IN MILAN, ITALY
26143 A II 4/28/2012 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ZHEJIANG, CHINA
26144 A II 7/17/2012 UBE INDUSTRIES LTD DS-1442B DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN YAMAGUCHI, JAPAN
26145 A II 7/2/2012 CADILA HEALTHCARE LTD PHENTERMINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26146 A II 4/18/2011 SIGNA SA DE CV GEMFIBROZIL USP (GEA PROCESS) AS MANUFACTURED IN TOLUCA, MEXICO
26147 A II 6/8/2012 STANDARD CHEMICAL AND
PHARMACEUTICAL CO LTD
RILUZOLE AS MANUFACTURED IN TAINAN CITY, TAIWAN
26148 A II 6/12/2012 FARMABIOS S P A FLUNISOLIDE HEMIHYDRATE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI
(PV) ITALY
26149 A III 5/25/2012 MEGAPLAST GMBH AIRLESS PUMP DISPENSERS AS MANUFACTURED IN VILLINGEN SCHWENNINGEN
GERMANY
26150 A II 2/8/2012 APOTEX PHARMACHEM INC ROSUVASTATIN CALCIUM (ROS) AS MANUFACTURED IN BRANTFORD ONTARIO, CANADA
AND TOLUCA ESTADO DE, MEXICO FOR APOTEX PHARMACHEM INC
26151 A II 6/9/2012 MSN PHARMACHEM PVT LTD MILNACIPRAN HYDROCHLORIDE [ROUTE CODE-"MR"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26152 A III 5/29/2012 CCC PLASTICS CANADA COLORS AND
CHEMICALS LTD
WHITE MB50-936 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN
ONTARIO, CANADA
26153 A II 6/1/2012 SYMBIOTICA SPECIALITY INGREDIENTS SDN
BHD
MOMETASONE FUROATE AS MANUFACTURED IN KEDAH, MALAYSIA
26154 A III 5/23/2012 SIPPEX POLYPROPYLENE BAGS WITH CONNECTORS AS MANUFACTURED IN COURZIEU, FRANCE
26155 A III 5/23/2012 SIPPEX PVC BAGS WITH CONNECTORS AS MANUFACTURED IN COURZIEU, FRANCE
26156 A II 6/8/2012 MSN LABORATORIES LTD AMBRISENTAN [ROUTE CODE - "AB"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26157 A IV 6/13/2012 GM CHEMIE PVT LTD CELLULOSE ACETATE PHTHALATE (CELLACEFATE) USP AS MANUFACTURED IN
MAHARASHTRA, INDIA
26158 A II 5/28/2012 PARABOLIC DRUGS LTD BOSENTAN MONOHYDRATE AS MANUFACTURED IN HARYANA, INDIA
26159 A II 6/15/2012 CKD BIO CORP RIFAMYCIN O, NON-STERILE API AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA
26160 A II 6/11/2012 APTALIS PHARMATECH INC TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG AS MANUFACTURED IN
VANDALIA, OHIO
26161 A II 6/11/2012 APTALIS PHARMATECH INC EMTRICITABINE RAPIDLY DISINTEGRATING TABLETS, 40 MG AS MANUFACTURED IN
VANDALIA, OHIO
26162 A II 6/11/2012 APTALIS PHARMATECH INC EMTRICITABINE AND TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG/40 MG AS
MANUFACTURED IN VANDALIA, OHIO
26163 A II 6/11/2012 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
VENLAFAXINE HYDROCHLORIDE CRYSTALLINE FORM B (VERSION NUMBER: 1) AS
MANUFACTURED IN ZHEJIANG, CHINA
26164 A II 6/7/2012 CENTAUR PHARMACEUTICALS PRIVATE LTD ES-ZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA
26165 A III 6/15/2012 ZHONGSHAN CITY CONSTRONG MEDICAL
PACKAGING MATERIAL CO LTD
NON-PVC MEDICAL PACKING FILM AS MANUFACTURED IN GUANGDONG, CHINA
26166 A II 6/19/2012 SYMBIOTEC PHARMALAB LTD TESTOSTERONE ENANTHATE, USP AS MANUFACTURED IN MADHYA PRADESH (M.P.),
INDIA
26167 A II 7/7/2012 CADILA PHARMACEUTICALS LTD VALSARTAN USP (PROCESS 2) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
Page 785
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26168 A IV 6/6/2012 JC BIOLOGY TECHNOLOGY CO LTD BRIGHT POLY UNFILLED HARD SHELL PULLULAN CAPSULES AS MANUFACTURED IN
SHANXI PROVINCE, CHINA
26169 A V 6/15/2012 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AS STERILE PROCESSING OPERATIONS, AND LOCATED
IN MILANO, ITALY- VIALE ADDETTA PLANT- LYOPHILIZATION PLANT NO.1
26170 A II 1/23/2013 CIPLA LTD IMATINIB MESYLATE (A-FORM) (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
26171 P *** PENDING FILING REVIEW ***
26172 A II 6/7/2012 CHONGQING PHAR SCIN CO LTD HYDROTALCITE NON STERILE, DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING
CITY, P.R. CHINA
26173 A II 10/26/2012 SUN PHARMACEUTICAL INDUSTRIES LTD FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26174 A II 10/9/2012 SUN PHARMACEUTICAL INDUSTRIES LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
26175 A V 7/16/2012 CORDEN PHARMA LATINA SPA ASEPTIC ONCOLOGICAL FACILITY (ESUB) AS MANUFACTURED IN SERMONETA (LATINA),
ITALY
26176 A II 6/28/2012 UNIMARK REMEDIES LTD NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS) (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
26177 A II 7/13/2012 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
ALMOTRIPTAN MALATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26178 A II 6/22/2012 HETERO DRUGS LTD RITONAVIR PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26179 A II 6/25/2012 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
26180 A II 6/22/2012 DELTA BIOTECH SA TRAVOPROST AS MANUFACTURED IN BUENOS AIRES, ARGENTINA
26181 A II 6/22/2012 DELTA BIOTECH SA LATANOPROST AS MANUFACTURED IN BUENOS AIRES, ARGENTINA
26182 A II 7/11/2012 GLOPEC INTERNATIONAL INC ACITRETIN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR GLOPEC
INTERNATIONAL INC
26183 A II 6/26/2012 CRYSTAL PHARMA SAU ETHINYL ESTRADIOL AS MANUFACTURED IN VALLADOLID, SPAIN
26184 A II 6/28/2012 ASENCE PHARMA PRIVATE LTD AMPHOTERICIN B USP [ORAL GRADE] AS MANUFACTURED IN GUJARAT, INDIA FOR
ASENCE PHARMA PRIVATE LIMITED
26185 A II 6/28/2012 HETERO LABS LIMITED ESCITALOPRAM OXALATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26186 A V 6/26/2012 LONZA AG POTENT COMPOUND PRODUCTION (PCP) FACILITY AT LONZA VISP SITE
26187 P *** PENDING FILING REVIEW ***
26188 A IV 6/29/2012 FONA INTERNATIONAL INC 825.0062U N-C CHERRY BERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
26189 A II 6/29/2012 FRESENIUS KABI ANTI INFECTIVES SRL HETACILLIN POTASSIUM STERILE AS MANUFACTURED IN CERNUSCO SUL NAVIGLIO (MI),
ITALY AND VILLADOSE (RO), ITALY
26190 A II 6/14/2012 FIS FABBRICA ITALIANA SINTETICI SPA SOLIFENACIN SUCCINATE AS MANUFACTURED IN ALTE DI MONTECCHIO MAGGIORE,
ITALY
26191 A II 6/29/2012 CRYSTAL PHARMA SAU CLOBETASOL PROPIONATE MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN
26192 A II 7/3/2012 AARTI DRUGS LTD PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
26193 A III 6/25/2012 AMPACET CORP 11078-E WHITE PE MB AS MANUFACTURED IN MESSANCY, BELGIUM
26194 A II 6/25/2012 WATERSTONE PHARMACEUTICALS HUBEI
CO LTD
LEVETIRACETAM AS MANUFACTURED IN HUBEI PROVINCE, CHINA
26195 A II 7/2/2012 NEULAND LABORATORIES LTD PALIPERIDONE PALMITATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26196 A IV 7/3/2012 JSR LIFE SCIENCES CORP STYRENE ISOPRENE BLOCK COPOLYMER AS MANUFACTURED IN IBARAKI, JAPAN
26197 A IV 8/16/2012 LIFECELL INTERNATIONAL PRIVATE LTD DMSO 55%W/V DEXTRAN-40 5%W/V SOLUTION (ESUB) AS MANUFACTURED IN CHENNAI,
INDIA
26198 A II 7/10/2012 CTX LIFE SCIENCES PVT LTD OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
Page 786
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26199 A V 6/28/2012 PIRAMAL HEALTHCARE UK LTD GRANGEMOUTH SITE (SUITE 5)
26200 A II 7/3/2012 UNION QUIMICO FARMACEUTICA SA UQUIFA
SA
LINEZOLID AS MANUFACTURED IN BARCELONA, SPAIN
26201 A III 6/8/2012 AMI POLYMERS PVT LTD SILICON TUBES & BRAIDED HOSES (PLATINUM CURED & PEROXIDE CURED) AS MIRA
ROAD AND SILVASSA, INDIA
26202 A II 7/5/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD ANASTROZOLE AS MANUFACTURED IN SICHUAN, CHINA
26203 A III 3/26/2012 REXAM HEALTHCARE OFFRANVILLE SAS EYE DROPPERS SETS (10ML LDPE BOTTLE+ LDPE NOZZLE + PP CAPS) AS
MANUFACTURED IN OFFRANVILLE, FRANCE
26204 A II 7/9/2012 HETERO DRUGS LTD DORZOLAMIDE HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26205 A II 6/29/2012 PCI SYNTHESIS PCI-114234 AS MANUFACTURED IN NEWBURYPORT, MASSACHUSETTS
26206 A II 7/10/2012 HETERO DRUGS LTD SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26207 A II 7/10/2012 HETERO LABS LTD PAZOPANIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26208 I II 6/29/2012 JARI PHARMACEUTICAL CO LTD TORSEMIDE AS MANUFACTURED IN JIANGSU, CHINA
26209 A II 10/23/2012 GLENMARK GENERICS LTD RUFINAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26210 A II 9/27/2012 CADILA PHARMACEUTICALS LTD RUPATADINE FUMARATE (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
26211 A IV 7/5/2012 TAKASAGO INTERNATIONAL CORP CHERRY MICRON OT-22685 AS MANUFACTURED IN SHIZAUOKA, JAPAN
26212 A IV 7/5/2012 TAKASAGO INTERNATIONAL CORP CHERRY FLAVOR OT-83853 AS MANUFACTURED IN KANAGAWA, JAPAN
26213 A II 8/5/2012 AVA, INC. CHLORHEXIDINE GLUCONATE 20% SOLUTION, USP (ESUB) AS MANUFACTURED IN
WILLOWBROOK, IL
26214 A II 11/9/2012 LUPIN LTD ATORVASTATIN CALCIUM AMORPHOUS (ESUB) AS MANUFACTURED IN GUJRAT, INDIA
26215 A II 2/6/2013 LUPIN LTD ATORVASTATIN CALCIUM TRIHYDRATE USP (ESUB) AS MANUFACTURED IN GUJRAT,
INDIA
26216 A III 9/18/2012 EMPHASYS INDUSTRIAL CDM-HALER (ESUB) AS MANUFACTURED IN BOITUVA/SP, BRAZIL FOR EMPHASYS
INDUSTRIAL
26217 A II 7/12/2012 HETERO DRUGS LTD FEBUXOSTAT (FORM-H1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26218 A II 7/12/2012 DELAVAU LLC CALCIUM CARBONATE/MAGNESIUM HYDROXIDE GRANULATION AS MANUFACTURED IN
PHILADELPHIA, PENNSYLVANIA
26219 A IV 7/11/2012 FUJI SILYSIA CHEMICAL LTD SYNTHETIC AMORPHOUS SILICA PRODUCTS - SYLYSIA/ADSOLIDER AS MANUFACTURED
IN MIYAZAKI-KEN, JAPAN
26220 A IV 7/5/2012 UNGERER AND CO ARTIFICIAL STRAWBERRY FLAVOR FV-3179 AS MANUFACTURED IN BETHLEHEM,
PENNSYLVANIA
26221 P *** PENDING FILING REVIEW ***
26222 A III 6/25/2012 AMPACET CORP 100664-E MOLD RELEASE PE MB AS MANUFACTURED IN BELGIUM, EUROPE
26223 A II 7/16/2012 ASYMCHEM LABORATORIES INC DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN TIANJIN, CHINA
26224 A II 12/17/2012 IROKO PHARMACEUTICALS LLC ZORVOLEX(TM) (DICLOFENAC) CAPSULES (ESUB) AS MANUFACTURED IN KANSAS CITY,
MO FOR IROKO PHARMACEUTICALS, LLC
26225 I II 8/16/2012 SANOFI PASTEUR INC PEGYLATED RECOMBINANT ANTI-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY
(KB001-A) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BERKSHIRE, UNITED
KINGDOM FOR SANOFI PASTEUR, INC
26226 A II 11/28/2012 TARO PHARMACEUTICAL INDUSTRIES LTD OXICONAZOLE NITRATE, MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL
26227 A III 7/10/2012 TOPPAN PRINTING CO LTD A PET/SILICONE LINER FOR TRANSDERMAL DRUG DELIVERY PATCHES AS
MANUFACTURED IN FUKUOKA, JAPAN
Page 787
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26228 A II 10/26/2012 UNIV TEXAS MD ANDERSON CANCER
CENTER
3'-DEOXY-3'-[F-18] FLUOROTHYMIDINE (18F-FLT) AS MANUFACTURED IN HOUSTON, TX
26229 A II 7/31/2012 APOGEPHA ARZNEIMITTEL GMBH P4 (ESUB) AS MANUFACTURED IN RADEBEUL, GERMANY AND DRESDEN, GERMANY FOR
APOGEPHA ARZNEIMITTEL GMBH
26230 A II 6/22/2012 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
EPROSARTAN MESYLATE AS MANUFACTURED IN ZHEJIANG, CHINA
26231 A IV 7/13/2012 ILE PHARMACEUTICAL MATERIALS CO LTD ETHYLCELLULOSE AQUEOUS DISPERSION (PROFESSIONAL) (NON-STERILE, BULK FORM)
AS MANUFACTURED IN TIANJIN , CHINA
26232 A IV 7/13/2012 ILE PHARMACEUTICAL MATERIALS CO LTD ETHYLCELLULOSE AQUEOUS DISPERSION (REGULAR) (NON-STERILE, BULK FORM) AS
MANUFACTURED IN TIANJIN , CHINA
26233 P *** PENDING FILING REVIEW ***
26234 A III 6/12/2012 ESS DEE ALUMINIUM LTD NON TOXIC FOOD CONTACT GRADE SOFT ALUMINIUM HOUSE FOIL (PLAIN & PRINTED)
AS MANUFACTURED IN NANI DAMAN (U.T.), INDIA
26235 A II 7/13/2012 APOTEX PHARMACHEM INDIA PVT LTD CABERGOLINE USP AS MANUFACTURED IN BANGALOR, INDIA
26236 A II 7/12/2012 PERRIGO API LTD ROTIGOTINE AS MANUFACTURED IN JINAN CITY, CHINA FOR CHEMAGIS LTD
26237 A III 7/19/2012 MITSUI CHEMICALS INC TAFMER A-0585X AS MANUFACTURED IN CHIBA, JAPAN
26238 A II 7/6/2012 QILU ANTIBIOTICS PHARMACEUTICAL CO
LTD
PACA INTERMEDIATE AS MANUFACTURED IN JINAN, CHINA
26239 A II 8/1/2012 AUROBINDO PHARMA LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (NON-STERILE DRUG SUBSTANCE)
(ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26240 A II 2/28/2012 SHANDONG LONGLIVE BIO TECHNOLOGY
CO LTD
XYLO-OLIGOSACCHARIDES AS MANUFACTURED IN YUCHENG CITY, P.R. OF CHINA
26241 A II 9/4/2012 ALEMBIC PHARMACEUTICALS LTD API DIV FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26242 A II 7/17/2012 LAURUS LABS PRIVATE LIMITED EFAVIRENZ USP (PROCESS-2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26243 A III 7/23/2012 KRISHNA FOILS PHARMACEUTICALS FOILS & FLEXIBLE PACKAGING PRODUCTS AS MANUFACTURED IN
AHMEDABAD INDIA
26244 P *** PENDING FILING REVIEW ***
26245 A II 7/23/2012 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
TRANS CHLOROATOVAQUONE AS MANUFACTURED IN GUJARAT, INDIA
26246 A II 7/31/2012 CTX LIFE SCIENCES PVT LTD PREGABALIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26247 A II 8/10/2012 HEBEI JIHENG GROUP PHARMACEUTICAL
CO LTD
ACETAMINOPHEN (ESUB) AS MANUFACTURED IN HENGSHUI CITY, CHINA
26248 A II 8/10/2012 HEBEI JIHENG GROUP PHARMACEUTICAL
CO LTD
ACETAMINOPHEN DC 90% (ESUB) AS MANUFACTURED IN HENGSHUI CITY, CHINA
26249 A II 7/26/2012 AARTI INDUSTRIES LTD LOTEPREDNOL ETABONATE AS MANUFACTURED IN MAHARASHTRA, INDIA
26250 A II 10/26/2012 RANBAXY LABORATORIES LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
26251 A II 9/10/2012 CADILA HEALTHCARE LTD SILODOSIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26252 A II 7/23/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD LETROZOLE AS MANUFACTURED IN SICHUAN, CHINA
26253 A II 7/10/2012 BEIJING GEYUAN TIANRUN BIO TECH CO
LTD
TRYPSIN AS MANUFACTURED IN BEIJING CITY
26254 A II 7/27/2012 SINTENOVO SA DE CV PALIPERIDONE AS MANUFACTURED IN ESTADO DE MEXICO
26255 A II 7/26/2012 INCELL CORP LLC ZTM: A1 AND ZTM: A2 DEFINED CULTURE MEDIA AS MANUFACTURED IN SAN ANTONIO,
TX
26256 A II 2/21/2013 SUN PHARMACEUTICAL INDUSTRIES LTD DECITABINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
Page 788
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26257 A II 8/12/2012 BRIGHTGENE BIO-MEDICAL TECHNOLOGY
CO., LTD.
2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4-(BENZYLOXY)-3-(BENZYLOXYMETHYL)-2-
METHYLENE CYCLOPENTYL]-6H-PURINE-6-ONE(ET1) (ESUB) AS MANUFACTURED IN
JIANGSU, CHINA
26258 A II 7/30/2012 HEBEI CHANGSHAN BIOCHEMICAL
PHARMACEUTICAL CO LTD
ENOXAPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA
26259 A III 7/27/2012 SHENG ZOU RUBBER AND PLASTICS
SUZHOU CO LTD
FORMULATION C25(C25B) RUBBER STOPPER AS MANUFACTURED IN SUZHOU CITY,
CHINA
26260 A III 7/27/2012 SHENG ZOU RUBBER AND PLASTICS
SUZHOU CO LTD
FORMULATION C31(C31B) AS MANUFACTURED IN SUZHOU CITY, CHINA
26261 A III 7/18/2012 NIPRO STERILE GLASS GERMANY AG STERILE TUBULAR GLASS VIALS AS MANUFACTURED IN MUNNERSTADT, GERMANY
26262 A II 7/25/2012 IOL CHEMICALS AND PHARMACEUTICALS
LTD
OMEPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA
26263 P *** PENDING FILING REVIEW ***
26264 I II 8/16/2012 SANOFI PASTEUR INC PEGYLATED RECOMBINANT ANIT-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY
(KB001-A) DRUG PRODUCT (ESUB) AS MANUFACTURED IN VITRY-SUR-SEINE CEDEX,
FRANCE AND ONTARIO, CANADA FOR SANOFI PASTEUR, INC.
26265 A III 8/1/2012 BRIGHTWOOD PHARMMED CONSUMABLE
BEIJING LTD
MULTILAYER TUBE (MF800) AS MANUFACTURED IN BEIJING, P.R. CHINA
26266 A II 7/31/2012 PHARMACEUTICAL WORKS POLPHARMA SA CARBAMAZEPINE AS MANUFACTURED IN GDANSKI, POLAND
26267 A II 7/30/2012 VUAB PHARMA AS OXALIPLATIN AS MANUFACTURED IN BRNO CEZCH REPUBLIC
26268 I II 7/20/2012 QILU ANTIBIOTICS LINYI PHARMACEUTICAL
CO LTD
WARFARIN SODIUM (NON-STERILE, API) AS MANUFACTURED IN LINYI COUNTY, P.R.
CHINA
26269 A II 7/30/2012 PROCOS SPA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN CAMERI, ITALY
26270 A II 7/21/2012 MSN PHARMACHEM PVT LTD LACOSAMIDE [ROUTE CODE-"LD"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26271 A II 8/1/2012 CHUNGHWA CHEMICAL SYNTHESIS AND
BIOTECH CO LTD
ETHYL ICOSAPENTATE AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN
26272 A II 8/1/2012 GALAXY SURFACTANTS LTD OCTINOXATE AS MANUFACTURED IN MAHARASHTRA, INDIA
26273 A III 7/23/2012 OH SUNG PLASTIC CO LTD CONTAINER & CLOSURE AS MANUFACTURED IN CHUNGCHEONGBUK-DO, SOUTH KOREA
26274 A III 8/1/2012 BEIJING AUSTAR HANSEN PACKAGING
TECHNOLOGY LTD
TWIST OFF PORT AS MANUFACTURED IN BEIJING CITY, CHINA
26275 A II 10/31/2012 LUPIN LTD FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26276 A II 7/30/2012 DEAD SEA BROMINE CO LTD MAGNESIUM OXIDE AS MANUFACTURED IN MOBILE POST ARAVA, ISRAEL
26277 A III 7/17/2012 OG CORP EMBOSSED PET FILM AS MANUFACTURED IN SHIGA-PREF., JAPAN
26278 A IV 7/27/2012 DINESH REMEDIES LTD HARD GELATIN CAPSULE SHELLS AS MANUFACTURED IN GUJARAT, INDIA
26279 A IV 7/31/2012 DOW CORNING CORP DOW CORNING SILASTIC BIOMEDICAL GRADE ETR ELASTOMERS AS MANUFACTURED IN
HEMLOCK, MICHIGAN
26280 A II 8/2/2012 SHANGHAI AJINOMOTO AMINO ACID CO LTD L-LYSINE MONOHYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, PEOPLE'S
REPUBLIC OF CHINA
26281 A II 5/24/2012 MAC CHEM PRODUCTS INDIA PVT LTD CYTARABINE USP AS MANUFACTURED IN BOISAR, INDIA
26282 A II 8/14/2012 RELIANCE LIFE SCIENCES PVT LTD BORTEZOMIB (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
26283 A III 8/1/2012 BULK PACKAGING LINERS PVT LTD PE FILM 40 FEET CONTAINER LINER AS MANUFACTURED IN KARNATAKA, INDIA
26284 A III 8/1/2012 BULK PACKING LINERS PVT LTD PE FILM 20 FEET CONTAINER LINER AS MANUFACTURED IN KARNATAKA, INDIA
26285 A III 7/18/2012 NOLATO JAYCARE LTD OVERCAP AS MANUFACTURED IN NEWCASTLE UPON TYNE ENGLAND
Page 789
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26286 A III 7/17/2012 NOLATO JAYCARE LTD 20ML MK2 POLYETHYLENE WHITE ROUND BOTTLE AS MANUFACTURED IN NEWCASTLE
UPON TYNE, ENGLAND
26287 A II 6/28/2012 JIANSHI YUANTONG BIOENGINEERING CO
LTD
RUTIN AS MANUFACTURED IN ENSHI CITY, HUBEI PROVIENCE P.R. CHINA
26288 A II 6/28/2012 HUNAN YUANTONG PHARMACEUTICAL CO
LTD
TROXERUTIN AS MANUFACTURED IN CHANGSHA CITY, HUNAN PROVINCE P.R. CHINA
26289 A II 9/7/2012 MSN ORGANICS PVT LTD FEBUXOSTAT [ROUTE CODE FUG] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
26290 P *** PENDING FILING REVIEW ***
26291 A II 7/26/2012 FARMABIOS S P A EXEMESTANE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI, ITALY
26292 P *** PENDING FILING REVIEW ***
26293 A III 8/9/2012 AMCOR FLEXIBLES GENT AF GENT EXTRUDED FILMS AND LAMINATES FOR PACKAGING AS MANUFACTURED IN
GENT, BELGIUM
26294 A II 3/8/2013 APICORE LLC MIGLUSTAT (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
26295 A II 8/9/2012 HEC PHARM USA INC LEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI
PROVINCE CHINA
26296 A III 8/9/2012 CONSOLIDATED BOTTLE CORP 120ML WHITE LDPE FLAT OVAL BOTTLE 20/410 AS MANUFACTURED IN CONCORD
ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION
26297 A II 8/2/2012 FIS FABBRICA ITALIANA SINTETICI SPA OLOPATADINE HCL AS MANUFACTURED IN VICENZA, ITALY
26298 A V 8/9/2012 VALDEPHARM STERILIZATION PROCESS VALIDATION FOR USE IN CEDEX, FRANCE
26299 A II 8/22/2012 CIPLA LTD ABACAVIR SULFATE USP (ESUB) AS MANUFACTURED IN PUNE MAHARASHTRA, INDIA
26300 A IV 7/24/2012 SEPPIC SA MONTANOX 80 PPI AS MANUFACTURED IN CASTRES CEDEX FRANCE
26301 A II 8/8/2012 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM SULFATE HEPTAHYDRATE AS MANUFACTURED IN NARUTO,
TOKUSHIMA JAPAN
26302 A II 8/8/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD URSODEOXYCHOLIC ACID AS MANUFACTURED IN PENGZHOU CITY,SICHUAN PROVINCE,
CHINA
26303 A II 8/13/2012 HETERO DRUGS LTD LOPINAVIR AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26304 A II 7/30/2012 ZHEJIANG APELOA JIAYUAN
PHARMACEUTICAL CO LTD
LAROPIPRANT AS MANUFACTURED IN DONGYANG CITY, ZHEJIANG PROVINCE, CHINA
26305 A II 8/3/2012 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
RILPIVIRINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA
26306 A III 8/8/2012 COLORTECH INC 11525-16 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN,
TENNESSEE AND ONTARIO, CANADA
26307 A II 8/14/2012 HETERO DRUGS LTD ENTECAVIR MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26308 A II 8/3/2012 CENTAUR PHARMACEUTICALS PRIVATE LTD TETRABENAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA
26309 A III 8/8/2012 KOREA ALUMINUM CO LTD CR(CHILD RESISTANT) FILM/PEEL & PUSH AS MANUFACTURED IN CHUNG-BUK, KOREA
26310 A II 8/8/2012 LIVZON GROUP FUZHOU FUXING
PHARMACEUTICAL CO LTD
VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN FUZHOU CITY, FUJIAN
PROVINCE, P.R. CHINA
26311 A II 9/4/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD TIGECYCLINE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
26312 A II 9/21/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN SULFATE PROCESS II (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
26313 A II 8/30/2012 AUROBINDO PHARMA LTD LACOSAMIDE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
Page 790
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26314 A II 8/24/2012 AUROBINDO PHARMA LTD VALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
26315 A IV 8/10/2012 VANDERBILT MINERALS LLC VEEGUM; NATIONAL FORMULARY GRADES" AS MANUFACTURED IN MURRAY, KY
26316 A II 10/9/2012 LUPIN LTD RUFINAMIDE (ESUB) AS MANUFACTURED IN GUJRAT, INDIA
26317 A II 8/27/2012 MACLEODS PHARMACEUTICALS LTD PREGABALIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26318 A II 9/22/2012 MACLEODS PHARMACEUTICALS LTD OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26319 A II 8/29/2012 UNIMARK REMEDIES LTD TENOFOVIR DISOPROXIL FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26320 A III 8/16/2012 VERSALIS SPA FLEXIRENE MR 50 A AS MANUFACTURED IN DUNKERQUE FRANCE FOR VERSALIS S.P.A.
26321 A II 7/26/2012 GEDEON RICHTER PLC CARIPRAZINE HYDROCHLORIDE AS MANUFACTURED IN DOROG, HUNGARY
26322 A II 8/17/2012 ACEBRIGHT INDA PHARMA PRIVATE LTD IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED IN
KARNATAKA, INDIA
26323 A II 10/15/2012 GLENMARK GENERICS LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26324 A II 9/6/2012 PAN DRUGS LTD GUAIFENESIN USP (NEW ROUTE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26325 P *** PENDING FILING REVIEW ***
26326 A II 8/21/2012 AMBIOPHARM INC GLUCAGON, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH
AUGUSTA, SC, AND SHANGHAI, CHINA
26327 A III 8/14/2012 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9697 TAN NONWOVEN POLYURETHANE TAPE AS MANUFACTURED IN
BROOKINGS, SD
26328 A II 8/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD DOCETAXEL AS MANUFACTURED IN PENGZHOU CITY, CHINA
26329 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENGZOU FORMULATION A03(A03B) RUBBER STOPPER AS MANUFACTURED IN HEFEI
CITY AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26330 A II 6/13/2012 HEMMO PHARMACEUTICALS PVT LTD OCTREOTIDE ACETATE AS MANUFACTURED IN DISTRICT THANE, INDIA
26331 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENG ZOU RUBBER STOPPER FORMULATION A18(A18B) AS MANUFACTURED IN HEFEI
CITY AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26332 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENG ZOU RUBBER STOPPER FORMULATION A04(A04B) AS MANUFACTURED IN HEFEI
CITY AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26333 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION A01 (A01B) RUBBER STOPPER AS MANUFACTURED IN HEFIEI
CITY, CHINA AND SUZHOU CITY CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26334 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION A41(A41B) RUBBER STOPPER AS MANUFACTURED IN HEFEI
CITY, CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26335 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION K02 (K02B) RUBBER STOPPER AS MANUFACTURED IN HEFEI
CITY, CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26336 A III 8/8/2012 SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION F22 (F22B) RUBBER STOPPER AS MANUFACTURED IN HEFEI
CITY, CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS
26337 A II 1/31/2013 CHEMWERTH INC ETHACRYNIC ACID NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA FOR CHEMWERTH, INC
26338 A II 3/1/2013 CHEMWERTH INC ETHACRYNATE SODIUM NON-STERILE, BULK DRUG (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA FOR CHEMWERTH, INC
26339 A II 11/29/2012 GLAXOSMITHKLINE LLC UMECLIDINIUM BROMIDE (ESUB) AS MANUFACTURED IN HERTFORDSHIRE, UK AND
JURONG, SINGAPORE FOR GLAXOSMITHKLINE
Page 791
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26340 A II 4/24/2013 IROKO PHARMACEUTICALS LLC TIFORBEX (INDOMETHACIN SUBMICRON PARTICLE) CAPSULES, 20 MG AND 40 MG (ESUB)
AS MANUFACTURED IN KANSAS CITY, MO FOR IROKO PHARMACEUTICALS, LLC
26341 A II 8/31/2012 EMCURE PHARMACEUTICALS LTD SULFAMETHOXAZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26342 A II 8/16/2012 ZHEJIANG KANGLE PHARMACEUTICAL CO
LTD
ACETAMINOPHEN DC90 AS MANUFACTURED IN WENZHOU CITY, CHINA
26343 A II 8/21/2012 NIVIKA CHEMO PHARMA PVT LTD NEBIVOLOL HCI AS MANUFACTURED IN GUJARAT, INDIA
26344 P *** PENDING FILING REVIEW ***
26345 A II 8/17/2012 APOTEX PHARMACHEM INDIA PVT LTD FESOTERODINE FUMARATE AS MANUFACTURED IN BANGALORE, INDIA
26346 A II 8/8/2012 QILU ANTIBIOTICS PHARMACEUTICAL CO
LTD
STERILE CEFUROXIME SODIUM PROCESS 1, BULK ANTIBIOTIC DRUG SUBSTANCE AS
MANUFACTURED IN SHANDONG CHINA
26347 A II 8/23/2012 NEULAND LABORATORIES LTD DAPIPRAZOLE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26348 A II 5/31/2013 KESHAVA ORGANICS PVT LTD PYRILAMINE MALEATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26349 A II 9/7/2012 ALEMBIC PHARMACEUTICALS LTD API DIV LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26350 A II 6/14/2013 CONCORD BIOTECH LTD EVEROLIMUS (ESUB) AS MANUFACTURED IN AHMEDABAD, INDIA
26351 A II 8/23/2012 MOREPEN LABORATORIES LTD ATORVASTATIN CALCIUM TRIHYDRATE AS MANUFACTURED IN HIMACHAL PRADESH,
INDIA
26352 A II 8/24/2012 SIEMENS MOLECULAR IMAGING INC SODIUM ACETATE C11 INJECTION AS MANUFACTURED IN OVERLAND PARK, KS
26353 A II 9/28/2012 HOSPIRA INC NT100H DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN THEBARTON, AUSTRALIA FOR
HOSPIRA, INC
26354 A II 8/22/2012 ACS DOBFAR SPA CEFPROZIL AS MANUFACTURED IN MILANO, ITALY
26355 A II 8/27/2012 MAC CHEM PRODUCTS INDIA PVT LTD BICALUTAMIDE USP AS MANUFACTURED IN BOISAR, INDIA
26356 A II 8/20/2012 PHARMAZELL VIZAG PRIVATE LTD CELECOXIB USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26357 A II 8/26/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD DESVENLAFAXINE BASE AS MANUFACTURED IN BHIND, INDIA AND BE'ER SHEVA, ISRAEL
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
26358 P *** PENDING FILING REVIEW ***
26359 A II 9/28/2012 CHROMO LABORATORIES INDIA PRIVATE
LTD
ZAFIRLUKAST PREMIX-50% W/W (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26360 A II 8/20/2012 BLOOMAGE FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-E 3.0) AS MANUFACTURED IN JINAN CITY, P.R. OF CHINA
26361 A II 8/28/2012 ALKERMES GAINESVILLE LLC N1752 EXTENDED RELEASE TABLETS, 18MG AS MANUFACTURED IN ATHLONE, IRELAND
FOR ALKERMES GAINESVILLE LLC
26362 A II 8/23/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD IMATINIB MESYLATE AS MANUFACTURED IN PENGZHOU CITY, CHINA
26363 P *** PENDING FILING REVIEW ***
26364 P *** PENDING FILING REVIEW ***
26365 A II 12/13/2013 TARO PHARMACEUTICAL INDUSTRIES LTD CLOCORTOLONE PIVALATE USP, MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA BAY,
ISRAEL
26366 A II 11/27/2012 MALLINCKRODT INC NORBUPRENORPHINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO
26367 A II 4/30/2014 CODY LABORATORIES INC MORPHINE BASE INTERMEDIATE (ESUB) AS MANUFACTURED IN CODY, WYOMING
26368 P *** PENDING FILING REVIEW ***
26369 A II 9/10/2012 AUROBINDO PHARMA LTD CEFIXIME USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
26370 A II 9/7/2012 MSN PHARMACHEM PVT LTD FESOTERODINE FUMARATE [ROUTE CODE FF] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26371 A IV 8/31/2012 WILD FLAVORS INC NATURAL PEPPERMINT FLAVOR WONF #FALT526 AS MANUFACTURED IN ERLANGER, KY
Page 792
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26372 A III 8/7/2012 SAMSUNG P AND S CO LTD CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO, SOUTH KOREA
26373 A V 8/3/2012 MICROTROL STERILISATION SERVICES PVT
LTD
ETHYLENE OXIDE STERILISATION
26374 A II 8/29/2012 SYN TECH CHEM AND PHARM CO LTD CROTAMITON AS MANUFACTURED IN TAINAN CITY, TAIWAN
26375 A II 9/5/2012 ASENCE PHARMA PRIVATE LTD AMPHOTERICIN B USP [PARENTERAL GRADE] AS MANUFACTURED IN VADODARA,
GUJARAT, INDIA FOR ASENCE PHARMA PRIVATE LIMITED
26376 A II 9/5/2012 MEDICHEM MANUFACTURING MALTA LTD MED-200850/M (LACOSAMIDE) AS MANUFACTURED IN HAL FAR BBG, MALTA
26377 A II 9/4/2012 JIANGSU HENGRUI MEDICINE CO LTD DEXMEDETOMIDINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS
MANUFACTURED IN LIANYUNGANG, JIANGSU, CHINA
26378 A II 7/22/2013 CHEMWERTH INC DIFLUPREDNATE (ESUB) AS MANUFACTURED IN TIANJIN, CHINA FOR CHEMWERTH INC
26379 A II 9/24/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD DESVENLAFAXINE FUMARATE (ESUB) AS MANUFACTURED IN BE'ER SHEVA, ISRAEL AND
BHIND (MADHYA PRADESH), INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
26380 A II 9/5/2012 AMBIOPHARM INC LEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH
AUGUST, SC, SHANGHAI, CHINA, AND HAIKOU CITY, CHINA FOR AMBIOPHARM, INC
26381 A II 9/27/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
26382 A II 9/5/2012 EUTICALS INC LACOSAMIDE AS MANUFACTURED IN SPRINGFIELD, MO
26383 A II 9/5/2012 MYLAN LABORATORIES LTD THIOTEPA USP AS MANUFACTURED IN MAHARASHTRA, INDIA
26384 A IV 9/5/2012 NIPPON SODA CO LTD HYDROXYPROPYL CELLULOSE OR HPC AS MANUFACTURED IN NIIGATA, JAPAN FOR
NIPPON SODA CO., LTD
26385 A II 9/29/2012 MSN LABORATORIES LTD RUFINAMIDE [ROUTE CODE RU] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26386 A II 11/6/2012 MSN LABORATORIES LTD UNIT II IMATINIB MESYLATE [ROUTE CODE-" IT"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26387 A II 9/14/2012 AUROBINDO PHARMA LTD PREGABALIN (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26388 A II 9/12/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN PENGZHOU CITY, CHINA
26389 A II 9/4/2012 FARMABIOS S P A STERILIZED MEDROXYPROGESTERONE ACETATE USP ( MICRONIZED) AS
MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY
26390 A III 9/7/2012 TERUMO CORP PLAJEX-READY-TO-FILL PLASTIC SYRINGES AS MANUFACTURED IN SHIZUOKA, JAPAN
26391 A II 9/5/2012 C S BIO CO TRIPTORELIN ACETATE, NON- STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN
MENLO PARK, CA
26392 A II 8/30/2012 RAKS PHARMA PVT LTD FESOTERODINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26393 P *** PENDING FILING REVIEW ***
26394 A IV 8/29/2012 UNGERER AND CO NATURAL CHERRY WONF FLAVOR FV-7380 AS MANUFACTURED IN BETHLEHEM,
PENNSYLVANIA
26395 A III 9/4/2012 ANDWIN SCIENTIFIC SEALSAFE SELF-SEALING DOSING ADAPTERS AS MANUFACTURED IN WOODLAND HILLS,
CALIFORNIA
26396 A II 9/10/2012 CHROMO LABORATORIES INDIA PRIVATE
LTD
REPAGLINIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26397 A II 9/6/2012 HETERO LABS LTD VALSARTAN (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26398 A II 9/7/2012 SUL OXIDOS INDUSTRIA E COMERCIO LTDA ZINC OXIDE AS MANUFACTURED IN SANTA CATARINA, BRAZIL
26399 A II 9/6/2012 MYLAN LABORATORIES LTD MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26400 A II 9/3/2012 EVONIK REXIM SAS L-PROLINE AS MANUFACTURED IN HAM, FRANCE
26401 A II 11/5/2012 DR REDDYS LABORATORIES LTD FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 793
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26402 A II 9/18/2012 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
NAPROXEN SODIUM GRANULE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R.
CHINA
26403 A II 9/3/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD CAPECITABINE AS MANUFACTURED IN SICHUAN, CHINA
26404 A II 9/19/2012 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
MYCOPHENOLIC ACID (ESUB) AS MANUFACTURED IN FUYANG CITY AND HANGZHOU
CITY, CHINA
26405 A II 11/23/2012 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
MYCOPHENOLATE MOFETIL (ESUB) AS MANUFACTURED IN FUYANG CITY, HANGZHOU
CITY AND ZHEJIANG, CHINA
26406 A II 12/16/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD PITAVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26407 A IV 8/29/2012 UNGERER AND CO ARTIFICIAL CARAMEL FLAVOR FV-7382 AS MANUFACTURED IN BETHLEHEM, PA
26408 P *** PENDING FILING REVIEW ***
26409 A III 8/22/2012 TIANJIN BOKELIN MEDICAL PACKAGING
TECHNOLOGY CO LTD
CODE NAME: G60T-004 AS MANUFACTURED IN TIANJIN, P.R. CHINA
26410 A III 9/7/2012 NYPRO INC TABLET APPLICATOR AS MANUFACTURED IN HOSUR, INDIA FOR NYPRO INC
26411 A II 8/20/2012 MANHATTAN ISOTOPE TECHNOLOGY LLC STRONTIUM-82 DRUG SUBSTANCE AS MANUFACTURED IN LUBBOCK, TEXAS
26412 A V 9/7/2012 DAIKYO SEIKO LTD RSV COMPONENT WASHING PROCESS AT HANDEA II BUILDING B IN OCHIGI, JAPAN
26413 A III 8/21/2012 VERSALIS SPA FLEXIRENE MT 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE FOR VERSALIS SPA
26414 A II 9/14/2012 NEULAND LABORATORIES LTD ROPINIROLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26415 A III 9/14/2012 SUMITOMO RUBBER INDUSTRIES LTD RUBBER CLOSURE AS MANUFACTURED IN HYOGO, JAPAN
26416 A II 9/14/2012 FERMION OY CARBIDOPA AS MANUFACTURED IN HANKO, FINLAND
26417 A II 10/1/2012 ALEMBIC PHARMACEUTICALS LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26418 A II 9/11/2012 DIVIS LABORATORIES LTD IRBESARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26419 A II 9/27/2012 UNIMARK REMEDIES LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26420 A II 9/6/2012 QILU TIANHE PHARMACEUTICAL CO LTD OLMESARTAN MEDOXOMIL (NON-STERILA API) AS MANUFACTURED IN JINAN, CHINA
26421 A III 7/13/2012 SHIJIAZHUANG ZHONGHUI LEECHDOM
PACKING CO LTD
HDPE BOTTLES FOR ORAL SOLID PREPARATION AS MANUFACTURED IN SHIJIAZHUANG
CITY, P.R. CHINA
26422 A II 9/11/2012 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
VALGANCICLOVIR HYDROCHLORIDE, CRYSTALLINE (DRUG SUBSTANCE) AS
MANUFACTURED IN XIANJU, P.R. CHINA
26423 A II 9/14/2012 HETERO DRUGS LTD SILODOSIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26424 A II 9/11/2012 ACEBRIGHT INDA PHARMA PRIVATE LTD IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED IN
KARNATAKA, INDIA
26425 I II 9/11/2012 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD SITAGLIPTIN PHOSPHATE ANHYDROUS AS MANUFACTURED IN DONGYANG CITY, CHINA
26426 A II 9/11/2012 UNIV MISSOURI RESEARCH REACTOR
CENTER
POTASSIUM MOLYBDATE (MO-99) FINAL INTERMEDIATE RADIOCHEMICAL AS
MANUFACTURED IN COLUMBIA, MISSOURI
26427 A II 9/17/2012 HETERO DRUGS LTD FESOTERODINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26428 A IV 9/18/2012 FONA INTERNATIONAL INC PRODUCT # 807.0439U MIXED BERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
26429 A II 9/17/2012 ST GOBAIN PERFORMANCE PLASTICS CORP BIO-SIL(R) 1450 AS MANUFACTURED IN TAUNTON, MA
26430 A II 9/18/2012 INDO PHYTO CHEMICALS PRIVATE LTD TESTOSTERONE USP AS MANUFACTURED IN UTTARAKHAND, INDIA
26431 A II 9/11/2012 LAURUS LABS PRIVATE LTD PEMETREXED DISODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26432 A III 9/17/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-LT-2.25 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 2.25 ML)
AS MANUFACTURED IN GUJARAT, INDIA
26433 A IV 9/12/2012 ANKIT PULPS & BOARDS PVT LTD (PHARMA
DIVISION)
MICROCRYSTALLINE CELLULOSE (USP) OF VARIOUS GRADES AS MANUFACTURED IN
MAHARASHTRA, INDIA
Page 794
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26434 A II 9/17/2012 ZHEJIANG XIANJU XIANMING
PHARMACEUTICAL CO LTD
PROGESTERONE, USP AS MANUFACTURED IN ZHEJIANG, CHINA
26435 A III 9/17/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-LT-5.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 5.0 ML) AS
MANUFACTURED IN GUJARAT, INDIA
26436 A III 9/17/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-LT-1.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 1.0 ML) AS
MANUFACTURED IN GUJARAT, INDIA
26437 A II 9/12/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD TRIMETAZIDINE DIHYDROCHLORIDE AS MANUFACTURED IN PENGZHOU CITY, CHINA
26438 A II 9/18/2012 CATALENT PHARMA SOLUTIONS LLC PALONOSETRON HC1 0.50 MG SOFTGELS (1.5 OVAL) AS MANUFACTURED IN SOMERSET,
NEW JERSEY
26439 A II 11/6/2012 UNIMARK REMEDIES LTD MONTELUKAST SODIUM USP (PROCESS-C) (ESUB) AS MANUFACTURED IN GUJARAT,
INDIA
26440 A II 10/31/2012 GLAND CHEMICALS PRIVATE LTD BORTEZOMIB (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
26441 A II 10/25/2012 GLAND CHEMICALS PRIVATE LTD ROCURONIUM BROMIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
26442 P *** PENDING FILING REVIEW ***
26443 A II 1/11/2013 CIPLA LTD RITONAVIR USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
26444 A II 11/1/2012 DR REDDYS LABORATORIES LTD PLERIXAFOR (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26445 A II 9/30/2013 SUN PHARMACEUTICAL INDUSTRIES LTD BUDESONIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26446 A II 9/26/2012 BIOPHORE INDIA PHARMACEUTICALS PVT.
LTD
ZILEUTON (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT. LTD.
26447 A II 9/26/2012 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
PHYTONADIONE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
BIOPHORE INDIA PHARMACEUTICALS PVT. LTD.
26448 A II 9/17/2012 MACFARLAN SMITH LTD A JOHNSON
MATTHEY CO
BUPRENORPHINE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM
26449 A II 9/7/2012 XIWANG PHARMACEUTICAL CO LTD DEXTROSE MONOHYDRATE AS MANUFACTURED IN BINZHOU CITY, P.R. CHINA
26450 A II 9/7/2012 XIWANG PHARMACEUTICAL CO LTD DEXTROSE ANHYDROUS AS MANUFACTURED IN BINZHOU CITY, P.R. CHINA
26451 A II 8/9/2012 HUNAN LIJIE BIOCHEMICAL CO LTD CHLOROXYLENOL AS MANUFACTURED IN CHANGSHA, CHINA
26452 A II 9/27/2012 AUROBINDO PHARMA LTD GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
26453 A II 9/20/2012 HYBIO PHARMACEUTICAL CO LTD EPTIFIBATIDE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
GUANGDONG, P.R. CHINA
26454 A II 8/30/2012 BEIJING GEYUAN TIANRUN BIO TECH CO
LTD
CHYMOTRYPSIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN BEIJING, CHINA
26455 A II 9/21/2012 ARGUS PHARMACEUTICALS LTD ORLISTAT AS MANUFACTURED IN CHANGSHA, CHINA
26456 A II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD GEFITINIB AS MANUFACTURED IN PENGZHOU CITY, CHINA
26457 A II 9/12/2012 WUXI KAILI PHARMACEUTICAL CO LTD EPTIFIBATIDE AS MANUFACTURED IN YIXING CITY, P.R. CHINA
26458 A II 9/18/2012 TIANJIN TIANYAO PHARMACEUTICALS CO
LTD
METHYLPREDNISOLONE, USP BULK AS MANUFACTURED IN TIANJIN, CHINA
26459 A II 9/21/2012 SANDOZ PRIVATE LTD SILODOSIN AS MANUFACTURED IN MAHARASHTRA, INDIA
26460 A II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD SORAFENIB TOSYLATE AS MANUFACTURED IN PENGZHOU, CHINA
26461 A II 9/20/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD VIDAGLIPTIN AS MANUFACTURED IN PENGZHOU, CHINA
26462 A II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD CABAZITAXEL AS MANUFACTURED IN PENGZHOU, CHINA
26463 A II 10/6/2012 EMCURE PHARMACEUTICALS LTD RITONAVIR USP (PROCESS II) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26464 A II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD SUNITINIB MALATE AS MANUFACTURED IN PENGZHOU, CHINA
26465 A II 9/20/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD LAPATINIB TOSYLATE AS MANUFACTURED IN PENGZHOU, CHINA
26466 A II 9/21/2012 TOMITA PHARMACEUTICAL CO LTD USP SODIUM SULFATE, ANHYDROUS AS MANUFACTURED IN TOKUSHIMA, JAPAN
Page 795
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26467 A II 9/21/2012 GLOCHEM INDUSTRIES LTD CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED AT VISAKHPATNAM DISTRICT
FACILITY IN ANDHRA PRADESH, INDIA
26468 A II 9/20/2012 ERREGIERRE SPA DEFERASIROX AS MANUFACTURED IN BERGAMO, ITALY
26469 A II 11/16/2012 NECTAR LIFESCIENCES LTD CEFTAZIDIME FOR INJECTION USP (STERILE BULK) (ESUB) AS MANUFACTURED IN
TEHSIL DERA BASSI, INDIA
26470 A II 9/17/2012 RESONANCE LABORATORIES PVT LTD GLYCOPYRROLATE AS MANUFACTURED IN BANGALORE, INDIA
26471 A III 9/21/2012 EQUISTAR CHEMICALS LP A
LYONDELLBASELL INDUSTRIES CO
PRO-FAX SR257M POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN
BAYPORT, TEXAS AND LAKE CHARLES, LOUISIANA
26472 A II 10/6/2012 CADILA HEALTHCARE LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26473 A II 9/21/2012 INCELL CORP LLC ZAPR RED BLOOD CELL LYSING BUFFER AS MANUFACTURED IN SAN ANTONIO, TEXAS
26474 A II 9/11/2012 JIAXING HENGJIE BIOPHARMACEUTICAL CO
LTD
CHONDROITIN SULFATE SODIUM (NON STERILE, BULK FORM) AS MANUFACTURED IN
JIAXING, P.R. CHINA
26475 A II 10/3/2012 DR REDDYS LABORATORIES LTD DUTASTERIDE (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26476 A II 9/21/2012 ZHEJIANG MEDICINE CO LTD XINCHANG
PHARMACEUTICAL FACTORY
BOSENTAN MONOHYDRATE AS MANUFACTURED IN XINCHANG, P.R. CHINA
26477 P *** PENDING FILING REVIEW ***
26478 P *** PENDING FILING REVIEW ***
26479 A II 5/2/2013 CHEMWERTH INC DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG (ESUB) AS
MANUFACTURED IN MAHARASHTRA, INDIA FOR CHEMWERTH, INC
26480 A II 10/12/2012 MSN ORGANICS PVT LTD (2R,3R)-3(3-METHOXY PHENYL)-N,N,2-TRIMETHYL PENTANE-1-AMINE HYDROCHLORIDE
[ROUTE CODE TPT4] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26481 A II 9/26/2012 INTERQUIM SA ROTIGOTINE AS MANUFACTURED IN BARCELONA, SPAIN
26482 A II 9/24/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD DIOSMIN AS MANUFACTURED IN PENGZHOU, CHINA
26483 A II 10/12/2012 AMOLI ORGANICS PVT LTD CLOTRIMAZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26484 A II 9/27/2012 SIGNA SA DE CV LACOSAMIDE AS MANUFACTURED IN TOLUCA MX, MEXICO
26485 P *** PENDING FILING REVIEW ***
26486 P *** PENDING FILING REVIEW ***
26487 A II 9/24/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD TROXERUTIN AS MANUFACTURED IN SICHUAN, CHINA
26488 A II 9/21/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD SOY ISOFLAVONES AS MANUFACTURED IN SICHUAN, CHINA
26489 A II 9/27/2012 AMBIOPHARM INC GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH
AUGUSTA, SC AND SHANGHAI, CHINA
26490 A II 9/27/2012 EUTICALS INC TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN
SPRINGFIELD, MISSOURI
26491 A II 9/27/2012 LEK PHARMACEUTICALS DD FESOTERODINE FUMARATE AS MANUFACTURED IN LJUBLJANA, SLOVENIA
26492 A II 9/27/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN PENGZHOU, CHINA
26493 A II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD TELBIVUDINE AS MANUFACTURED IN PENGZHOU, CHINA
26494 A II 9/25/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD DASATINIB AS MANUFACTURED IN PENGZHOU, CHINA
26495 A II 9/26/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN PENGZHOU, CHINA
26496 A III 9/25/2012 COIM USA INC NOVACOTE HS-8256 AS MANUFACTURED IN OFFANENGO, ITALY FOR COIM USA, INC
26497 A II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD NILOTINIB AS MANUFACTURED IN PENGZHOU, CHINA
26498 A II 9/28/2012 CHEMI SPA FESOTERODINE FUMARATE AS MANUFACTURED IN FROSINONE, ITALY AND BAHIA,
BRAZIL FOR CHEMI SPA
26499 A II 9/26/2012 MYLAN LABORATORIES LTD RIVASTIGMINE USP (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA
Page 796
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26500 A II 9/27/2012 SHASUN PHARMACEUTICALS LTD LEVETIRACETAM AS MANUFACTURED IN CUDDALORE, INDIA
26501 A II 9/27/2012 HETERO LABS LTD ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26502 A II 9/26/2012 SYN TECH CHEM AND PHARM CO LTD NAFTOPIDIL AS MANUFACTURED IN TAINAN, TAIWAN
26503 A II 10/13/2012 INTAS PHARMACEUTICALS LTD FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26504 A II 9/26/2012 SYN TECH CHEM AND PHARM CO LTD GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN, TAIWAN
26505 A II 10/30/2012 DSM SINOCHEM PHARMACEUTICALS
NETHERLANDS BV
AMPICILLIN TRIHYDRATE (PURICILLIN) (ESUB) AS MANUFACTURED IN PUNJAB, INDIA FOR
DSM SINOCHEM PHARMACEUTICALS NETHERLANDS B.V.
26506 A IV 10/1/2012 SHANXI GUANGSHENG MEDICINAL CAPSULE
CO LTD
VACANT CAPSULE AS MANUFACTURED IN SHANXI, CHINA
26507 A II 10/24/2012 WOCKHARDT LTD FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26508 A II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD HESPERIDIN AS MANUFACTURED IN PENGZHOU, CHINA
26509 A II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD RUTOSIDE TRIHYDRATE AS MANUFACTURED IN PENGZHOU, CHINA
26510 A III 9/28/2012 ROSELABS POLYMERS LTD. ROSEPOLY FILL LT 5 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 5
ML) AS MANUFACTURED IN GUJART, INDIA
26511 A III 9/28/2012 ROSELABS POLYMERS LTD. ROSEPOLY FILL LT 2.25 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE
2.25 ML) AS MANUFACTURED IN GUJARAT, INDIA
26512 A III 9/28/2012 ROSELABS POLYMERS LTD. ROSEPOLY FILL LT 1 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 1
ML) AS MANUFACTURED IN GUJART, INDIA
26513 A II 9/28/2012 MERCK AND CIE (R)-DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND
26514 A II 10/25/2012 ZHEJIANG EXCEL PHARMACEUTICAL CO LTD GABAPENTIN [API] (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
26515 A II 10/1/2012 HETERO LABS LTD MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26516 A III 10/1/2012 PROLAMINA CORP FLEXIBLE PACKAGING FOR PHARMACEUTICALS APPLICATIONS AS MANUFACTURED IN
WESTFIELD, MA, NEENAH, WI, AND TERREBONNE QC CANADA
26517 A II 9/22/2012 HEMMO PHARMACEUTICALS PVT LTD OXYTOCIN AS MANUFACTURED IN TURBHE, INDIA
26518 A II 6/21/2013 CADILA PHARMACEUTICALS LTD NATEGLINIDE FORM H (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26519 A II 10/23/2012 ALKEM LABORATORIES LTD TAPENTADOL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26520 A II 10/19/2012 INTAS PHARMACEUTICALS LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26521 A II 10/3/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 3 AS MANUFACTURED IN SANTA ANA, CALIFORNIA
26522 A II 10/3/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 2 (PRODUCT NUMBER 94121) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
26523 A II 10/3/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 1 (PRODUCT NUMBER 94119) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
26524 A II 10/3/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO GROWTH A (PRODUCT NUMBER 94120) AS MANUFACTURED IN SANTA
ANA, CALIFORNIA
26525 A II 10/4/2012 HETERO DRUGS LTD MOXIFLOXACIN HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26526 A III 10/2/2012 NAN YA PLASTICS CORP POLYVINYL CHLORIDE (PVC) PELLETS, MEDICAL GRADE AS MANUFACTURED IN
KAOHSIUNG CITY, TAIWAN (R.O.C.)
26527 A IV 10/4/2012 FONA INTERNATIONAL INC PRODUCT # 936.1368U ARTIFICIAL FLAVOR AS MANUFACTURED IN GENEVA, ILLINOIS
26528 A II 9/14/2012 CILAG AG METHYLNALTREXONE BROMIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND
AND MONTEGGIO, SWITZERLAND FOR CILAG AG
26529 A II 10/8/2012 ST PHARM CO LTD STAVUDINE DRUG SUBSTANCE AS MANUFACTURED IN GYEONGGI-DO, KOREA
26530 A II 9/28/2012 KURASHIKI TEXTILE MANUFACTURING CO
LTD
KURANBON AS MANUFACTURED IN OKAYAMA, JAPAN
Page 797
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26531 A II 3/12/2013 LUPIN LTD L-5-METHYLTETRAHYDROFOLATE CALCIUM (CRYSTALLINE) (ESUB) AS MANUFACTURED
IN MAHARASHTRA, INDIA
26532 A II 9/27/2012 AVANTI POLAR LIPIDS INC DODECYLPHOSPHOCHOLINE (DPC) AS MANUFACTURED IN ALABASTER, ALABAMA
26533 A II 9/30/2012 MEGAFINE PHARMA P LTD DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED
IN NASHIK, INDIA
26534 A II 10/10/2012 ITF CHEMICAL LTDA TEMOZOLOMIDE, USP AS MANUFACTURED IN BAHIA, BRAZIL
26535 A III 9/24/2012 AMERICHEM INC 58616-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OHIO
26536 A II 10/17/2012 AMOLI ORGANICS PVT LTD TELMISARTAN USP (ESUB) MANUFACTURED IN GUJARAT, INDIA
26537 A II 10/22/2012 WATSON PHARMA PRIVATE LTD OXYBUTYNIN CHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26538 A II 10/8/2012 DAEWOONG BIO INC STERILE MEROPENEM FOR INFECTION AS MANUFACTURED IN KYUNGGI-DO, KOREA
26539 A II 10/8/2012 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
VALACYCLOVIR HYDROCHLORIDE, ANHYDROUS FORM II AS MANUFACTURED IN XIANJU,
CHINA
26540 A II 10/11/2012 BIOCON LTD ROSUVASTATIN CALCIUM AS MANUFACTURED IN BANGALORE, INDIA
26541 A II 10/3/2012 PORTON FINE CHEMICALS LTD NICOTINE USP AS MANUFACTURED IN CHONGQING, CHINA
26542 A III 10/12/2012 POLINAS PLASTIK SANAYII VE TICARETI AS BIAXIALLY ORIENTED POLYPROPYLENE FILM NAMED AS 525 AS MANUFACTURED IN
MANISA, TURKEY
26543 A II 10/11/2012 GLOCHEM INDUSTRIES LTD PHTHALIMIDO AMLODIPINE (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
26544 A II 10/30/2012 JIANGXI TIANXIN PHARMACEUTICAL CO LTD PYRIDOXINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGXI, CHINA
26545 A II 11/14/2012 SAI LIFE SCIENCES LTD PARICALCITOL USP, NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN
KARNATAKA, INDIA
26546 A II 9/25/2012 PIRAMAL ENTERPRISES LTD VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26547 A II 12/6/2012 NATCO ORGANICS LTD BORTEZOMIB (ESUB) AS MANUFACTURED IN TAMILNADU, INDIA
26548 A II 10/5/2012 GULBRANDSEN TECHNOLOGIES INC ACHIEVE DA 1097 CP AS MANUFACTURED IN GUJARAT, INDIA
26549 A II 9/25/2012 WATERSTONE PHARMACEUTICALS HUBEI
CO LTD
FEBUXOSTAT AS MANUFACTURED IN HUBEI, CHINA
26550 A II 9/14/2012 MAC CHEM PRODUCTS INDIA PVT LTD LETROZOLE USP AS MANUFACTURED IN DISTRICT THANE, INDIA
26551 A II 9/18/2012 MELODY HEALTHCARE PVT LTD TIGECYCLINE AS MANUFACTURED IN MAHARASHTRA, INDIA
26552 A II 5/12/2014 LACAMAS LABORATORIES INC 1LZD-LINEZOLID, STEP 1 (1LZD) AS MANUFACTURED IN
PORTLAND, OREGON
26553 A IV 10/16/2012 UNGERER AND CO N/A CHERRY FLAVOR FV-7379 AS MANUFACTURED IN BETHLEHEM, PA
26554 A II 9/14/2012 MAC CHEM PRODUCTS INDIA PVT LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP AS MANUFACTURED IN DISTRICT
THANE, INDIA
26555 P *** PENDING FILING REVIEW ***
26556 A IV 10/16/2012 NEOPHARM CO LTD METHYL CAPROOYL TYROSINATE (CODE NAME: DEFENSAMIDE) AS MANUFACTURED IN
DAEJEON, KOREA
26557 A II 10/10/2012 AMPACET CORP 140891 ORANGE PP MB AS MANUFACTURED IN TERRE HAUTE, INDIANA
26558 A III 9/20/2012 INVISTA RESINS AND FIBERS GMBH POLYETHYLENE TEREPHTHALATE RESINS USED IN PACKAGING AS MANUFACTURED IN
GERSTHOFEN, GERMANY
26559 I II 10/15/2012 HUATAI BIOPHARM INC OMEGA-3-ACID ETHYL ESTERS (NON-STERILE, BULK FORM) AS MANUFACTURED IN
SICHUAN, P.R. CHINA
26560 A III 10/12/2012 BASF SE ULTRAFORM W2320 003 PRO TR UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
26561 A II 9/28/2012 LIANYUNGANG RUNZHONG
PHARMACEUTICAL CO LTD
PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN LIANYUNGANG, CHINA
Page 798
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26562 A II 10/24/2012 MELODY HEALTHCARE PVT LTD ALBUTEROL SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA
26563 A II 9/14/2012 MELODY HEALTHCARE PVT LTD TERBUTALINE SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA
26564 A III 10/10/2012 AMPACET CORP 181356 DARK BROWN PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
26565 A III 10/10/2012 AMPACET CORP 454458 PEARL RED PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
26566 A III 10/9/2012 AMPACET CORP 164364-K BLUE 364 AS MANUFACTURED IN RAYONG, THAILAND
26567 A III 10/10/2012 AMPACET CORP 131617 YELLOW PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
26568 A III 10/10/2012 AMPACET CORP 401198 HIGH HEAT PA PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
26569 A III 10/10/2012 HPT HOCHWERTIGE PHARMATECHNIK
GMBH CO KG
WHITE PE-BOTTLE 60ML AS MANUFACTURED IN NEUHAUS A. RWG., GERMANY
26570 A II 10/16/2012 KINOMEGA BIOPHARM INC. OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN DEYANG CITY, CHINA
26571 A II 11/29/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD ATORVASTATIN CALCIUM ( ESUB) AS MANUFACTURED IN UTTAR PRADESH, INDIA AND
MADHYA PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
26572 A II 10/25/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO GROWTH A ( PRODUCT NUMBER 91128) AS MANUFACTURED IN SANTA
ANA, CALIFORNIA
26573 A III 12/28/2012 KURARAY CO LTD HYBRAR-HYBRAR TM 7311F AND HYBRAR TM 7125F HYDROGENATED STYRENE-
ISOPRENE, BUTADIENE OR ISOPRENE/BUTADIENE BLOCK COPOLYMERS ( ESUB) AS
MANUFACTURED IN TOKYO, JAPAN
26574 A II 10/25/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 2 (PRODUCT NUMBER 91129) AS MANUFACTURED IN SANTA ANA
CALIFORNIA
26575 A II 10/25/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 1 (PRODUCT NUMBER 91127) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
26576 A II 10/22/2012 FUKUZYU PHARMACEUTICAL CO LTD NPS-005 AS MANUFACTURED IN TOYAMA, JAPAN
26577 A II 12/3/2012 CENTAUR PHARMACEUTICALS PRIVATE LTD MILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26578 A II 1/11/2013 RPG LIFE SCIENCES LTD MYCOPHENOLATE MOFETIL USP ( ESUB) AS MANUFACTURED IN MUMBAI, INDIA
26579 A II 10/24/2012 MELODY HEALTHCARE PVT LTD LEVOSALBUTAMOL SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA
26580 A II 10/26/2012 MAC CHEM PRODUCTS INDIA PVT LTD DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN DISTRICT THANE, INDIA
26581 A II 10/26/2012 MAC CHEM PRODUCTS INDIA PVT LTD ANASTROZOLE USP AS MANUFACTURED IN DISTRICT THANE, INDIA
26582 A II 2/11/2013 LUPIN LTD FEBUXOSTAT (MICRONIZED) ( ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26583 A IV 10/26/2012 FONA INTERNATIONAL INC 863.002 N-C LEMON-LIME FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA ILLINOIS
26584 A IV 10/26/2012 FONA INTERNATIONAL INC 884.628 N-C ORANGE FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, ILLINOIS
26585 A II 10/29/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 3 (PRODUCT NUMBER 99471) AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
26586 A II 10/23/2012 IOL CHEMICALS AND PHARMACEUTICALS
LTD
LANSOPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA
26587 A III 10/26/2012 WEST PHARMACEUTICAL SERVICES INC NOVAGUARD SA SAFETY SYSTEM AS MANUFACTURED IN VAUDREUIL, FRANCE
26588 A III 10/16/2012 UFLEX LTD PET + ALUMINIUM FOIL + POLY LAMINATES AS MANUFACTURED IN JAMMU, INDIA
26589 A II 12/30/2013 WISDOM PHARMCEUTICAL CO LTD MEFENAMIC ACID (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
26590 A III 10/16/2012 UFLEX LTD PAPER + POLY + ALUMINIUM FOIL + POLY LAMINATE AS MANUFACTURED IN JAMMU,
INDIA
Page 799
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26591 A III 10/16/2012 UFLEX LTD POLYAMIDE (NYLON) + ALUMINUM FOIL + PVC LAMINATE AS MANUFACTURED IN JAMMU,
INDIA
26592 A V 10/22/2012 NORTHSTAR MEDICAL RADIOISOTOPES LLC TECHNEGEN GENERATOR SYSTEM AS MANUFACTURED IN MADISON, WISCONSIN
26593 A II 12/23/2012 WISDOM PHARMCEUTICAL CO LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
26594 A II 12/17/2012 SYMPHONY PHARMA LIFESCIENCES
PRIVATE LTD
LACOSAMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26595 A II 10/30/2012 LAURUS LABS PRIVATE LTD DOCETAXEL ANHYDROUS, USP (PROCESS-2) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
26596 A II 11/5/2012 AMOLI ORGANICS PVT LTD ASCORBIC ACID USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26597 A II 11/2/2012 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
VALGANCICLOVIR HYDROCHLORIDE, AMORPHOUS (DRUG SUBSTANCE) AS
MANUFACTURED IN XIANJU, CHINA
26598 A III 10/26/2012 NEW AGE INDUSTRIES INC ADVANTAPURE SILICONE APST TUBING NI201 AS MANUFACTURED IN SHOUTHAMPTON,
PA
26599 A II 12/21/2012 GLENMARK GENERICS LTD RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA.
26600 P *** PENDING FILING REVIEW ***
26601 A II 11/7/2012 SIGMUND LINDNER GMBH SILIBEADS-CERAMIC BEADS TYPE ZY AS MANUFACTURED IN WARMENSTEINACH,
GERMANY
26602 A V 10/22/2012 EVONIK INDUSTRIES AG EUDRAGIT L/S AS MANUFACTURED IN DARMSTADT, GERMANY
26603 A II 11/12/2012 HETERO LABS LTD PLERIXAFOR AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26604 A II 12/21/2012 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
DAPTOMYCIN (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.
26605 A II 12/27/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DONEPEZIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE,
CHINA
26606 A II 12/30/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26607 A II 2/8/2013 RANBAXY LABORATORIES LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
26608 A III 11/12/2012 AMERICAN PACKAGING CORP PILL PACK OVERWRAP POUCH - PRINTED LAMINATION AS MANUFACTURED IN
COLUMBUS, WI, STORY CITY, IA AND ROCHESTER, NEW YORK
26609 A III 11/9/2012 SELENIS CANADA INC POLY(ETHYLENE TEREPHTHALATE) AS MANUFACTURED IN MONTREAL, QUEBEC
CANADA
26610 A II 11/2/2012 NANYANG PUKANG PHARMACEUTICAL CO
LTD
LINCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN NANYANG, CHINA
26611 A II 11/7/2012 DERIVADOS QUIMICOS SAU MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ALCANTARILLA, SPAIN
26612 A IV 11/8/2012 FINAR LTD ACETONITRILE HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA
26613 A III 11/9/2012 SANNER GMBH CONTAINER PACKAGING MATERIAL AS MANUFACTURED IN BENSHEIM, GERMANY,
KUNSHAN, CINA, AND BUDAPEST, HUNGARY
26614 A II 12/13/2012 SUN PHARMACEUTICAL INDUSTRIES LTD PEMETREXED DISODIUM HEPTAHYDRATE (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
26615 A II 12/20/2012 SUN PHARMACEUTICAL INDUSTRIES LTD DESVENLAFAXINE FUMARATE MONOHYDRATE (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
26616 A III 11/7/2012 AMPACET CORP 433548 TRANSP YELLOW SMC PP MB AS MANUFACTURED IN TERRE HAUTE, IN,
DERIDDER, LA, CATERSVILLE, GA AND HEATH, OH
26617 A III 10/30/2012 AMPACET CORP 466276 MYLAN BLUE SLIP PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,
LA, CARTERSVILLE, GA AND HEATH, OH
26618 A II 11/12/2012 MEIJI SEIKA PHARMA CO LTD ME1111 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO-KEN, JAPAN
Page 800
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26619 A II 10/29/2012 NTP RADIOISOTOPES SOC LTD FISSION IODINE-131 (PRODUCED FROM LOW ENRICHED URANIUM(LEU) NORMAL
PRODUCT AS MANUFACTURED IN PRETORIA, SOUTH AFRICA
26620 A II 1/9/2013 LUPIN LTD MILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26621 A III 11/16/2012 ASAHI KASEI CHEMICALS CORPORATION TUFTEC STYRENE BLOCK POLYMER WITH 1,3-BUTADIENE, HYDROGENATED AS
MANUFACTURED IN KANAGAWA, JAPAN
26622 A II 11/19/2012 BIAL PORTELA AND CA SA ESLICARBAZEPINE ACETATE AS MANUFACTURED IN VISP SWITZERLAND
26623 A II 12/31/2012 CATALENT PHARMA SOLUTIONS LLC SOFT GELATIN CAPSULE - OET-10275258 (ESUB) AS MANUFACTURED IN ST.
PETERSBURG, FL
26624 A II 11/19/2012 RAKS PHARMA PVT LTD MILNACIPRAN HYDROCHLORIDE, API AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26625 A IV 11/12/2012 UNGERER AND CO ARTIFICIAL BUBBLEGUM FLAVOR FS-12019 AS MANUFACTURED IN BETHLEHEM, PA
26626 A III 11/8/2012 PRETIUM PACKAGING PLASTIC PACKAGING MATERICALS AS MANUFACTURED IN PARIS, ILLINOIS
26627 A II 11/15/2012 IOL CHEMICALS AND PHARMACEUTICALS
LTD
LAMOTRIGINE AS MANUFACTURED IN PUNJAB, INDIA
26628 A III 11/12/2012 LOTTE CHEMICAL DAESAN PLANT POLYPROPYLENE (PP) - SB-520Y AS MANUFACTURED IN CHUNGNAM, KOREA
26629 A III 11/15/2012 LOTTE CHEMICAL YEOSU PLANT POLYPROPYLENE (PP) - SB-520Y, SB-550Y, SB-740D, SFC-750D AND SFO-130A
26630 A II 12/7/2012 APOTEX PHARMACHEM INC ADEFOVIR DIPIVOXIL AS MANUFACTURED IN ONTARIO, CANADA
26631 A II 1/22/2013 APOTEX PHARMACHEM INC ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ONTARIO, CANADA
26632 A II 3/5/2013 CADILA PHARMACEUTICALS LTD BOSENTAN MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26633 A III 4/9/2013 SHANGHAI BLOPAK CO LTD COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED
IN SHANGHAI, CHINA
26634 A IV 11/16/2012 BEIJING YINGMAO PHARMACEUTICAL CO
LTD
GASTRIC FILM COATING SYSTEM AS MANUFACTURED IN BEIJING, P.R. CHINA
26635 A II 9/27/2012 OLON SPA CLOFARABINE AS MANUFACTURED IN MILAN, ITALY
26636 A III 8/14/2012 THE PAPER PRODUCTS LTD PRIMARY PACKAGING MATERIAL, FLEXIBLE LAMINATES SPECIALIZED POUCHES, IN 1
PLY, 2PLY, 3PLY, 4PLY, 5PLY, 6PLY AND SHRINK SLEEVES AND LABELS FOR
PHARMACEUTICAL SOLID DOSAGE FORM AS MANUFACTURED IN UNION TERRITORY,
INDIA
26637 A II 12/10/2012 SIGNA SA DE CV EZETIMIBE AS MANUFACTURED IN TOLUCA, EDO MEXICO
26638 A V 11/20/2012 FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK
LTD
ABC5000 CONTRACT MANUFACTURING FACILITIES FOR THE MANUFACTURE OF
BIOTECHNOLOGY DRUG SUBSTANCES
26639 P *** PENDING FILING REVIEW ***
26640 A II 12/21/2012 SIGNA SA DE CV PROGESTERONE USP AS MANUFACTURED IN TOLUCA, ESTADO DE MEXICO
26641 A II 1/24/2013 INTERPHARMA PRAHA A S IOHEXOL DRUG SUBSTANCE, FOR ORAL PRODUCTS AS MANUFACTURED IN MODRANY,
CZECH REPUBLIC
26642 A II 11/26/2012 SHASUN PHARMACEUTICALS LTD MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN PUDUCHERRY, INDIA
26643 A II 11/26/2012 SANOCHEMIA PHARMAZEUTIKA AG GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN NEUFELD, AUSTRIA
26644 A III 11/22/2012 JAPAN VILENE CO LTD MEDICAL RELEASE LINER FILM, DL-01 AS MANUFACTURED IN SAITAMA, JAPAN
26645 A III 11/20/2012 AMPACET CORP 113375-K BLOMITE 75 AS MANUFACTURED IN RAYONG, THAILAND
26646 A III 11/26/2012 STELLA KUNSTSTOFFTECHNIK GMBH PLASTIC BOTTLE PP28, 50 ML, ACP 6031 D AN SECRO PP28 CHILDPROOF CLOSURE AS
MANUFACTURED IN KASTELLAUN AND ELTVILLE, GERMANY
26647 A II 11/8/2012 SEVEN STAR PHARMACEUTICAL CO LTD GADOPENTETATE DIMEGLUMINE AS MANUFACTURED IN NEW TAIPEI, TAIWAN
26648 A II 11/29/2012 AMOLI ORGANICS PVT LTD CHLORTHALIDONE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26649 A II 12/28/2012 FRESENIUS KABI ONCOLOGY LTD BUPIVACAINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA
26650 A II 12/25/2012 FRESENIUS KABI ONCOLOGY LTD ROPIVACAINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA
Page 801
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26651 A II 12/26/2012 YUNG SHIN PHARMACEUTICAL INDUSTRIAL
CO LTD
ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA
26652 A II 12/26/2012 YUNG SHIN PHARMACEUTICAL INDUSTRIAL
CO LTD
DOCETAXEL TRIHYDRATE (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA
26653 A IV 9/28/2012 SEPPIC SA SEPISPERSE LIQUID (AP, K, M, AS) AS MANUFACTURED IN CEDEX, FRANCE
26654 A II 11/19/2012 SHANGHAI ZIYUAN PHARMACEUTICAL CO
LTD
PHYTONADIONE USP, NON STERILE, BULK DRUG AS MANUFACTURED IN SHANGHAI,
CHINA
26655 N NOT AN ASSIGNED NUMBER
26656 A II 12/21/2012 FRESENIUS KABI ONCOLOGY LTD BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA
26657 A II 1/15/2013 MYLAN LABORATORIES LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26658 A II 11/15/2012 HUBEI HONGYUAN PHARMACEUTICAL CO
LTD
METRONIDAZOLE AS MANUFACTURED IN HUBEI PROVIENCE, CHINA
26659 A II 4/25/2012 QIDONG DONGYUE PHARMACEUTICAL CO
LTD
ACYCLOVIR AS MANUFACTURED IN JIANGSU CHINA
26660 A II 11/29/2012 FLUOROMED LP PERFLUORO(T-BUTYCYCLOHEXANE),96.0%(TRADE NAME APF-150M) AS MANUFACTURED
IN ROUND ROCK, TX
26661 A III 3/16/2013 RELIANCE INDUSTRIES LTD RELPET G5801 (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26662 A II 4/3/2013 LUPIN LTD DONEPEZIL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
26663 A IV 11/30/2012 SEIKAGAKU CORP SODIUM CHONDROITIN SULFATE (ND) AS MANUFACTURED IN KANAGAWA, JAPAN
26664 A II 3/11/2013 TARO PHARMACEUTICAL INDUSTRIES LTD DICHLORPHENAMIDE USP (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL
26665 A II 12/12/2012 CHEMPORT INC EPA960EE (ESUB) AS MANUFACTURED IN JEOLLANAM-DO, KOREA
26666 A III 11/29/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-SN-1 M1 (STERILE PRE FILLABLE GLASS SYRINGES 1.0 ML WITH STACKED
NEEDLE) AS MANUFACTURED IN GUJARAT, INDIA
26667 A II 8/12/2013 IPCA LABORATORIES LTD BISOPROLOL FUMARATE USP (PROCESS II) (ESUB) AS MANUFACTURED IN MADHYA
PRADESH, INDIA
26668 P *** PENDING FILING REVIEW ***
26669 P *** PENDING FILING REVIEW ***
26670 A III 11/29/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-LT-3.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 3.0 ML) AS
MANUFACTURED IN GUJARAT, INDIA
26671 A III 11/27/2012 EQUISTAR CHEMICALS LP A
LYONDELLBASELL INDUSTRIES CO
PRO-FAX SB891 POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN BAYPORT,
TX AND LAKE CHARLES, LA
26672 A II 11/20/2012 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
ATAZANAVIR SULFATE AS MANUFACTURED IN SHANGHAI, CHINA
26673 A II 1/23/2013 LUPIN LTD PREGABALIN (PROCESS-B) ( ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26674 A IV 11/29/2012 ABELEI INC PRODUCT # 160A30 NATURAL LEMON FLAVOR AS MANUFACTURED IN NORTH AURORA, IL
26675 A III 11/20/2012 HSIAO SUNG NON OXYGEN CHEMICAL CO
LTD
"O-BUSTER-E (ENZYME)' - OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG,
TAIWAN AND CHANG SU, CHINA
26676 A II 12/4/2012 BCN PEPTIDES SA NESIRITIDE AS MANUFACTURED IN BARCELONA, SPAIN
26677 A II 2/19/2013 CORLINE SYSTEMS AB CORLINE HEPARIN CONJUGATE (ESUB) AS MANUFACTURED IN UPPSALA, SWEDEN
26678 P *** PENDING FILING REVIEW ***
26679 P *** PENDING FILING REVIEW ***
26680 A II 1/7/2013 BIOIBERICA SA HEPARIN SODIUM (PROCESS P024900) AS MANUFACTURED IN BARCELONA, SPAIN
Page 802
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26681 A II 11/15/2012 LABORCHEMIE APOLDA GMBH D-PENICILLAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN THURINGIA,
GERMANY
26682 A II 12/6/2012 AMINO CHEMICALS LTD SAPROPTERIN DIHYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA
26683 A III 12/3/2012 UNIVERSAL MEDICAP LTD RUBBER CLOSURES AS MANUFACTURED IN GUJARAT, INDIA
26684 A II 12/4/2012 PIRAMAL ENTERPRISES LTD IRBESARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26685 A II 12/7/2012 NOSCH LABS PRIVATE LTD PANTOPRAZOLE SODIUM, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26686 A IV 4/8/2012 NITIKA PHARMACEUTICAL SPECIALITIES
PVT LTD
SODIUM STEARYL FUMARATE USP AS MANUFACTURED IN NAGPUR, INDIA
26687 A II 12/7/2012 HETERO LABS LTD IMATINIB MESYLATE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26688 A II 12/7/2012 HETERO LABS LTD PACLITAXEL, USP (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26689 A II 12/18/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26690 A II 12/19/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD VALSARTAN (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26691 P *** PENDING FILING REVIEW ***
26692 A II 1/18/2013 LABORCHEMIE APOLDA GMBH MENGLYTATE (ESUB) AS MANUFACTURED IN THURINGIA, GERMANY
26693 A II 12/21/2012 NATCO PHARMA LTD SORAFENIB TOSYLATE (SOT) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26694 A II 1/24/2013 INKE SA OLANZAPINE (ESUB) AS MANUFACTURED IN BARCELONA, SPAIN
26695 A II 10/19/2012 ZHEJIANG LANGHUA PHARMACEUTICAL CO
LTD
ZIDOVUDINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN TAIZHOU, P.R. CHINA
26696 A III 12/26/2012 FRESENIUS KABI DEUTSCHLAND GMBH FREEFLEX PACKAGING SYSTEM (POLYOLEFIN BAG) (ESUB) AS MANUFACTURED IN
HALDEN, NORWAY FOR FRESENIUS KABI DEUTSCHLAND GMBH
26697 A IV 12/11/2012 FINAR LTD MONOSODIUM GLYCIN CARBONATE HIGH PURITY GRADE (HP) AS MANUFACTURED IN
GUJARAT, INDIA
26698 A IV 12/11/2012 FINAR LTD CYCLOHEXANE HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA
26699 A II 1/9/2013 QILU ANTIBIOTICS PHARMACEUTICAL CO
LTD
CEFPROZIL AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
26700 A II 3/22/2013 DR REDDYS LABORATORIES LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26701 A II 12/31/2012 USV LTD LINEZOLID (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26702 A IV 12/11/2012 FINAR LTD N,N-DIMETHYL ACETAMIDE HIGH PURITY (HP) AS MANUFACTURED IN GUJARAT, INDIA
26703 A IV 12/11/2012 FINAR LTD BENZENE SULPHONIC ACID HIGH PURITY (HP) AS MANUFACTURED IN GUJARAT, INDIA
26704 A II 12/18/2012 NATCO PHARMA LTD BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TAMILNADU, INDIA
26705 A III 2/1/2013 KEYSTONE CAP CO THREADED METAL CLOSURES AS MANUFACTURED IN COLUMBIA, PA
26706 A II 12/24/2012 MACLEODS PHARMACEUTICALS LTD RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26707 A III 12/10/2012 LOPAREX BV RELEASE LINER BASED ON POLYESTER WITH 1 OR 2 SIDES SOLVENT LESS SILICONE
COATING AS MANUFACTURED IN APELDOORN, THE NETHERLANDS
26708 A II 12/11/2012 ITF CHEMICAL LTDA DECITABINE AS MANUFACTURED IN HUBEI, PR CHINA FOR ITF CHEMICAL LTDA
26709 A II 1/15/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275260] (ESUB) AS MANUFACTURED IN PETERSBURG, FL
26710 A IV 12/11/2012 MK SILICONE PRODUCTS PVT LTD SILICONE TRANSPARENT TUBING AS MANUFACTURED IN MUMBAI, INDIA
26711 A II 12/3/2012 BASF SE L-MENTHOL AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY
26712 A II 12/6/2012 ZHEJIANG LANGHUA PHARMACEUTICAL CO
LTD
LEVOFLOXACIN AS MANUFACTURED IN TAIZHOU, P.R. CHINA
Page 803
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26713 A IV 11/8/2012 MB SUGARS AND PHARMACEUTICALS LTD CONFECTIONERS SUGAR (USP) AS MANUFACTURED IN MAHARASHTRA, INDIA
26714 A II 2/28/2013 UNIV TEXAS MD ANDERSON CANCER
CENTER
F 18 SODIUM FLUOROACETATE (18F-FACE) INJECTION (ESUB) AS MANUFACTURED IN
HOUSTON, TX
26715 A II 7/19/2013 HELSINN ADVANCED SYNTHESIS SA NETUPITANT (ESUB) AS MANUFACTURED IN BIASCA, SWITZERLAND
26716 A II 12/11/2012 BCN PEPTIDES SA LEUPROLIDE (LEUPRORELIN) AS MANUFACTURED IN BARCELONA, SPAIN
26717 P *** PENDING FILING REVIEW ***
26718 A II 3/4/2013 JUBILANT LIFE SCIENCES LTD FEXOFENADINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN NANJANGUD, INDIA
26719 A II 3/7/2013 JUBILANT LIFE SCIENCES LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN NANJANGUD, INDIA
26720 A II 3/4/2013 JUBILANT LIFE SCIENCES LTD BUPROPION HYDROBROMIDE (ESUB) AS MANUFACTURED IN NANJANGUD INDIA
26721 A II 2/24/2014 LABORCHEMIE APOLDA GMBH BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN THURINGIA, GERMANY
26722 A II 12/29/2012 SUN PHARMACEUTICAL INDUSTRIES LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26723 A II 1/4/2013 SUN PHARMACEUTICAL INDUSTRIES LTD BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26724 A II 11/28/2012 SIGMUND LINDNER GMBH SILIBEADS - CERAMIC BEADS TYPE ZY PREMIUM AS MANUFACTURED IN
WARMENSTEINACH, GERMANY
26725 A II 11/28/2012 STERLING SPA ABIRATERONE ACETATE AS MANUFACTURED IN PERUGIA, ITALY
26726 A II 1/24/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD METHYLDOPA (ESUB) AS MANUFACTURED IN HANGZHOU, P. R. CHINA FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
26727 A II 11/5/2012 SHAANXI HUIFENG PHARMACEUTICAL LTD RUTOSIDE TRIHYDRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN XIANYANG,
CHINA
26728 A II 12/14/2012 CHINOIN PHARMACEUTICAL AND CHEMICAL
WORKS PRIVATE CO LTD
LATANOPROST AS MANUFACTURED IN BUDAPEST, HUNGARY
26729 A IV 12/12/2012 JRS PHARMA LP PROSOLV ODT (CO-PROCESSED EXCIPIENT FOR ORAL DISSOLVING TABLET) AS
MANUFACTURED IN BETHLEHEM, PENNSYLVANIA FOR JRS PHARMA LP
26730 A III 12/12/2012 KUNSHAN WISEPAC DESICCANT CO LTD DESICCANT (SILICA GEL WITH TYVEK 1059B AS PACKAGING MATERIALS) AS
MANUFACTURED IN JIANGSU, CHINA
26731 A III 12/18/2012 AMERICAN PACKAGING CORP INHALATION DRUG OVERWRAP AS MANUFACTURED IN ROCHESTER, NY, STORY CITY, IA
AND COLUMBUS, WI
26732 A III 12/6/2012 SANNER GMBH CLOSURES AS MANUFACTURED IN BENSHEIM, GERMANY, KUNSHAN, CHINA AND
BUDAPEST, HUNGARY
26733 A IV 12/12/2012 HANGZHOU GAOCHENG BIOTECH AND
HEALTH CO LTD
MICROCRYSTALLINE CELLULOSE SPHERES, USP AS MANUFACTURED IN HANGZHOU,
CHINA
26734 A II 1/7/2013 ZHEJIANG CHIRAL MEDICINE CHEMICALS CO
LTD
CRUDE CARBIDOPA AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
26735 A II 1/9/2013 PROVEPHARM SAS METHYLENE BLUE (ESUB) AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE
26736 A III 12/17/2012 REXAM HEALTHCARE LE TREPORT SAS SP3 PUMPS FOR SPRAY DRUG PRODUCTS AS MANUFACTURED IN TREPORT, FRANCE
26737 A IV 12/10/2012 HANGZHOU GAOCHENG BIOTECH & HEALTH
CO. LTD.
SUGAR SPHERES, USP AS MANUFACTURED IN HANGZHOU, CHINA
26738 A II 12/17/2012 HANGZHOU HUADONG MEDICINE GROUP
KANGRUN PHARMACEUTICAL CO LTD
EVEROLIMUS AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
26739 A II 1/11/2013 WISDOM PHARMCEUTICAL CO LTD LAMIVUDINE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
26740 A II 2/1/2013 WISDOM PHARMCEUTICAL CO LTD FASUDIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
26741 A II 12/31/2012 APOTEX PHARMACHEM INDIA PVT LTD FEBUXOSTAT AS MANUFACTURED IN BANGALORE, INDIA
26742 A II 12/20/2012 LOPAREX LLC FLUORINE SILICONE COATED RELEASE LINERS AS MANUFACTURED IN IOWA CITY, IA
Page 804
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26743 A II 2/26/2013 WOCKHARDT BIO AG ARIPIPRAZOLE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR WOCKHARDT
BIO AG
26744 A IV 12/18/2012 BEIJING YINGMAO PHARMACEUTICAL CO
LTD
ENTERIC FILM COATING SYSTEM AS MANUFACTURED IN BEIJING, P.R. CHINA
26745 A II 12/19/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD TAUROURSODEOXYCHOLIC ACID AS MANUFACTURED IN PENGZHOU CITY, CHINA
26746 A II 12/20/2012 HETERO DRUGS LTD ELTROMBOPAG OLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26747 A II 12/20/2012 HETERO DRUGS LTD NABUMETONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26748 A III 12/17/2012 TEKNOR COLOR CO 84,060CP YELLOW 2% AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX
26749 A III 12/17/2012 AMPACET CORP 7010575 SLIP PE MB AS MANUFACTURED IN CATERSVILLE, GA
26750 A III 12/17/2012 AMPACET CORP 103233 TACKIFER PE MB AS MANUFACTURED IN CATERSVILLE, GA
26751 A II 12/20/2012 HETERO LABS LTD ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26752 A II 12/21/2012 HETERO DRUGS LTD BUPROPION HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26753 A II 12/21/2012 HETERO LABS LTD CYCLOPHOSPHAMIDE MONOHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
26754 A III 10/16/2012 UFLEX LTD PET + POLY + ALUMINIUM FOIL + POLY LAMINATE AS MANUFACTURED IN JAMMU, INDIA
26755 A II 12/18/2012 NORAC PHARMA ETO-10100 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CALIFORNIA
26756 A II 1/30/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
(3S, 4R) ALCOHOL COMPOUND (CHEMICAL NAME: (3S, 4R)-4-(4-FLUOROPHENYL)-3-
HYDROXYMETHYL-1-METHYLPIPERIDINE) AS MANUFACTURED IN ZHEJIANG, CHINA FOR
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
26757 A II 12/21/2012 POLYPEPTIDE LABORATORIES FRANCE EPTIFIBATIDE AS MANUFACTURED IN STRASBOURG, FRANCE
26758 A II 12/28/2012 ROVI CONTRACT MANUFACTURING SL STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE AS MANUFACTURED IN
MADRID, SPAIN AND BARCELONA SPAIN FOR ROVI CONTRACT MANUFACTURING SL
26759 A III 12/25/2012 ROSELABS POLYMERS LTD STERILE DISPOSABLE PREFILLABLE POLYMER SYRINGES 1.0 ML WITH STACKED
NEEDLE AS MANUFACTURED IN GUJARAT, INDIA
26760 A III 12/25/2012 ROSELABS POLYMERS LTD STERILE DISPOSABLE PREFILLABLE POLYMER SYRINGES 2.25 ML WITH STACKED
NEEDLE AS MANUFACTURED IN GUJARAT, INDIA
26761 A II 12/20/2012 SOUVIN PHARMACEUTICALS I PVT LTD TOLNAFTATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
26762 A II 12/26/2012 SHASUN PHARMACEUTICALS LTD DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE, USP AS MANUFACTURED IN
TAMIL NADU, INDIA
26763 A II 12/28/2012 HEC PHARM USA INC OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU CITY,
P.R. CHINA FOR HEC PHARM USA INC
26764 A II 12/27/2012 SCINOPHARM TAIWAN LTD ROFLUMILAST AS MANUFACTURED IN JIANGSU, CHINA FOR SCINOPHARM TAIWAN LTD
26765 A II 12/27/2012 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
ROCURONIUM BROMIDE USP NON-STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN XIANJU, CHINA
26766 A II 12/20/2012 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
LUMEFANTRINE AS MANUFACTURED IN SHANGHAI, CHINA
26767 A II 12/7/2012 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
TENOFOVIR AS MANUFACTURED IN SHANGHAI, CHINA
26768 A II 8/24/2012 ZHEJIANG JIANFENG HAIZHOU
PHARMACEUTICAL CO LTD
METHOCARBAMOL AS MANUFACTURED IN ZHEJIANG, CHINA
Page 805
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26769 A II 12/28/2012 HEC PHARM USA INC PRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN GUANGDONG PROVINCE, CHINA FOR HEC PHARM USA INC.
26770 A II 12/28/2012 SCINOPHARM TAIWAN LTD LEUPROLIDE MESYLATE AS MANUFACTURED IN TAIWAN, R.O. CHINA
26771 A II 12/20/2012 SOUVIN PHARMACEUTICAL I PVT LTD MEFENAMIC ACID BP AS MANUFACTURED IN MAHARASHTRA, INDIA
26772 A II 12/20/2012 SOUVIN PHARMACEUTICAL I PVT LTD DIPHENHYDRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA,
INDIA
26773 A V 12/31/2012 EVONIK INDUSTRIES AG WERK ROHEM EUDRAGIT RL/RS
26774 A II 12/19/2012 LAURUS LABS PRIVATE LTD BORTEZOMIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26775 A IV 12/3/2012 HEUBACH COLOUR PVT LTD DRIED ALUMINIUM HYDROXIDE GEL USP AS MANUFACTURED IN GUJARAT, INDIA
26776 A II 12/27/2012 CHEMO IBERICA SA ALISKIREN HEMIFUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
CHEMO IBERICA SA
26777 A II 12/26/2012 MYLAN LABORATORIES LTD SILDENAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26778 A II 1/7/2013 ZHEJIANG MEDICINE CO LTD XINCHANG
PHARMACEUTICAL FACTORY
DAPTOMYCIN API AS MANUFACTURED IN ZHEJIANG, CHINA
26779 A II 12/24/2012 CHONGQING PHARMACEUTICAL RESEARCH
INSTITUTE CO LTD
ABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN
CHONGQING, PEOPLE'S REPUBLIC OF CHINA
26780 A IV 1/2/2013 HUBEI GREENHOME FINE CHEMICAL CO LTD BENZYL ALCOHOL AS MANUFACTURED IN HUBEI PROVINCE, CHINA
26781 A II 4/9/2013 LUPIN LTD ROSUVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN MANDIDEEP, INDIA
26782 A II 4/18/2013 LUPIN LTD OLMESARTAN MEDOXOMIL USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26783 A II 3/11/2013 GLENMARK GENERICS LTD SITAGLIPTIN PHOSPHATE MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT
STATE, INDIA
26784 A II 2/5/2013 MSN LABORATORIES LTD UNIT II PALONOSETRON HYDROCHLORIDE [ROUTE CODE PI] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
26785 A II 3/8/2013 MSN ORGANICS PVT LTD ASENAPINE MALEATE [ROUTE CODE "AN"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26786 A II 2/8/2013 MSN ORGANICS PVT LTD TADALAFIL [ROUTE CODE - "TP"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26787 A II 1/3/2013 PHARMACEUTICAL WORKS POLPHARMA SA ACYCLOVIR AS MANUFACTURED IN GDANSKI, POLAND
26788 A III 1/1/2013 MULTIPLAST POLYMER PVT LTD PLASTIC HDPE BOTTLES FOR PHARMACEUTICAL USE AS MANUFACTURED IN
MAHARASHTRA, INDIA
26789 A II 1/4/2013 NOSCH LABS PRIVATE LTD DULOXETINE HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26790 A III 1/4/2013 HSIAO SUNG NON OXYGEN CHEMICAL CO
LTD
DESICCANT AS MANUFACTURED IN TAICHUNG CITY, TAIWAN AND JIANG SU PROV.,
CHINA FOR HSIAO SUNG NON OXYGEN CHEMICAL CO LTD
26791 A II 12/30/2012 YAOPHARMA CO LTD CLINDAMYCIN PALMITATE HC1 (NON-STERILE BULK DRUG SUBSTANCE) AS
MANUFACTURED IN CHONGQING, PEOPLES REPUBLIC OF CHINA
26792 A II 1/17/2013 INTAS PHARMACEUTICALS LTD PACLITAXEL USP (SEMI-SYNTHETIC) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26793 A II 1/15/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGEL CAPSULE [OET-10275263] (ESUB) AS MANUFACTURED IN ST. PETERSBURG,
FLORDIA
26794 A II 12/27/2012 SUVEN LIFE SCIENCES LTD DOXOFYLLINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26795 A II 2/6/2013 SUN PHARMACEUTICAL INDUSTRIES LTD EPTIFIBATIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26796 A II 3/14/2013 SUN PHARMACEUTICAL INDUSTRIES LTD OMEPRAZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26797 A II 1/7/2013 STERLING SPA DESOXYCORTICOSTERONE PIVALATE AS MANUFACTURED IN PERUGIA, ITALY
26798 A IV 1/8/2013 SEPPIC SA SEPICOAT AS MANUFACTURED IN CASTRES CEDEX, FRANCE
26799 A II 1/7/2013 LEE PHARMA LTD LANSOPRAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 806
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26800 A II 12/13/2012 CAMBREX CHARLES CITY INC SUFENTANIL CITRATE AS MANUFACTURED IN CHARLES CITY, IOWA
26801 A II 1/4/2013 ZHEJIANG ZONE BANNER CHEMICAL CO LTD 3-CHLORO-IMINODIBENZYL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26802 A II 1/5/2013 HEC PHARM USA INC IRBESARTAN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI
PROVINCE, P.R. CHINA FOR HEC PHARM USA INC.
26803 A II 1/9/2013 HUBEI GEDIAN HUMANWELL
PHARMACEUTICAL CO LTD
DUTASTERIDE AS MANUFACTURED IN HUBEI, CHINA
26804 A II 1/31/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
METOPROLOL SUCCINATE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
26805 A II 12/18/2012 FRESENIUS KABI ANTI INFECTIVES SRL CLOXACILLIN BENZATHINE STERILE AS MANUFACTURED IN MILAN, ITALY
26806 A II 8/6/2012 FARMHISPANIA SA METFORMIN HYDROCHLORIDE / 0.75% COLLOIDAL SILICON DIOXIDE BLEND AS
MANUFACTURED IN MONTMELO, SPAIN
26807 A II 2/20/2013 GLENMARK GENERICS LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
26808 A II 2/18/2013 CENTAUR PHARMACEUTICALS PRIVATE LTD TRANYLCYPROMINE SULFATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26809 A IV 1/16/2013 JC BIOLOGY TECHNOLOGY CO LTD UNFILLED HARD SHELL HYPROMELLOSE CAPSULES AS MANUFACTURED IN SHANXI
PROVINCE, CHINA
26810 A III 1/10/2013 SAGAR RUBBER PRODUCTS PVT LTD RUBBER GASKET FOR PRE-FILLED SYRINGES (RFS/RFU) AS MANUFACTURED IN
GUJARAT, INDIA
26811 A II 1/15/2013 HEC PHARM USA INC FELODIPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI
PROVINCE, P.R. CHINA FOR HEC PHARM USA INC
26812 A III 1/3/2013 CHARTER NEX FILMS INC CHARTER NEX FILMS GRADE C8082 AS MANUFACTURED IN TURNERS FALLS, MA AND
MILTON, WI
26813 A II 2/5/2013 IND SWIFT LABORATORIES LTD COLESEVELAM HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
26814 A II 2/15/2013 EMCURE PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26815 A II 2/1/2013 EMCURE PHARMACEUTICALS LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26816 A II 9/5/2013 ACIC FINE CHEMICALS INC CYSTEAMINE BITARTRATE (ESUB) AS MANUFACTURED IN TOLUCA, MEXICO FOR ACIC
FINE CHEMICALS INC.
26817 A III 1/18/2013 AVERY DENNISON S-2060N ADHESIVE AS MANUFACTURED IN HARYANA, INDIA FOR AVERY DENNISON
26818 A II 1/6/2013 LIANYUNGANG GUIKE PHARMACEUTICAL
CO., LTD.
CAPECITABINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN JIANGSU, CHINA
26819 A II 2/8/2013 CHUNGHWA CHEMICAL SYNTHESIS AND
BIOTECH CO LTD
EVEROLIMUS PRE-MIX (ESUB) AS MANUFACTURED IN
NEW TAIPEI CITY, TAIWAN
26820 A II 1/31/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MEROPENEM STERILE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26821 A III 1/17/2013 SHREE RAMA MULTI TECH LTD LAMI TUBES AS MANUFACTURED IN GUJARAT, INDIA
26822 A III 1/18/2013 YMC CO LTD YMC- TRIART SERIES AS MANUFACTURED IN ISHIKAWA, JAPAN
26823 A III 1/18/2013 BORMIOLI ROCCO SPA BU PLASTICA PET BOTTLE 300 ML AS MANUFACTURED IN CASTELGUELFO PR, ITALY; RIVANAZZANO
PV, ITALY AND SAINT SULPICE, FRANCE
26824 A II 8/23/2013 APOTEX PHARMACHEM INC DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ONTARIO,CANADA
26825 A II 3/30/2013 SUN PHARMACEUTICAL INDUSTRIES LTD TEMSIROLIMUS (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26826 A II 3/19/2013 SUN PHARMACEUTICAL INDUSTRIES LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26827 A III 12/20/2012 LOPAREX LLC FLUORINE SILICONE COATED RELEASE LINERS PRODUCT TYPE ONE AS
MANUFACTURED IN IOWA CITY, IA
26828 P *** PENDING FILING REVIEW ***
26829 A II 2/13/2013 APOTEX PHARMACHEM INDIA PVT LTD ESZOPICLONE AS MANUFACTURED IN BANGALORE, INDIA
Page 807
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26830 A II 1/31/2013 FORTEQ NIDAU AG MIRENA INSERTER PROJECT AS MANUFACTURED IN NIDAU, SWITZERLAND
26831 A III 1/18/2013 EQUISTAR CHEMICALS LP A
LYONDELLBASELL INDUSTRIES CO
PRO-FAX RP512H POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN
PASADENA, TX AND WEST LAKE, LA
26832 A II 2/20/2013 POLYPEPTIDE LABORATORIES SWEDEN AB LEUPROLIDE ACETATE (ESUB) AS MANUFACTURED IN THANE, INDIA FOR POLYPEPTIDE
LABORATORIES (SWEDEN) AB
26833 A II 2/27/2013 ALEMBIC PHARMACEUTICALS LTD API DIV DEFERASIROX (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26834 A III 1/15/2013 JOBAN GLASS CO., LTD TUBULAR VIALS FOR PHARMACEUTICAL USE AS MANUFACTURED IN FUKUSHIMA
PREFECTURE, JAPAN
26835 A II 3/15/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD FULVESTRANT (ESUB) AS MANUFACTURED IN MILAN, ITALY FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
26836 A III 1/21/2013 COLORS FOR PLASTICS INC THERMOPLASTICS RESIN R34151 RED/1797C COLORANT MASTERBATCH AS
MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS AND SPARTANBURG, SC
26837 A II 1/14/2013 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
PRAZIQUANTEL AS MANUFACTURED IN SHANGHAI, CHINA
26838 P *** PENDING FILING REVIEW ***
26839 A IV 1/17/2013 TAKASAGO INTERNATIONAL CORP MICRON INTENSATES NATURAL AND ARTIFICIAL COOL SPEARMINT FLAVOR TAK-122461
AS MANUFACTURED IN TETERBORO, NJ
26840 A IV 1/17/2013 TAKASAGO INTERNATIONAL CORP TAK-122311 MICRON INTENSATES ARTIFICAL ICE FLAVOR AS MANUFACTURED IN
TETERBORO, NJ
26841 A II 3/29/2013 TARO PHARMACEUTICAL INDUSTRIES LTD DESOXIMETASONE USP, MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL
26842 A IV 1/17/2013 TAKASAGO INTERNATIONAL CORP TAK-122134 MICRON INTENSATES NATURAL AND ATIFICIAL PEPPERMINT EXTRA FLAVOR
AS MANUFACTURED IN TETERBORO, NJ
26843 A II 1/22/2013 HEC PHARM USA INC SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN
GUANGDONG PROVINCE, P.R. CHINA
26844 A II 1/18/2013 SHANDONG XINHUA PHARMACEUTICAL CO
LTD
ASPIRIN REFINED AS MANUFACTURED IN SHANDONG, P.R. CHINA
26845 A II 12/15/2012 ZHEJIANG CHENG YI PHARMACEUTICAL CO
LTD
RIBAVIRIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
26846 A II 2/7/2013 LAURUS LABS PRIVATE LTD AZACITIDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26847 A II 12/15/2012 ZHEJIANG CHENG YI PHARMACEUTICAL CO
LTD
AZATHIOPRINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
26848 A II 2/13/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
FEBUXOSTAT (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
26849 A II 12/30/2012 ZHEJIANG CHENG YI PHARMACEUTICAL CO
LTD
MERCAPTOPURINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
26850 A II 1/25/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
MAP(VERSION NO.:1) (5R,6S)-3-[(DIPHENOXYPHOSPHINYL)OXYL-6-[(1R)-1-
HYDROXYETHYL]-7-OXO-1-AZABICYCLO[3.2.0]HEPT-2-ENE-2-CARBOXYLIC ACID (4-
NITROPHENYL) METHYL ESTER AS MANUFACTURED IN ZHEJIANG API BASE, P.R. CHINA
26851 A III 1/30/2013 MITSUBISHI GAS CHEMICAL CO INC T-ESTER AS MANUFACTURED IN KANAGAWA, JAPAN
26852 A II 3/15/2013 JUBILANT LIFE SCIENCES LTD APREPITANT (ESUB) AS MANUFACTURED IN MYSORE, INDIA
26853 A III 1/25/2013 REXAM HEALTHCARE OFFRANVILLE SAS EYE DROPPERS SETS (PP SOFT BOTTLES + PP SOFT NOZZLE + HDPE CAPS) AS
MANUFACTURED IN OFFRANVILLE, FRANCE
26854 A IV 2/4/2013 FIRMENICH INC FRAGRANCE FORMULAS AS MANUFACTURED IN PLAINSBORO, NJ
26855 A II 1/30/2013 STERLING SPA FULVESTRANT AS MANUFACTURED IN PERUGIA, ITALY
Page 808
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26856 A II 10/18/2013 CHONGQING SHENGHUAXI
PHARMACEUTICAL CO LTD
AZTREONAM (ESUB) AS MANUFACTURED IN CHONGQING, CHINA
26857 A II 1/28/2013 GANGWAL CHEMICALS PVT LTD ISOXSUPRINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
26858 A III 1/4/2013 ASTRA PLASTIQUE CLOSURE PHARMASAFE MADE OUT OF THERMOPLASTIC MATERIALS AS
MANUFACTURED IN SAINT-GEORGES DE RENEINS, FRANCE
26859 A IV 1/23/2013 HENKEL CORP DURO-TAK 87-4900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
26860 A V 1/29/2013 LUBRIZOL ADVANCED MATERIALS INC TOXICOLOGY AND REGULATORY REVIEW-CARBOMER CLASS OF POLYMERS
26861 A II 2/4/2013 GEDEON RICHTER PLC ULIPRISTAL ACETATE MICRONIZED AS MANUFACTURED IN DOROG, HUNGARY
26862 A II 1/22/2013 CHIRAL QUEST SUZHOU CO LTD (S)-3-METHYLAMINO-1-(THIOPHENE-2-YL)PROPAN-1-OL AS MANUFACTURED IN JIANGXI
PROVINCE, CHINA
26863 A II 2/4/2013 GANGWAL CHEMICALS PVT LTD SALMETEROL XINAFOATE IP/BP AS MANUFACTURED IN MAHARASHTRA, INDIA
26864 A II 3/22/2013 JANSSEN PHARMACEUTICA NV SIMEPREVIR (R494617) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN GEEL,
BELGIUM
26865 A II 2/14/2013 AUROBINDO PHARMA LTD BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
26866 A III 1/30/2013 APTAR FRANCE SAS APTAR ELECTRONIC ANCILLARY COMPONENTS AS MANUFACTURED IN LE VAUDREUIL,
FRANCE; CONGERS, NY, EIGELTINGEN, GERMANY AND RADOLFZELL, GERMANY FOR
APTAR FRANCE S.A.S.
26867 A III 1/30/2013 E-ONEMEDI CONTAINER & CLOSURE AS MANUFACTURED IN CHUNGCHEONGBUK-DO, SOUTH KOREA
26868 A IV 1/22/2013 TIANJIN BOKELIN MEDICAL PACKAGING
TECHNOLOGY CO LTD
SUITTAR AS MANUFACTURED IN TIANJIN, P.R. CHINA
26869 A IV 1/22/2013 TIANJIN BOKELIN MEDICAL PACKAGING
TECHNOLOGY CO LTD
NATRACOLOR AS MANUFACTURED IN TIANJIN, P.R. CHINA
26870 A II 2/7/2013 SYMED LABS LTD KETOROLAC TROMETHAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26871 A II 2/4/2013 RA CHEM PHARMA LTD MIDAZOLAM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26872 A II 1/13/2013 ISOCHEM SAS ECONAZOLE NITRATE AS MANUFACTURED IN VERT LE PETIT, FRANCE
26873 A II 2/1/2013 PHARMACEUTICAL WORKS POLPHARMA SA SODIUM SALICYLATE AS MANUFACTURED IN GDANSKI, POLAND
26874 A III 1/17/2013 HUHTAMAKI RONSBERG SIDE SEALED FLAT POUCH FOR DRUGS APPLIED AS FAST DISSOLVING ORAL FILM AS
MANUFACTURED IN RONSBERG, GERMANY
26875 A III 1/30/2013 HPT HOCHWERTIGE PHARMATECHNIK
GMBH CO KG
ROUND WHITE PE- BOTTLE 300 ML (P-4029) AS MANUFACTURED IN NEUHAUS A. RWG.
GERMANY
26876 A III 1/30/2013 HPT HOCHWERTIGE PHARMATECHNIK
GMBH CO KG
SQUARE WHITE PE- BOTTLE 300 ML (P 4030) AS MANUFACTURED IN NEUHAUS A. RWG.,
GERMANY
26877 A II 5/20/2013 LUPIN LTD BIMATOPROST (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
26878 A II 4/19/2013 LUPIN LTD TRAVOPROST USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
26879 A II 4/12/2013 LUPIN LTD PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26880 A II 3/21/2013 CI NATURMEGA SA OMEGA-3 FISH OIL ETHYL ESTER 84% (ESUB) AS MANUFACTURED IN BARRANQUILLA,
COLOMBIA
26881 A II 2/4/2013 ZHEJIANG LANGHUA PHARMACEUTICAL CO
LTD
SPIRONOLACTONE AS MANUFACTURED IN ZHEJIANG, CHINA
26882 A II 3/25/2013 USV LIMITED NATEGLINIDE USP [MICRONISED] (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26883 A II 2/6/2013 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
MEFLOQUINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI CHINA
Page 809
4Q2012 2Q2014EXCEL
26884 A IV 12/19/2012 HENKEL CORP DURO-TAK 87-9900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
26885 A II 3/27/2013 GLENMARK GENERICS LTD SITAGLIPTIN PHOSPHATE ANHYDROUS (ESUB) AS MANUFACTURED IN GUJARAT STATE,
INDIA
26886 A II 2/13/2013 INTERQUIM SA CELECOXIB AS MANUFACTURED IN BARCELONA, SPAIN
26887 A III 2/6/2013 CODING PRODUCTS SV-17809 AS MANUFACTURED IN KALKASKA, MI
26888 A III 2/11/2013 MULTISORB TECHNOLOGIES STABILOX HEAT SEAL LABEL AS MANUFACTURED IN BUFFALO, NY
26889 A II 11/28/2012 CALYX CHEMICALS AND PHARMACEUTICALS
LTD
VALGANCICLOVIR HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
26890 A II 3/4/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
26891 A II 4/17/2013 SHENZHEN TECHDOW PHARMACEUTICAL
CO LTD
ENOXAPARIN SODIUM USP AS MANUFACTURED IN SHENZHEN CITY, P. R. OF CHINA
26892 A II 2/26/2013 KD PHARMA BEXBACH GMBH EICOSAPENTAENOIC ACID ETHYL ESTER (ESUB) AS MANUFACTURED IN BEXBACH,
GERMANY
26893 A II 3/14/2014 XIAN LIBANG PHARMACEUTICAL CO LTD FULVESTRANT (ESUB) AS MANUFACTURED IN SHAANXI, CHINA
26894 P *** PENDING FILING REVIEW ***
26895 A II 3/1/2013 ULTRAGENYX PHARMACEUTICAL INC TRIHEPTANOIN ULTRAPURE (ESUB) AS MANUFACTURED IN WITTEN, GERMANY FOR
ULTRAGENYX PHARMACEUTICAL INC
26896 A III 2/14/2013 SCHOTT KAISHA PVT LTD GLASS AMPOULES & VIALS AS MANUFACTURED IN GUJARAT, INDIA
26897 A IV 2/13/2013 EVONIK CORP 100 DL MPEG 5000 3.5CE AS MANUFACTURED IN BIRMINGHAM, AL
26898 A IV 2/12/2013 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
9000188 NAT MASKING TYPE FLAVOR AS MANUFACTURED IN COMMERCE, CA
26899 A IV 2/18/2013 FONA INTERNATIONAL INC 877.237 MINT FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
26900 A III 2/20/2013 CADILLAC PRODUCTS PACKAGING CO COMMERCIAL N AS MANUFACTURED IN DALLAS, GEORGIA
26901 A II 3/26/2013 ALKEM LABORATORIES LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26902 A III 2/15/2013 SHL PHARMA LLC EPINEPHRINE AUTO-INJECTOR AS MANUFACTURED IN TAOYUAN, TAIWAN FOR SHL
PHARMA LLC
26903 A IV 2/13/2013 UNGERER AND CO ARTIFICIAL BANANA FLVP FT-8072 AS MANUFACTURED IN BETHLEHEM, PA
26904 A II 2/27/2013 APOTEX FERMENTATION INC SIROLIMUS DRUG SUBSTANCE AS MANUFACTURED IN MANITOBA, CANADA
26905 A IV 2/13/2013 UNGERER AND CO NAT/ART CREME DE VANILLA FLVP FT-8073 AS MANUFACTURED IN BETHLEHEM, PA
26906 A II 3/21/2013 TARO PHARMACEUTICAL INDUSTRIES LTD ATOVAQUONE USP, MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA, ISRAEL
26907 P *** PENDING FILING REVIEW ***
26908 A IV 2/13/2013 UNGERER AND CO ARTIFICAL CARAMEL FLAVOR FV-8873 AS MANUFACTURED IN BETHLEHEM, PA
26909 A II 3/26/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275261] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
26910 P *** PENDING FILING REVIEW ***
26911 A II 2/21/2013 MAC CHEM PRODUCTS INDIA PVT LTD EXEMESTANE AS MANUFACTURED IN DISTRICT THANE, INDIA
26912 A II 9/9/2013 ABX ADVANCED BIOCHEMICAL COMPOUNDS
GMBH
EXAMETAZIME AS MANUFACTURED IN RADEBERG, GERMANY
26913 A II 2/20/2013 NOSCH LABS PRIVATE LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26914 A II 2/21/2013 NOSCH LABS PRIVATE LTD LANSOPRAZOLE, USP AS MANUFACTURED IN ANDHRA PRADESH , INDIA
26915 A V 2/21/2013 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AS LOCATED IN
MILANO, ITALY - VIALE ADDETTA PLANT - STERILE PLANT NO.3
Page 810
4Q2012 2Q2014EXCEL
26916 A III 2/25/2013 MULTIPLAST POLYMER PVT LTD PLASTIC HDPE BOTTLES FOR PHARMACEUTICAL USE AS MANUFACTURED IN
MAHARASHTRA, INDIA
26917 A III 2/22/2013 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL PAPER/ALUMINIUM/BAREX AS MANUFACTURED IN
BURGDORF, SWITZERLAND
26918 A II 2/26/2013 SYNBIAS PHARMA LTD VALRUBICIN USP AS MANUFACTURED IN DONETSK, UKRAINE
26919 A II 2/25/2013 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
TOPIRAMATE USP AS MANUFACTURED IN GUJARAT, INDIA
26920 A III 2/21/2013 LANXESS DEUTSCHLAND GMBH LANXESS BROMOBUTYL 2230 AS MANUFACTURED IN ONTARIO CANADA FOR LANXESS
DEUTSCHLAND GMBH
26921 A II 2/26/2013 MAPRIMED SA ARIPIPRAZOLE AS MANUFACTURED IN BUENOS ARIES, ARGENTINA
26922 A II 3/30/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
TRETINOIN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT. LTD
26923 A II 5/16/2013 MEDICHEM SA MED-200056/E AS MANUFACTURED IN CELRA GIRONA, SPAIN
26924 A II 4/29/2013 MEDICHEM MANUFACTURING MALTA LTD SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN HAL FAR, MALTA
26925 A II 3/25/2013 GLENMARK GENERICS LTD PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
26926 A II 9/27/2013 SPECTRUM PHARMACEUTICALS INC BELINOSTAT DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RENSSELAER, NY FOR
SPECTRUM PHARMACEUTICALS, INC
26927 A II 3/26/2013 JUBILANT LIFE SCIENCES LTD ESLICARBAZEPINE ACETATE (ESUB) AS MANUFACTURED IN NANJANGUD, INDIA
26928 A II 3/28/2013 JUBILANT LIFE SCIENCES LTD LINEZOLID FORM 1 (ESUB) AS MANUFACTURED IN MYSORE DISTRICT, INDIA
26929 A II 3/29/2013 JUBILANT LIFE SCIENCES LTD OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN MYSORE DISTRICT, INDIA
26930 A III 2/27/2013 SURYA POLYCONTAINER PLASTIC HDPE & PP BOTTLES & CLOSURES & PLUGS AS MANUFACTURED IN SILVASSA,
D & NH INDIA
26931 A II 3/14/2013 WISDOM PHARMCEUTICAL CO LTD FLUPIRTINE MALEATE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
26932 A III 2/27/2013 MEDIPHARMAPLAN CO LTD MP-3000 (NON-PVC MEDICAL TUBE FOR IV SOLUTION BAG) MP-5000 (NON-PVC MEDICAL
FILM FOR IV SOLUTION & BLOOD BAG) AS MANUFACTURED IN
CHUNGCHEONGBUK-DO, KOREA
26933 P *** PENDING FILING REVIEW ***
26934 A II 3/31/2013 EMCURE PHARMACEUTICALS LTD COLESEVELAM HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26935 A II 3/28/2013 EMCURE PHARMACEUTICALS LTD RALTEGRAVIR POTASSIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26936 A II 2/28/2013 NEULAND LABORATORIES LTD BRINZOLAMIDE USP (STERILE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26937 A II 3/5/2013 FARMABIOS S P A LOTEPREDNOL ETABONATE AS MANUFACTURED IN PAVIA, ITALY
26938 A II 2/14/2014 GLENMARK GENERICS LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE (D058 PROCESS) (ESUB) AS MANUFACTURED
IN GUJARAT, INDIA
26939 P *** PENDING FILING REVIEW ***
26940 A II 4/11/2013 ARIAD PHARMACEUTICALS INC RIDAFOROLIMUS DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BUBENDORF,
SWITZERLAND FOR ARIAD PHARMACEUTICALS, INC
26941 A IV 2/28/2013 LONZA POLYGLYCEROL-6 AS MANUFACTURED IN WILLIAMSPORT, PA
26942 A II 3/14/2013 WISDOM PHARMCEUTICAL CO LTD TIROFIBAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
26943 A II 3/4/2013 ZHEJIANG YIZHOU CHEMICAL CO LTD TYRAMINE HYDROCHLORIDE (VERSION NO.:1) AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
26944 A II 2/28/2013 CODING PRODUCTS TTR-76356 AS MANUFACTURED IN KALKASKA, MICHIGAN
26945 A II 3/4/2013 PROCOS SPA ILOPERIDONE AS MANUFACTURED IN NOVARA, ITALY
26946 A II 3/4/2013 AK & MN BIOFARM CO LTD EPA ETHYL ESTER 70 AS MANUFACTURED IN ULSAN KOREA
Page 811
4Q2012 2Q2014EXCEL
26947 A II 3/31/2013 EMCURE PHARMACEUTICALS LTD ENOXAPARIN SODIUM USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA
26948 A II 3/29/2013 EMCURE PHARMACEUTICALS LTD DECITABINE MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26949 A II 3/30/2013 EMCURE PHARMACEUTICALS LTD PANTOPRAZOLE SODIUM USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
26950 A II 6/11/2013 EMCURE PHARMACEUTICALS LTD TRIMETHOBENZAMIDE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
26951 A II 3/30/2013 AUROBINDO PHARMA LTD PRASUGREL HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
26952 A III 2/28/2013 PROMENS HF AIR FREE VINCI AND AIR FREE VEGA AS MANUFACTURED IN LANGESKOV, DENMARK
FOR PROMENS HF.
26953 A II 3/7/2013 ZHEJIANG JIUZHOU PHARMACETICAL CO
LTD PLANT NO 3
10- METHOXY IMINOSTILBENE (VERSION NO.:1) AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
26954 A II 3/9/2013 SAURAV CHEMICALS LTD DIETHYLCARBAMAZINE CITRATE AS MANUFACTURED IN PUNJAB, INDIA
26955 A II 3/6/2013 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA SPA
CARGLUMIC ACID AS MANUFACTURED IN LATINA, ITALY
26956 A II 3/29/2013 MSN LABORATORIES PVT LTD DRONEDARONE HYDROCHLORIDE [ROUTE CODE DD] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
26957 A II 4/6/2013 MSN LABORATORIES PVT LTD SILODOSIN [ROUTE CODE - "SD"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
26958 A II 3/30/2013 MSN LABORATORIES PVT LTD PRASUGREL HYDROCHLORIDE [ROUTE CODE PR] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
26959 A II 3/9/2013 SAURAV CHEMICALS LTD DEXKETOPROFEN TROMETAMOL AS MANUFACTURED IN PUNJAB, INDIA
26960 A III 2/25/2013 COSTER TECHNOLOGIE SPECIALI SPA 20MM AEROSOL VALVES AS MANUFACTURED IN TRENTO, ITALY
26961 A II 3/18/2013 SIFAVITOR SRL PIROXICAM AS MANUFACTURED IN LODI, ITALY
26962 A II 3/3/2013 ZHEJIANG NEO DANKONG
PHARMACEUTICAL CO LTD
LINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
TAIZHOU, CHINA
26963 A II 6/28/2013 LUPIN LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26964 A III 3/9/2013 ALUTECH PACKAGING PVT LTD PLAIN, COLOURED AND/OR PRINTED ALU- ALU FOIL "SILPACK" TM PACKAGING MATERIAL
AND ALUMINIUM FOILS FOR PHARMACEUTICAL, MEDICAL, BIOLOGICAL AND FOOD
INDUSTRY AS MANUFACTURED IN NEW DELHI, INDIA
26965 A II 3/8/2013 CHANGZHOU PHARMACEUTICAL FACTORY AGOMELATINE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
26966 A II 1/29/2013 FINECURE PHARMACEUTICALS LTD FINEMOX CV 625 (CO- AMOXICLAV TABLETS BP 625 MG) AS MANUFACTURED IN
UTTARAKHAND, INDIA
26967 A II 3/5/2013 RAKS PHARMA PVT LTD ESCITALOPRAM OXALATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26968 A II 12/6/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275266] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
26969 A II 3/6/2013 FRESENIUS KABI ANTI INFECTIVES SRL CEPHAPIRIN BENZATHINE STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY
26970 A II 12/8/2012 OMKAR SPECIALITY CHEMICALS LTD SELENIUM SULFIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
26971 A II 3/4/2013 ZHEJIANG JIANGBEI PHARMACEUTICAL CO
LTD
SIMVASTATIN AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
26972 A II 4/1/2013 MSN LABORATORIES PVT LTD EZETIMIBE [ROUTE CODE - EZ] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26973 A II 3/23/2013 MSN ORGANICS PVT LTD ASENAPINE MALEATE [ROUTE CODE "AOI"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26974 A II 4/5/2013 MSN PHARMACHEM PVT LTD SITAGLIPTIN PHOSPHATE ANHYDROUS [ROUTE CODE - "SA"] (ESUB) AS MANUFACTURED
IN ANDHRA PRADESH, INDIA
Page 812
4Q2012 2Q2014EXCEL
26975 A II 4/29/2013 MSN LABORATORIES PVT LTD ALISKIREN HEMIFUMARATE [ROUTE CODE - "AF"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
26976 A II 3/26/2013 ALEMBIC PHARMACEUTICALS LTD API DIV DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26977 A II 5/3/2013 GLENMARK GENERICS LTD SAXAGLIPTIN MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
26978 A II 6/21/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD CASPOFUNGIN ACETATE (ESUB) AS MANUFACTURED IN UTTAR PRADESH, INDIA AND
DEBRECEN, HUNGARY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
26979 A II 3/15/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
V5537 (3-(2-AMINOETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-4H-PYRIDO{1,2-A}PYRIMIDINE-4-
ONE,DIHYDROCHLORIDE)(VERSION NO.:1) AS MANUFACTURED IN ZHEJIANG PROVINCE,
CHINA
26980 A II 3/15/2013 ZHEJIANG ZONE BANNER CHEMICAL CO LTD 1-[2-AMINO-1-(4-METHOXYPHENYL)ETHYL]-CYCLOHEXANOL HYDROCHLORIDE (VERSION
NO.:1) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26981 A III 2/14/2012 SANWARIYA PACKAGING PVT LTD PRINTED BLISTER ALUMINIUM FOIL FOR PHARMACEUTICAL USE AS MANUFACTURED IN
MADHYA PRADESH, INDIA
26982 A II 3/12/2013 ZHEJIANG ZONE BANNER CHEMICAL CO LTD 2-(3-BENZOYLPHENYL) PROPANENITRILE (VERISION NO.:1) AS MANUFACTURED IN
ZHEJIANG PROVINCE, CHINA
26983 A II 3/14/2013 HANGZHOU HUADONG MEDICINE GROUP
KANGRUN PHARMACEUTICAL CO LTD
SIROLIMUS (INTERMEDIATE) AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
26984 A II 3/12/2013 EDMOND PHARMA SRL DEXMEDETOMIDINE HCI AS MANUFACTURED IN MILANO, ITALY
26985 A III 3/6/2013 MS JINDAL ALUMINIUM LTD HEAT SEAL LACQUER COATED BLISTER FOIL (PLAIN /PRINTED) AS MANUFACTURED IN
KARNATAKA, INDIA
26986 A III 2/27/2013 LINHARDT GMBH AND CO KG LAMINATED TUBES FOR THE COSMETIC, PHARMACEUTICAL OR FOOD SECTOR AS
MANUFACTURED IN HAMBRUCKEN, GERMANY AND PAUSA, GERMANY FOR LINHARDT
GMBH AND CO. KG
26987 A III 3/6/2013 MS JINDAL ALUMINIUM LTD POLY LAMINATED STRIP FOIL (PLAIN /PRINTED) AS MANUFACTURED IN KARNATAKA, India
26988 A III 3/6/2013 MS JINDAL ALUMINIUM LTD BARE ALUMINIUM FOIL AS MANUFACTURED IN KARNATAKA, INDIA
26989 A III 3/6/2013 MS JINDAL ALUMINIUM LTD PRINTED ALUMINIUM FOIL AS MANUFACTURED IN BANGALORE, INDIA
26990 A III 3/6/2013 MS JINDAL ALUMINIUM LTD OPA (ORIENTED POLY AMIDE) / ALUMINIUM FOIL/PVC LAMINATE AS MANUFACTURED IN
KARNATAKA, INDIA
26991 A III 3/15/2013 CHROMA CORP PC302483C PINK COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS
26992 A II 3/20/2013 HETERO LABS LTD OLMESARTAN MEDOXMIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
26993 A II 3/29/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD CAPECITABINE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
26994 A III 3/19/2013 DAIKIN INDUSTRIES LTD NEOFLON PCTFE FILM AS MANUFACTURED IN JIANGSU, CHINA; INNER MONGOLIA, CHINA
AND SHANGHAI, P.R. CHINA FOR DAIKIN INDUSTRIES, LTD.
26995 A II 3/15/2013 ERREGIERRE SPA ZILEUTON USP AS MANUFACTURED IN BERGAMO, ITALY
26996 A II 3/7/2013 ULKAR KIMYA SANAYII VE TICARET AS CANDESARTAN CILEXETIL USP AS MANUFACTURED IN TEKIRDAG, TURKEY
26997 A II 3/7/2013 ULKAR KIMYA SANAYII VE TICARET AS PANTOPRAZOLE SODIUM SESQUIHYDRATE USP AS MANUFACTURED IN TEKIRDAG,
TURKEY
26998 A III 3/20/2013 V SANTOS SA GLASS PACKAGING FOR PHARMACEUTICALS AS MANUFACTURED IN MADRID, SPAIN
26999 A II 3/20/2013 KOHJIN BIO CO LTD LIQUID CELL GROWTH MEDIUM FOR HUMAN CELLS AS MANUFACTURED IN SAITAMA,
JAPAN
27000 P *** PENDING FILING REVIEW ***
27001 A III 3/12/2013 BORMIOLI ROCCO SPA BU PLASTICA PP MEASURING CUP AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO
(PV), ITALY; AND SAINT SULPICE, FRANCE FOR BORMIOLI ROCCO SPA- BU PLASTICA
Page 813
4Q2012 2Q2014EXCEL
27002 A II 3/15/2013 SHIJIAZHUANG LONZEAL
PHARMACEUTICALS CO LTD
LAMIVUDINE FORM I AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA
27003 A III 3/15/2013 CHARTER NEX FILMS INC 323456A AS MANUFACTURED IN TURNERS FALLS, MA
27004 A III 3/14/2013 AMPACET CORP 465798 MYLAN BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OHIO
27005 A II 3/2/2013 SUPRIYA LIFESCIENCE LTD RIBOFLAVIN 5' - PHOSPHATE SODIUM (USP + IH) AS MANUFACTURED IN MAHARASHTRA,
INDIA
27006 A II 6/6/2013 EXCELLA GMBH BUSULFAN (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY
27007 A II 4/12/2013 LUPIN LTD LAMIVUDINE (PROCESS-B) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27008 A II 3/21/2013 FARMABIOS S P A DELTA-1-CORTIENIC ACID AS MANUFACTURED IN PAVIA, ITALY
27009 A III 3/25/2013 HEINKE TECHNOLOGY INC TABLET DISPENSING VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN, NE
27010 A III 2/28/2013 UNITED CLOSURES AND PLASTICS LTD 24MM MEDI-LOC CLOSURES AS MANUFACTURED IN NORWICH, ENGLAND
27011 I II 3/26/2013 ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDUTASTERIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA
27012 A III 3/26/2013 SHINKO CHEMICAL CO LTD EYEDROP CONTAINER RT-5 AS MANUFACTURED IN ISHIKAWA, JAPAN
27013 A III 3/27/2013 MITSUBISHI CHEMICAL CORP RABALON AS MANUFACTURED IN MIE, JAPAN
27014 A IV 3/26/2013 FONA INTERNATIONAL INC 884.010 N-C ORANGE CREAM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
27015 A III 3/20/2013 C AND K PROPACK CO LTD ALUALU AS MANUFACTURED IN GYENGGI-DO, KOREA
27016 A IV 3/12/2013 SIGACHI CELLULOS P LTD MICRO CRYSTALLINE CELLULOSE AS MANUFACTURED IN GUJARAT, INDIA
27017 A II 3/26/2013 SIGMA ALDRICH IRELAND LTD BENZYL ALCOHOL AS MANUFACTURED IN ARKLOW, IRELAND
27018 A II 9/18/2013 LIANYUNGANG RUNZHONG
PHARMACEUTICAL CO LTD
BENDAMUSTINE HCL(ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27019 A III 3/20/2013 CONSOLIDATED BOTTLE CORP 8 GALLON BLUE OPEN HEAD DRUM WITH LEVER LOCK BAND, BLACK PE COVER & WHITE
RUBBER GASKET AS MANUFACTURED IN SWEETWATER, TENNESSEE FOR
CONSOLIDATED BOTTLE CORPORATION
27020 A IV 3/28/2013 WILSHIRE TECHNOLOGIES INC PHYTOCHOL AS MANUFACTURED IN SAYREVILLE, NJ AND OVERLAND, MO FOR WILSHIRE
TECHNOLOGIES INC
27021 A II 4/9/2013 AUROBINDO PHARMA LTD METHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
27022 A II 3/29/2013 STERLING SPA MOMETASONE FUROATE MONOHYDRATE (D90<10UM) AS MANUFACTURED IN PERUGIA,
ITALY
27023 A II 4/1/2013 OMNIABIOS S.R.L. S-ADENOSYL-L-METHIONINE DISULFATE TOSYLATE [SAM-PTS] DRY POWDER AS
MANUFACTURED IN BRESCIA, ITALY
27024 N NOT AN ASSIGNED NUMBER
27025 A II 10/30/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275282] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
27026 A II 4/2/2013 MAC CHEM PRODUCTS INDIA PVT LTD CAPECITABINE AS MANUFACTURED IN DISTRICT THANE, INDIA
27027 A II 4/2/2013 MAC CHEM PRODUCTS INDIA PVT LTD ROPIVACAINE HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN DISTRICT
THANE, INDIA
27028 A II 4/2/2013 MAC CHEM PRODUCTS INDIA PVT LTD OXALIPLATIN AS MANUFACTURED IN DISTRICT THANE, INDIA
27029 A III 4/1/2013 COLORS FOR PLASTICS INC R34215 RED/1797C COLORANT MASTERBATCH AS MANUFACTURED IN ELK GROVE
VILLAGE, IL AND SPARTANBURG, SC
27030 A II 3/25/2013 GW PHARMA LTD GWP42003-P* AS MANUFACTURED IN KENT, UNITED KINGDOM
27031 A II 4/1/2013 UNIMAX CHEMICALS PVT LTD ERYTHROMYCIN (HIGH PURITY) AS MANUFACTURED IN DISTRICT THANE, INDIA
27032 A II 3/29/2013 JOHNSON MATTHEY PHARMA SERVICES 4235.D AS MANUFACTURED IN DEVENS, MA
27033 A II 4/3/2013 KYONGBO PHARMACEUTICAL CO LTD CEFIXIME BULK AS MANUFACTURED IN CHUNGCHEONGNAM-DO, REPUBLIC OF KOREA
Page 814
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27034 A III 3/25/2013 SVAM PACKAGING INDUSTRIES PVT LTD "ALUBLIS/TROBLIS" COLD FORMING BLISTER FOIL (ALU-ALU FOIL) AS MANUFACTURED IN
HARYANA, INDIA
27035 A II 3/29/2013 CONTIPRO PHARMA AS SODIUM HYALURONATE AS MANUFACTURED IN DOLNI DOBROUC, CZECH REPUBLIC
27036 A II 7/10/2013 MALLINCKRODT INC COMPAP SDCRSL (ESUB) AS MANUFACTURED IN GREENVILLE, ILLINOIS
27037 A II 6/29/2013 MSN LABORATORIES PVT LTD DABIGATRAN ETEXILATE MESYLATE [ROUTE CODE - "DE"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27038 A II 4/20/2013 MSN PHARMACHEM PVT LTD DARUNAVIR [ROUTE CODE - "DI"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27039 A II 5/16/2013 MSN ORGANICS PVT LTD ILOPERIDONE [ROUTE CODE - "IO"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27040 A II 5/16/2013 MSN PHARMACHEM PVT LTD VILDAGLIPTIN [ROUTE CODE - "VG''] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27041 A II 5/28/2013 MSN PHARMACHEM PVT LTD MONTELUKAST SODIUM [ROUTE CODE - "MK"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27042 A II 5/31/2013 MSN LABORATORIES PVT LTD UNIT II ERLOTINIB HYDROCHLORIDE [ROUTE CODE - "ER"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27043 A II 5/30/2013 MSN LABORATORIES PVT LTD UNIT II GEMCITABINE HYDROCHLORIDE USP [ROUTE CODE - "GH"] AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27044 A II 5/29/2013 MSN LABORATORIES PVT LTD UNIT II BIMATOPROST [ROUTE CODE - "BM"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27045 A II 4/19/2013 SRI KRISHNA PHARMACEUTICALS LTD GLYBURIDE USP (ESUB) AS MANUFACTURED IN A. P., INDIA
27046 P *** PENDING FILING REVIEW ***
27047 A II 9/16/2013 MACLEODS PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN VALSAD, INDIA
27048 A II 6/12/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO,
CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
27049 A II 4/3/2013 HAINAN YEW PHARMACEUTICAL CO LTD PACLITAXEL (SEMI-SYNTHETIC) AS MANUFACTURED IN HAINAN PROVINCE, P.R. CHINA
27050 A III 4/1/2013 LOTTE CHEMICAL J-560M AS MANUFACTURED IN DAEJON, KOREA
27051 A II 4/1/2013 ST GOBAIN PERFORMANCE PLASTICS CORP C- FLEX R70-082 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL
27052 A II 4/3/2013 HETERO DRUGS LTD TOLVAPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27053 A III 3/27/2013 COLORTECH INC 11616-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN,
TENNESSEE AND ONTARIO, CANADA
27054 A II 4/1/2013 ST GOBAIN PERFORMANCE PLASTICS CORP C-FLEX R70-050 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL
27055 A IV 4/1/2013 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT, PRESOME SIIG AS MANUFACTURED IN HYOGO, JAPAN
27056 A II 4/1/2013 ST GOBAIN PERFORMANCE PLASTICS CORP C-FLEX R70-072 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL
27057 A II 4/1/2013 ST GOBAIN PERFORMANCE PLASTICS CORP C-FLEX R70-374 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL
27058 A II 4/1/2013 ST GOBAIN PERFORMANCE PLASTICS CORP C-FLEX R70-001 TPE TUBING AS MANUFACTURED IN CLEARWATER, FL
Page 815
4Q2012 2Q2014EXCEL
27059 A II 6/7/2013 NOVARTIS PHARMACEUTICALS CORP TERBINAFINE (ESUB) AS MANUFACTURED IN BASEL, SWITZERLAND AND RINGASKIDDY,
IRELAND FOR NOVARTIS PHARMACEUTICALS CORPORATION
27060 A II 7/31/2013 ENTERIS BIOPHARMA INC RECOMBINANT PEPTIDE UGP302 (ESUB) AS MANUFACTURED IN BOONTON, NJ
27061 A II 3/21/2013 CATALENT FRANCE BEINHEIM SA 211002432 AS MANUFACTURED IN BEINHEIM, FRANCE
27062 A III 3/22/2013 PROMENS HF KIDPOT AS MANUFACTURED IN GEOVREISSET, FRANCE
27063 A III 3/27/2013 ESSEL DE MEXICO SA DE CV 'PRINTED LAMINATES & LAMINATED TUBES AS MANUFACTURED IN EXHACIENDA SAN
MIGUEL, MEXICO
27064 A II 5/6/2013 CADILA PHARMACEUTICALS LTD RALOXIFENE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27065 A III 3/30/2013 SAGAR RUBBER PRODUCTS PVT LTD RFS & RFU RUBBER CLOSURE (RUBBER STOPPER) FOR INJECTABLES AS
MANUFACTURED IN GUJARAT, INDIA
27066 A II 4/5/2013 KYONGBO PHARMACEUTICAL CO LTD ENTECAVIR AS MANUFACTURED IN CHUNGCHEONGNAM-DO, REPUBLIC OF KOREA
27067 A II 3/15/2013 PJ HEALTHCARE AZITHROMYCIN TASTE MASKING GRANULES 7.5% AS MANUFACTURED IN GUJARAT, India
27068 A III 4/8/2013 BADGER COLOR CONCENTRATES INC PLASTIC COLORANTS AS MANUFACTURED IN MUKWONAGO, WI AND KINGS MOUNTAIN,
NC
27069 A II 4/2/2013 VIWIT PHARMACEUTICAL CO LTD ELETRIPTAN HYDROBROMIDE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN
SHANDONG, CHINA
27070 A II 4/8/2013 CAMBREX CHARLES CITY INC SGD-1910 AS MANUFACTURED IN CHARLES CITY, IA
27071 A II 6/14/2014 NECTAR LIFESCIENCES LTD CEFPODOXIME PROXETIL USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
27072 A IV 4/6/2013 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT, HYDROGENATED PHOSPHATIDYLCHOLINE (SOY), HSPC AS
MANUFACTURED IN HYOGO, JAPAN
27073 A II 4/8/2013 JOST CHEMICAL CO MAGNESIUM CITRATE TRIBASIC ANHYDROUS AS MANUFACTURED IN ST. LOUIS, MO
27074 A IV 4/11/2013 FONA INTERNATIONAL INC 805.018 BANANA FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
27075 A III 4/11/2013 POLYONE CORP CC10130826WE (SELSUN BLUE PEARL) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
27076 A II 4/2/2013 HANGZHOU HONRY BIOTECH CORP DORZOLOMIDE HYDROCHLORIDE AS MANUFACTURED IN HANGZHOU CITY, CHINA
27077 A II 6/14/2013 LUPIN LTD ILOPERIDONE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR LUPIN LTD
27078 A II 5/20/2013 APOTEX PHARMACHEM INDIA PVT LTD PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA
27079 A III 4/10/2013 REXAM HEALTHCARE NOVELIA (R) PRESERVATIVE FREE SYSTEM AS MANUFACTURED IN LA VERPILLIERE
CEDEX, FRANCE
27080 A III 4/9/2013 AMPACET CORP 150217 PEACH PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA;
CATERSVILLE, GA AND HEATH, OH
27081 A II 5/24/2013 KAKEN PHARMACEUTICAL CO LTD EFINACONAZOLE AS MANUFACTURED IN GIFU PREF, JAPAN FOR KAKEN
PHARMACEUTICAL CO., LTD
27082 A II 4/20/2013 ALP PHARM BEIJING CO LTD SILODOSIN (ESUB) AS MANUFACTURED SHANDONG, CHINA FOR ALP PHARM BEIJING
CO., LTD
27083 A II 7/17/2013 WOCKHARDT BIO AG SAXAGLIPTIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
FOR WOCKHARDT BIO AG
27084 A II 5/27/2013 WOCKHARDT BIO AG SITAGLIPTIN PHOSPHATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR
WOCKHARDT BIO AG
27085 A II 4/2/2013 QILU TIANHE PHARMACEUTICAL CO LTD CAPECITABINE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
27086 A II 5/17/2013 MYLAN LABORATORIES LTD ASENAPINE MALEATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27087 A II 5/9/2013 LAURUS LABS PRIVATE LTD TENOFOVIR DISOPROXIL FUMARATE (PROCESS-2) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27088 A II 5/8/2013 APOTEX PHARMACHEM INDIA PVT LTD DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA
Page 816
4Q2012 2Q2014EXCEL
27089 A II 5/9/2013 LAURUS LABS PRIVATE LTD IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27090 A III 4/18/2013 TORAY INDUSTRIES INC POLYETHYLENE TEREPHTHALATE RESIN T-290M
27091 P *** PENDING FILING REVIEW ***
27092 A II 5/2/2013 DR REDDYS LABORATORIES LTD 20 KDA METHOXYPOLY(ETHYLENE GLYCOL) PROPIONALDEHYDE (ESUB) AS
MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM
27093 A II 5/24/2013 BIOCON SA INSULIN GLARGINE (RDNA ORIGIN) (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
FOR BIOCON SA
27094 A III 3/11/2013 PHARMA TRADE SRL CRIMP CAPS FOR PHARMACEUTICALS AND COSMETICS USED AS SECONDARY
PACKAGING AS MANUFACTURED IN VASTO (CH), ITALY
27095 A III 4/2/2013 JINAN LINUO GLASSWORK CO LTD NEUTRAL BOROSILICATE GLASS AMPOULE AS MANUFACTURED IN JINAN, P.R. CHINA
27096 A III 4/2/2013 JINAN LINUO GLASSWORK CO LTD NEUTRAL BOROSILICATE GLASS TUBULAR VIAL AS MANUFACTURED IN JINAN, P.R.
CHINA
27097 A II 4/19/2013 ZHEJIANG LIAOYUAN PHARMACEUTICALS
CO., LTD.
(+)-METHYL-(2-CHLOROPHENYL)-(2-THIOPHEN-2YL-ETHYLAMINO) ACETATE
HYDROCHLORIDE AS MANUFACTURED IN LINHAI CITY, P.R. CHINA
27098 A II 8/2/2013 MEGHMANI UNICHEM LLP ACETAMINOPHEN, USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27099 A III 3/14/2013 VERSALIS SPA ERACLENE MP 90U AS MANUFACTURED IN BRINDISI, ITALY
27100 A III 3/14/2013 VERSALIS SPA ERACLENE BB 82 AS MANUFACTURED IN BRINDISI, ITALY
27101 A III 4/19/2013 TECTUBES SWEDEN AB PLASTIC AND ALMINUM TUBES AS MANUFACTURED IN HJO, SWEDEN AND ASTORP,
SWEDEN
27102 A II 5/13/2013 SUN PHARMACEUTICAL INDUSTRIES LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27103 A III 4/22/2013 BD MEDICAL PHARMACEUTICAL SYSTEMS BD NEOPAK (STERILE) SYRINGE SYSTEM AS MANUFACTURED IN LE PONTE-DE-CLAIX,
FRANCE AND COLUMBUS, NEBRASKA
27104 A II 5/10/2013 SUN PHARMACEUTICAL INDUSTRIES LTD PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27105 A II 4/26/2013 PIRAMAL ENTERPRISES LTD METAXALONE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27106 A II 5/7/2013 AUROBINDO PHARMA LTD PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED
IN ANDHRA PRADESH, INDIA
27107 A II 4/24/2013 TRIFARMA SPA ZOLEDRONIC ACID AS MANUFACTURED IN (MB), ITALY
27108 A III 4/15/2013 BOREALIS AG BORMED LE6607-PH AS MANUFACTURED IN SCHWECHAT- MANNSWORTH, AUSTRIA FOR
BOREALIS AG
27109 A II 4/20/2013 HEC PHARM USA INC ENTACAPONE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU CITY,
P.R. CHINA FOR HEC PHARM USA INC
27110 A II 7/29/2013 ABX ADVANCED BIOCHEMICAL COMPOUNDS
GMBH
ABX-[18F]FDG CASSETTE FOR GE TRACERLAB MX SYNTHESIZER AS MANUFACTURED IN
RADEBERG, GERMANY
27111 A II 5/9/2013 AUROBINDO PHARMA LTD SAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
27112 A IV 4/29/2013 FONA INTERNATIONAL INC 915.0642U N-C STRAWBERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
27113 A III 4/12/2013 KEY INTERNATIONAL INC PLASTIC POLYMER ALLOY AS MANUFACTURED IN CRANBURY, NJ
27114 A II 4/18/2013 JIANSHI YUANTONG BIOENGINEERING CO
LTD
HESPERIDIN AS MANUFACTURED IN ENSHI, CHINA
27115 A II 4/22/2013 CHIRAL QUEST SUZHOU CO LTD (R)-3-(TERT-BUTOXYCARBONYLAMINO)-4-(2,4,5-TRIFLUOROPHENYL)BUTANOIC ACID AS
MANUFACTURED IN SUZHOU, P.R. CHINA
27116 A II 6/4/2013 PHF SA LENALIDOMIDE (ESUB) AS MANUFACTURED IN OLAINE, LATVIA FOR PHF SA
27117 A II 4/30/2013 BILLICUM PHARMACEUTICALS, INC. AP1903 INJECTION AS MANUFACTURED IN CHARLESTON, SOUTH CAROLINA
27118 A III 4/9/2013 AXIUM PLASTICS HDPE BOTTLES AS MANUFACTURED IN NEW ALBANY, OH AND LAWRENCEVILLE, GA
Page 817
4Q2012 2Q2014EXCEL
27119 A II 5/1/2013 HETERO DRUGS LTD PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27120 A II 4/30/2013 INDUSTRIALE CHIMICA SRL TIOTROPIUM BROMIDE METHANOL SOLVATE AS MANUFACTURED IN SARONNO, ITALY
27121 A II 4/29/2013 COVALENT LABORATORIES PRIVATE LTD CEFIXIME USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27122 P *** PENDING FILING REVIEW ***
27123 A II 7/7/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD EXENATIDE (ESUB) AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
27124 A II 7/3/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD GABAPENTIN BUTANOL PROCESS (ESUB) AS MANUFACTURED IN VILLANTERIO PAVIA,
ITALY FOR TEVA PHARMACEUTICALS INDUSTRIES LTD
27125 A II 7/3/2013 PAR PHARMACEUTICAL INC GLYCEROL PHENYLBUTYRATE (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA FOR
PAR PHARMACEUTICAL, INC
27126 A III 5/3/2013 MITSUBISHI CHEMICAL CORP ZELAS 7025 AS MANUFACTURED IN MIE, JAPAN
27127 A III 5/15/2013 VORA PACKAGING PVT. LTD. BOTTLE CAP SEALS & LINERS (EXPANDED POLYETHYLENE CAP LINERS & INDUCTION
HEAT SEALS) AS MANUFACTURED IN MAHARASHTRA, INDIA
27128 A II 7/22/2013 EPAX NORWAY AS EPAX 6015 TGN US API (ESUB) AS MANUFACTURED IN AALESUND, NORWAY
27129 A III 5/3/2013 BEYONDEVICES LDA VAGINAL APPLICATOR AS MANUFACTURED IN SOBRAL DE MONTE AGRACO, PORTUGAL
27130 A II 4/26/2013 ONO PHARMACEUTICAL CO LTD ALPROSTADIL ALFADEX AS MANUFACTURED IN SHIZUOKA, JAPAN
27131 A II 6/2/2000 NEKTAR THERAPEUTICS METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL CARBONATE, MW 12, 000 AS
MANUFACTURED IN HUNSTSVILLE, AL
27132 A II 5/22/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
TOLVAPTAN (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27133 A II 5/2/2013 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
GANCICLOVIR USP (NON-STERILE API) AS MANUFACTURED IN XIANHU, P.R. CHINA
27134 A IV 5/1/2013 NUSIL TECHNOLOGY LLC DDU-4353 SILICONE AS MANUFACTURED IN CARPINTERIA, CA
27135 A II 5/31/2013 APOTEX PHARMACHEM INDIA PVT LTD TETRABENAZINE AS MANUFACTURED IN BANGALORE, INDIA
27136 A III 5/17/2011 THE JENARD CO DIV FEY INDUSTRIES INC SLEEVE FOR THE PROTECTION OF A MULTI-DOSAGE PHARMACEUTICAL BLISTER
PACKAGE AS MANUFACTURED IN EDGERTON , MN
27137 A III 5/2/2013 JAUSS POLYMER LTD PET BOTTLES FOR PHARMACEUTICALS AS MANUFACTURED IN HIMACHAL PRADESH,
INDIA
27138 A II 11/10/2000 NEKTAR THERAPEUTICS METHOXYPOLY (ETHYLENE GLYCOL)- PROPIONALDEHYDE, MW 20, 000 AS
MANUFACTURED IN HUNSTSVILLE, AL
27139 A II 5/6/2013 IOL CHEMICALS AND PHARMACEUTICALS
LTD
METFORMIN HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA
27140 A II 4/25/2013 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM SODIUM (STERILE API) AS MANUFACTURED IN JINAN, CHINA
27141 P *** PENDING FILING REVIEW ***
27142 N NOT AN ASSIGNED NUMBER
27143 A II 5/8/2013 ACEBRIGHT INDIA PHARMA PRIVATE LTD TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)] AS
MANUFACTURED IN KARNATAKA, INDIA
27144 A II 6/25/2013 MYLAN LABORATORIES LTD PITAVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27145 A II 5/4/2013 MICROBIOPHARM JAPAN CO LTD PARICALCITOL, USP AS MANUFACTURED IN SHIZUOKA, JAPAN
27146 A II 6/26/2013 MYLAN LABORATORIES LTD SAXAGLIPTIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27147 A II 6/28/2013 MYLAN LABORATORIES LTD TETRABENAZINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27148 A III 1/9/2013 CHING HAI CHEMICAL INDUSTRIAL CO LTD SILICA GEL AS MANUFACTURED IN DALI CITY, TAIWAN (R.O.C)
27149 I II 12/14/1988 BACHEM AG (H-GLY-HIS-LYS-OH) 2 COPPER CHELATE MANUFACTURED IN BUBENDORF,
SWITZERLAND. Page 818
4Q2012 2Q2014EXCEL
27150 N NOT AN ASSIGNED NUMBER
27151 N NOT AN ASSIGNED NUMBER
27152 N NOT AN ASSIGNED NUMBER
27153 N NOT AN ASSIGNED NUMBER
27154 N NOT AN ASSIGNED NUMBER
27155 P *** PENDING FILING REVIEW ***
27156 A II 6/14/2013 XELLIA PHARMACEUTICALS APS CASPOFUNGIN (ACETATE) (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR XELLIA
PHARMACEUTICALS APS
27157 N NOT AN ASSIGNED NUMBER
27158 N NOT AN ASSIGNED NUMBER
27159 A II 5/21/2013 RAKS PHARMA PVT LTD TRAMADOL HYDROCHLORIDE USP API (PROCESS-2) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27160 N NOT AN ASSIGNED NUMBER
27161 A II 5/31/2013 RAKS PHARMA PVT LTD DRONEDARONE HYDROCHLORIDE API (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27162 A II 8/6/2013 INDENA SPA PACLITAXEL/S SEMISYNTHETIC PROCESS, USP/EP (ESUB) AS MANUFACTURED IN
SETTALA (MI), ITALY
27163 A III 3/28/2013 WEST PHARMACEUTICAL SERVICES INC DAIKYO CRYSTAL ZENITH READY-TO-USE - CARTRIDGE SYSTEM AS MANUFACTURED IN
TOCHIGI, JAPAN
27164 A II 5/21/2013 AMOLI ORGANICS PVT LTD OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27165 A II 5/22/2013 AMRI RENSSELAER INC DIATRIZOATE MEGLUMINE, USP AS MANUFACTURED IN RENSSELAER, NEW YORK
27166 A II 6/28/2013 DR REDDYS LABORATORIES LTD ESZOPICLONE [PROCESS-3] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27167 A II 5/31/2013 APOTEX PHARMACHEM INDIA PVT LTD EXEMESTANE AS MANUFACTURED IN BANGALORE, INDIA
27168 A II 6/11/2013 AUROBINDO PHARMA LTD MEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA FOR AUROBINDO PHARMA LIMITED
27169 A II 12/12/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-00775174] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
27170 A II 7/3/2013 MEDICHEM MANUFACTURING MALTA LTD BEPOTASTINE BESILATE AS MANUFACTURED IN HAL FAR, MALTA
27171 A II 5/31/2013 APOTEX PHARMACHEM INDIA PVT LTD OLOPATADINE HYDROCHLORIDE USP AS MANUFACTURED IN BANGALORE, INDIA
27172 A II 5/6/2013 NEWGEN BIOTECH INC SERRAPEPTASE AS MANUFACTURED IN NINGBO CITY, CHINA
27173 A II 5/6/2013 NEWGEN BIOTECH INC BROMELAIN AS MANUFACTURED IN NINGBO CITY, CHINA
27174 A II 6/27/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD SAXAGLIPTIN MONOHYDRATE (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO
CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
27175 A III 8/28/2013 FRANPLAST SRL CHEMITON HMB SERIES AS MANUFACTURED IN PROVAGLIO D'ISEO (BS), ITALY
27176 A III 5/13/2013 CHROMA CORP PC23258B WHITE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS
27177 A III 5/13/2013 CHROMA CORP PC23258A WHITE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS
27178 A III 5/13/2013 CHROMA CORP PC56252C BLUE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS
27179 A II 7/16/2013 XELLIA PHARMACEUTICALS LTD DAPTOMYCIN (ESUB) AS MANUFACTURED IN BUDAPEST, HUNGARY FOR XELLIA
PHARMACEUTICALS LTD
27180 A II 5/24/2013 HARMAN FINOCHEM LTD LIDOCAINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
27181 A II 6/7/2013 NEW ZEALAND PHARMACEUTICALS LTD CHOLIC ACID (ESUB) AS MANUFACTURED IN PALMERSTON NORTH, NEW ZEALAND
27182 A II 5/23/2013 FINORGA SAS ICOSAPENT ETHYL AS MANUFACTURED IN MOURENX, FRANCE
27183 A III 5/9/2013 CANADA COLORS AND CHEMICALS LTD DBA
CCC PLASTICS
WHITE MB50-949POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN
ONTARIO, CANADA
27184 A IV 5/15/2013 NOVO EXCIPIENTS PVT LTD NOVOMIX AS MANUFACTURED IN MAHARASHTRA, INDIA
Page 819
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27185 A II 7/17/2013 SUN PHARMACEUTICAL INDUSTRIES LTD ASENAPINE MALEATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27186 A II 8/9/2013 SUN PHARMACEUTICAL INDUSTRIES LTD TETRABENAZINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27187 A II 6/24/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275265] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
27188 A II 9/13/2013 CEDARBURG PHARMACEUTICALS INC RIBOFLAVIN 5'-PHOSPHATE SODIUM AS MANUFACTURED IN GRAFTON, WISCONSIN
27189 A II 6/14/2013 RAKS PHARMA PVT LTD SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE API (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27190 A II 9/2/2013 RAKS PHARMA PVT LTD OMEPRAZOLE MAGNISIUM, USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27191 A IV 5/15/2013 NOVO EXCIPIENTS PVT LTD NOVOPOWER AS MANUFACTURED IN MAHARASHTRA, INDIA
27192 A II 6/18/2013 AURONEXT PHARMA PRIVATE LTD MEROPENEM FOR INJECTION (STERILE BULK) (ESUB) AS MANUFACTURED IN
RAJASTHAN, INDIA
27193 A III 5/5/2013 TULSTAR PRODUCTS INC PCTFE RESIN AS MANUFACTURED IN INNER MONGOLIA, CHINA FOR TULSTAR
PRODUCTS, INC.
27194 A II 7/4/2013 ALEMBIC PHARMACEUTICALS LTD API DIV ASENAPINE MALEATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27195 A II 5/24/2013 TIANJIN TIANYAO PHARMACEUTICALS CO
LTD
DEXAMETHASONE SODIUM PHOSPHATE, USP BULK AS MANUFACTURED IN TIANJIN,
CHINA
27196 A II 5/30/2013 HOVIONE FARMACIENCIA SA BECLOMETHASONE DIPROPIONATE MONOHYDRATE USP AS MANUFACTURED IN
LOURES, PORTUGAL
27197 A II 5/30/2013 HETERO DRUGS LTD RISEDRONATE SODIUM HEMI-PENTAHYDRATE, UPS AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27198 A II 6/10/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
LOSARTAN POTASSIUM, USP (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27199 A IV 5/15/2013 FRUTAROM USA CHERRY SPRAY DRIED NATURAL TYPE FLAVOR 3209187501.00 AS MANUFACTURED IN
CORONA, CA
27200 A III 5/29/2013 MEYER SEALS ALFELDER
KUNSTSTOFFWERKE HERM MEYER GMBH
CLOSURE LINERS AS MANUFACTURED IN ALFELD, GERMANY AND UBON RATCHATHANI,
THAILAND FOR MEYER SEALS, ALFELDER KUNSTOFFWERKE HERM. MEYER GMBH.
27201 A II 7/5/2013 APOTEX PHARMACHEM INDIA PVT LTD SAXAGLIPTIN HCI WITH MANNITOL COPRECIPITATE 20% AS MANUFACTURED IN
BANGALORE, INDIA
27202 A II 6/27/2013 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
TACROLIMUS (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27203 A IV 6/5/2013 FONA INTERNATIONAL INC 915.0213U N-C FRESH STRAWBERRY FLAVOR, ART AS MANUFACTURED IN GENEVA,
ILLINOIS
27204 A II 6/17/2013 AARTI INDUSTRIES LTD BUPROPION HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27205 A II 6/15/2013 MSN LABORATORIES PVT LTD UNIT II BENDAMUSTINE HYDROCHLORIDE [ROUTE CODE - "BH"] AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27206 A II 6/21/2013 MSN PHARMACHEM PVT LTD AGOMELATINE [ROUTE CODE - "AG1"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27207 A II 6/10/2013 SHANGHAI SHYNDEC PHARMACEUTICAL
HAIMEN CO LTD
ZIDOVUDINE AS MANUFACTURED IN JIANGSU, CHINA
27208 A II 7/12/2013 RHODES TECHNOLOGIES INC METHYLPHENIDATE HCL USP (ESUB) AS MANUFACTURED IN COVENTRY, RI
27209 A II 7/1/2013 ALAND JIANGSU NUTRACEUTICAL CO LTD ASCORBIC ACID, USP, PH. EUR (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27210 A II 6/3/2013 SYMBIOTICA SPECIALITY INGREDIENTS SDN
BHD
BETHAMETHASONE VALERATE AS MANUFACTURED IN KEDAH, MALAYSIA
27211 A II 6/28/2013 DR REDDYS LABORATORIES LTD CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 820
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27212 A II 6/28/2013 DR REDDYS LABORATORIES LTD SAXAGLIPTIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27213 A II 9/12/2013 DR REDDYS LABORATORIES LTD TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYANO-2-AZABICYCLO[3.1.0]HEXAN-2-YL)1-((1R, 3R,5R,7S)-
3-HYDROXYADAMANTAN-1-YL)-2-OXOETHYL)CARBAMATE (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27214 A II 6/20/2013 MSN PHARMACHEM PVT LTD APREPITANT [ROUTE CODE - "AP2"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27215 A II 6/12/2013 AMBIOPHARM INC LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH
AUGUSTA, SC
27216 A II 7/1/2013 CHUNGHWA CHEMICAL SYNTHESIS AND
BIOTECH CO LTD
EVEROLIMUS (ESUB) AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN
27217 A II 6/14/2013 SCINOPHARM TAIWAN LTD BIMATOPROST AS MANUFACTURED IN TAINAN, TAIWAN
27218 A II 6/26/2013 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
PNEUMOCANDIN B0 (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27219 A II 7/9/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD OLANZAPINE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
27220 A III 6/17/2013 CILICANT CHEM PRIVATE LTD DESICCANT POUCH AS MANUFACTURED IN PUNE, INDIA
27221 A III 7/1/2013 COSPACK PLASTICS PRODUCTS CO LTD LAMINATE TUBES & COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL PACKAGING
AS MANUFACTURED IN GUANGDONG, CHINA
27222 A II 9/6/2013 ALP PHARM BEIJING CO LTD CALCIPOTRIENE HYDRATE (ESUB) AS MANUFACTURED IN LIAONING, CHINA FOR ALP
PHARM BEIJING CO., LTD
27223 A II 6/29/2013 EMCURE PHARMACEUTICALS LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27224 A II 6/29/2013 EMCURE PHARMACEUTICALS LTD PERPHENAZINE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27225 A II 6/15/2013 SHANGHAI SINE PHARMACEUTICAL
LABORATORIES CO LTD
RABEPRAZOLE SODIUM AS MANUFACTURED IN SHANGHAI, CHINA
27226 A IV 6/18/2013 EVONIK CORP POLY(D, L-LACTIDE CO-CAPROLACTONE) AND POLY(L-LACTIDE-CO-CAPROLACTONE) AS
MANUFACTURED IN BIRMINGHAM, AL
27227 A III 6/11/2013 AMPACET CORP 466276-KQ MYLAN BLUE SLIP 276 AS MANUFACTURED IN RAYONG, THAILAND FOR
AMPACET CORPORATION
27228 A III 6/11/2013 AMPACET CORP 111343 BLUE WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
27229 A II 6/4/2013 HEBEI HUARONG PHARMACEUTICAL CO LTD HYDROXOCOBALAMIN ACETATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA
27230 A II 6/27/2013 INTAS PHARMACEUTICALS LTD PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27231 A II 6/19/2013 HETERO LABS LTD SIMVASTATIN, USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27232 A II 6/19/2013 HETERO LABS LTD PRALATREXATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27233 A II 7/30/2013 CADILA HEALTHCARE LTD LINEZOLID (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27234 A II 7/9/2013 AUROBINDO PHARMA LTD MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
27235 A II 6/11/2013 YONSUNG FINE CHEMICALS CO LTD ISOPROPYL UNOPROSTONE AS MANUFACTURED IN GYEONGGI-DO, REPUBLIC OF
KOREA
27236 A III 6/18/2013 COGENT GLASS LTD MOULDED GLASS VIALS USP TYPE-I AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27237 A III 6/18/2013 COGENT GLASS LTD TUBULAR GLASS VIALS AND AMPOULES USP TYPE-I AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27238 A III 6/21/2013 BESPAK DIV CONSORT MEDICAL PLC BK640 GENERIC ORAL INTEGRATED DOSE COUNTER AS MANUFACTURED IN NORFOLK,
ENGLAND
Page 821
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27239 A II 6/29/2013 MSN PHARMACHEM PVT LTD SAXAGLIPTIN HYDROCHLORIDE [ROUTE CODE - "SH"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27240 A II 6/29/2013 MSN LABORATORIES PVT LTD VIGABATRIN USP - [ROUTE CODE - "VB"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27241 A II 9/27/2013 IPCA LABORATORIES LTD PROMETHAZINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA
PRADESH, INDIA
27242 A II 7/23/2013 LUPIN LTD PITAVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
27243 A II 6/18/2013 SICHUAN DEEBIO PHARMACEUTICALS CO.,
LTD.
HEPARIN SODIUM AS MANUFACTURED IN GUANGHAN CITY, P. R. CHINA
27244 A II 7/23/2013 CIPLA LTD MOMETASONE FUROATE MONOHYDRATE (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27245 A II 7/25/2013 IPCA LABORATORIES LTD MESALAMINE USP (MZ3 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
27246 A II 6/28/2013 JUBILANT LIFE SCIENCES LTD TADALAFIL-USP (ESUB) AS MANUFACTURED IN MYSORE, INDIA
27247 A II 6/25/2013 TIANJIN SEGA PHARMA CO LTD LAMIVUDINE USP AS MANUFACTURED IN TIANJIN, P.R. CHINA
27248 A II 6/4/2013 THE UNITED LABORATORIES INNER
MONGOLIA CO LTD
6-AMINO-PENICILLANIC ACID (6-APA) BULK DRUG SUBSTANCE AS MANUFACTURED IN
INNER MANGOLIA, P.R. CHINA
27249 A IV 6/4/2013 DMV FONTERRA EXCIPIENTS GMBH CO KG MICROCRYSTALINE CELLULOSE (SPRAY DRIED) AS MANUFACTURED IN GOCH,
GERMANY
27250 A II 6/21/2013 CEDARBURG PHARMACEUTICALS INC FLUOXYMESTERONE ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN GRAFTON,
WISCONSIN
27251 A II 9/17/2013 CADILA HEALTHCARE LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II) (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
27252 A II 7/17/2013 IPCA LABORATORIES LTD RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP (ESUB) AS MANUFACTURED IN
MADHYA PRADESH, INDIA
27253 A II 7/24/2013 MYLAN LABORATORIES LTD RILPIVIRINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN HYDERABAD, INDIA
27254 P *** PENDING FILING REVIEW ***
27255 A II 7/16/2013 HETERO DRUGS LTD PITAVASTATIN CALCIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27256 A II 9/20/2013 JUBILANT LIFE SCIENCES LTD VORICONAZOLE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
27257 A II 9/28/2013 JUBILANT LIFE SCIENCES LTD PALIPERIDONE PALMITATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
27258 A II 7/15/2013 NANJING LIFENERGY R AND D CO LTD IRON SUCROSE (ESUB) AS MANUFACTURED IN JIANGSU, P. R. CHINA FOR NANJING
LIFENERGY R&D CO LTD
27259 A II 7/15/2013 AMINO CHEMICALS LTD ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN MARSA, MALTA
27260 A II 7/29/2013 APICORE LLC PRIMAQUINE PHOSPHATE, USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR
APICORE LLC
27261 A II 6/21/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
CARBAMAZEPINE PROCESS B (VERSION NO.: 1) AS MANUFACTURED IN TAIZHOU CITY,
CHINA
27262 A IV 6/21/2013 NITIKA PHARMACEUTICAL SPECIALITIES
PVT LTD
CALCIUM STEARATE USP/NF AS MANUFACTURED IN MAHARASHTRA, INDIA
27263 A III 6/12/2013 PEARL POLYMERS LTD PET BOTTLES FOR PHARMACEUTICALS AS MANUFACTURED IN HIMACHAL PRADESH,
INDIA
27264 A III 6/14/2013 ROBIN INDUSTRIES INC EY-111206 AS MANUFACTURED IN BERLIN, OH FOR ROBIN INDUSTRIES, INC
27265 A II 6/25/2013 HYBIO PHARMACEUTICAL CO LTD NESIRITIDE CITRATE, NON-STERILE BULK DRUG SUBSTANCE GUANGDONG, P.R. CHINA
27266 A II 7/8/2013 ZHEJIANG HISOAR PHARMACEUTICAL CO
LTD
CLINDAMYCIN HYDROCHLORIDE (PROCESS B) AS MANUFACTURED IN TAIZHOU CITY,
P.R. CHINA
Page 822
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27267 A IV 6/28/2013 KRATON POLYMERS US LLC DX401 JS STYRENE-ISOPRENE-STYRENE COPOLYMER AS MANUFACTURED IN IBARAKI,
JAPAN FOR KRATON POLYMERS US LLC
27268 A II 7/2/2013 HETERO DRUGS LTD SAXAGLIPTIN HYDROCHLORIDE PREMIX AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27269 A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN CHENGDU,
P.R. CHINA
27270 A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD BOPET/VMPET/PE COMPOSITE FILM/BAG FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN CHENGDU, P.R. CHINA
27271 A II 7/15/2013 ZHEJIANG HISOAR PHARMACEUTICAL CO
LTD
CLINDAMYCIN PHOSPHATE (PROCESS B) AS MANUFACTURED IN TAIZHOU CITY, P.R.
CHINA
27272 A II 9/19/2013 NAVINTA LLC BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA FOR NAVINTA LLC
27273 A II 10/24/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275226] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
27274 A II 3/24/2014 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275268] (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL
27275 A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYVINYL CHLORIDE/POLYVINYLIDENE CHLORIDE (PVC/PVDC) COMPOSITE SHEET FOR
PACKAGING OF SOLID DOSAGE FORMS AS MANUFACTURED IN CHENGDU, P.R. CHINA
27276 A II 9/22/2013 ZHEJIANG HISOAR PHARMACEUTICAL CO
LTD
CLINDAMYCIN PALMITATE HYDROCHLORIDE (PROCESS B) AS MANUFACTURED IN
ZHEJIANG PROVINCE, P.R. CHINA
27277 A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYVINYL CHLORIDE (PVC) SHEET FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN CHENGDU, P.R. CHINA
27278 A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYAMIDE/ALUMINUM/POLYVINYL CHLORIDE (PA/AL/PVC) COLD FORMING COMPOSITE
SHEET FOR PACKAGING OF SOLID DOSAGE FORMS AS MANUFACTURED IN CHENGDU,
P.R. CHINA
27279 A III 6/27/2013 SICHUAN HUILI INDUSTRY., LTD. POLYESTER/ALUMINUM/CASTING POLYPROPYLENE (PET/AL/CPP) COMPOSITE FILM/BAG
FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN CHENGDU, P.R. CHINA
27280 A II 7/5/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
1-[2-AMINO-1-(4-METHOXYPHENYL) ETHYL] CYCLOHEXANOL HYDROCHLORIDE (VERSION
NO.:1) AS MANUFACTURED IN TAIZHOU CITY, CHINA
27281 A III 7/3/2013 TRUDELL MEDICAL INTERNATIONAL TOP MOUNTED ACTUATION INDICATOR (TMAI) - P/N 102545 AS MANUFACTURED IN
ONTARIO, CANADA
27282 A II 10/24/2013 GLAND PHARMA LTD INDOMETHACIN SODIUM USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27283 A III 5/9/2013 ALPHA PHARMA DAMAN PRIVATE LTD PET BOTTLES AS MANUFACTURED IN DAMAN, INDIA
27284 A II 7/16/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
FROVATRIPTAN SUCCINATE MONOHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA FOR BIOPHORE INDIA PHARMACEUTICALS PVT. LTD
27285 A II 12/31/2013 LUPIN LTD ASENAPINE MALEATE (MICRONIZED) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA FOR LUPIN LTD
27286 A II 8/26/2013 UNICHEM LABORATORIES LTD TIAGABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN RAIGAD, INDIA
27287 A II 8/20/2013 UNICHEM LABORATORIES LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN RAIGAD, INDIA
27288 A III 6/28/2013 AMPACET CORP 7011641 AB PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DEFIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
27289 A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYESTER/ALUMINUM/POLYETHYLENE (PET/AL/PE) COMPOSITE FILM/BAG FOR
PHARMACEUTICAL PACKAGING AS MANUFACTURED IN CHENGDU, P.R. CHINA
27290 A II 7/8/2013 CHEMO IBERICA SA ASENAPINE MALEATE AS MANUFACTURED IN MADRID, SPAIN
27291 A II 7/8/2013 SHISEIDO CO LTD SHISEIDO SODIUM HYALURONATE SZE GRADE-EP AS MANUFACTURED IN SHIZUOKA,
JAPAN
Page 823
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27292 A II 6/30/2013 MEGAFINE PHARMA P LTD ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27293 A II 7/3/2013 FARMABIOS SPA TIROFIBAN HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GROPELLO
CAIROLI (PAVIA), ITALY
27294 A IV 7/5/2013 LIPOID GMBH LIPOID PG 14:0/14:0 NH4 (DMPG-NH4) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY
27295 A II 7/10/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
27296 A III 6/28/2013 TIANJIN BOKELIN MEDICAL PACKAGING
TECHNOLOGY CO LTD
G60T-002 AS MANUFACTURED IN TIANJIN, P.R. CHINA
27297 A II 7/19/2013 3D IMAGING DRUG DESIGN AND
DEVELOPMENT LLC
FLUOROMISONIDAZOLE F 18 INJECTION (ESUB) AS MANUFACTURED IN LITTLE ROCK, AR
27298 A II 8/23/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD PRALATREXATE (ESUB) AS MANUFACTURED IN MILAN, ITALY AND OPAVA - KOMAROV
CZECH REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
27299 P *** PENDING FILING REVIEW ***
27300 A II 8/8/2013 SIGMAPHARM LABORATORIES LLC AMORPHOUS ASENAPINE MALEATE (ESUB) AS MANUFACTURED IN BENSALEM, PA
27301 A II 10/1/2013 3D IMAGING DRUG DESIGN AND
DEVELOPMENT LLC
DPA-713 I 124 INJECTION (ESUB) AS MANUFACTURED IN LITTLE ROCK, ARKANSAS
27302 A II 7/29/2013 AUROBINDO PHARMA LTD ARMODAFINIL (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27303 A II 9/27/2013 GLENMARK GENERICS LTD EZETIMIBE (D067 PROCESS) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27304 A III 7/1/2013 LORMAC INDUSTRIAL DISTRIBUTORS LTD LRMAC TYPE 3A POLYETHYLENE AS MANUFACTURED IN FORGE HILL, CORK IRELAND
27305 A IV 7/8/2013 UNGERER AND CO ARTIFICIAL JUICY RASPBERRY FLAVOR FW-4870 AS MANUFACTURED IN BETHLEHEM, PA
27306 A II 7/10/2013 NERPHARMA SRL MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN NERVIANO
MILAN, ITALY
27307 A II 7/26/2013 MSN LABORATORIES PVT LTD UNIT II LATANOPROST USP [ROUTE CODE LO ] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27308 A II 7/31/2013 MSN LABORATORIES PVT LTD UNIT II DOCETAXEL ANHYDROUS USP [ROUTE CODE - DL] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27309 A II 7/30/2013 MSN PHARMACHEM PVT LTD SAXAGLIPTIN MONOHYDRATE [ROUTE CODE - SC] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INIDA
27310 A II 7/26/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD GEFITINIB (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
27311 A II 9/9/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DOXORUBICIN HYDROCHLORIDE USP (FERMENTATION) (ESUB) AS MANUFACTURED IN
TAIZHOU CITY, CHINA
27312 A II 9/24/2013 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
ORLISTAT (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27313 A II 10/8/2013 ACS DOBFAR SPA NAFCILLIN SODIUM FOR INJECTION (STERILE BULK) (ESUB) AS MANUFACTURED IN
MILANO, ITALY
27314 A II 7/26/2013 TRIS PHARMA INC COD-CPM ER ORAL SUSPENSION (ESUB) AS MANUFACTURED IN MONMOUTH
JUNCTION, NJ
27315 P *** PENDING FILING REVIEW ***
27316 A II 7/26/2013 SIGNA SA DE CV ASENAPINE MALEATE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO
27317 A III 7/11/2013 LEVOSIL SPA CLAY DESICCANT BAGS TYPE A AS MANUFACTURED IN TURIN, ITALY
27318 A III 7/11/2013 LEVOSIL SPA 100% COBALT FREE HUMIDITY INDICATOR CARDS AS MANUFACTURED IN TURIN, ITALY
27319 A II 7/16/2013 CHUNG JIN BIOTECH CO LTD ISOLATED AND PURIFIED BEEVENOM AS MANUFACTURED IN GYEONGGI-DO, KOREA Page 824
4Q2012 2Q2014EXCEL
27320 A V 8/20/2013 MECKESSON SPECIALTY HEALTH TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) ACCESS PROGRAM (ESUB)
27321 A II 7/8/2013 CHUNG JIN BIOTECH CO LTD PURIFIED BEEVENOM AS MANUFACTURED IN GYEONGGI-DO, KOREA
27322 A II 3/4/2014 COSMA SPA DICLOFENAC HYDROXY ETHYL PYRROLIDINE (ESUB) AS MANUFACTURED IN CISERANO
(BERGAMO), ITALY
27323 A III 7/17/2013 ST GOBAIN PERFORMANCE PLASTICS NORTON ETFE E4 CT-1S AS MANUFACTURED IN WAYNE, NJ
27324 A II 7/2/2013 JSR LIFE SCIENCES CORP AMSPHERE PROTEIN A JWT203 AS MANUFACTURED IN IBARAKI, JAPAN
27325 A II 7/19/2013 FARMABIOS SPA METHYLPREDNISOLONE ACETATE STERILE AS MANUFACTURED IN GROPELLO CAIROLI
(PV), ITALY
27326 A III 7/15/2013 SENXING PHARMACEUTICAL CONSUMABLE
BEIJING LTD
RUBBER DISC AS MANUFACTURED IN BEIJING, P.R. CHINA
27327 A III 7/18/2013 REXAM HEALTHCARE OFFRANVILLE SAS NASONEX BOTTLES AND CAPS AS MANUFACTURED IN OFFRANVILLE, FRANCE
27328 A III 7/22/2013 WATSON MARLOW LTD BIOPRENE THERMOPLASTIC ELASTOMER TUBING AS MANUFACTURED IN CORNWALL,
ENGLAND
27329 A IV 7/22/2013 FONA INTERNATIONAL INC 884.038 N-C ORANGE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
27330 A IV 7/22/2013 FONA INTERNATIONAL INC 862.0428U N-C LEMON FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL
27331 A II 11/5/2013 TARO PHARMACEUTICAL INDUSTRIES LTD FELBAMATE USP (ESUB) AS MANUFACTURED IN HAIFA, ISRAEL
27332 N NOT AN ASSIGNED NUMBER
27333 A II 7/31/2013 CADILA HEALTHCARE LTD PITAVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27334 A II 5/13/2013 ALLIANCE ENZYME PVT LTD PAPAIN (LIQUID) AS MANUFACTURED IN GUJARAT, INDIA
27335 P *** PENDING FILING REVIEW ***
27336 A II 9/27/2013 JIANGSU HENGRUI MEDICINE CO LTD FONDAPARINUX SODIUM (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27337 A III 7/17/2013 WITTENBURG B.V. CAWITON MO SERIES FOR MEDICAL & PHARMACEUTICAL USE AS MANUFACTURED IN
ZEEWOLDE, NETHERLANDS
27338 A III 7/24/2013 WITTENBURG B.V. CAWITON MT-SERIES FOR MEDICAL & PHARMACEUTICAL APPLICATIONS AS
MANUFACTURED IN ZEEWOLDE, NETHERLANDS
27339 A II 7/18/2013 POLYMED THERAPEUTICS INC CABAZITAXEL ETHYL ACETATE SOLVATE DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, CHINA
27340 A II 9/20/2013 FIS FABBRICA ITALIANA SINTETICI SPA PRASTERONE ACETATE (ESUB) AS MANUFACTURED IN VICENZA, ITALY
27341 N NOT AN ASSIGNED NUMBER
27342 A III 7/24/2013 DITTA INDIVIDUALE PAOLO GOBBI FRATTINI PLASTIC BAGS FOR PHARMACEUTICAL SOLUTIONS AND THEIR COMPONENTS AS
MANUFACTURED IN SONDRIO, ITALY
27343 A IV 7/25/2013 KERRY BIOFUNCTIONAL INGREDIENTS INC LUBRITOSE MANNITOL AS MANUFACTURED IN NORWICH, NY
27344 N NOT AN ASSIGNED NUMBER
27345 A III 7/10/2013 SCORPION CONTAINERS PRIVATE LTD FLIP OFF SEALS AS MANUFACTURED IN GUJARAT, INDIA
27346 A III 7/10/2013 SCORPION CONTAINERS PRIVATE LTD ROPP CAPS AS MANUFACTURED IN GUJARAT, INDIA
27347 A II 9/3/2013 RUBICON RESEARCH PVT LTD COATED DEXTROMETHORPHAN POLISTIREX (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27348 A II 9/24/2013 ORCHID CHEMICALS AND
PHARMACEUTICALS LTD
ERTAPENEM SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27349 N NOT AN ASSIGNED NUMBER
27350 A II 8/14/2013 BAL PHARMA LTD BEPOTASTINE BESILATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
27351 N NOT AN ASSIGNED NUMBER
27352 A II 7/15/2013 SUNBIO INC METHOXY POLYETHYLENE GLYCOL AMINE 2,000 AS MANUFACTURED IN ANYANG CITY,
S.KOREA
Page 825
4Q2012 2Q2014EXCEL
27353 A II 7/29/2013 DSM SINOCHEM PHARMACEUTICALS
NETHERLANDS BV
PNEUMOCANDIN B0 AS MANUFACTURED IN SHANGHAI, P.R. CHINA FOR DSM SINOCHEM
PHARMACEUTICALS NETHERLANDS B.V.
27354 A II 7/29/2013 HETERO DRUGS LTD PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27355 A III 7/31/2013 JIANGSU HUALAN NEW PHARMACEUTICAL
MATERIAL CO LTD
HALOGENATED BUTYL RUBBER COMPONENTS AS MANUFACTURED IN JIANGYIN
LINGANG NEW CITY, CHINA
27356 A III 7/17/2013 AMPACET CORP 1000071-N AS PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA,
CARTERSVILLE, GA AND HEATH, OH
27357 A IV 4/23/2013 GC CHEMIE PHARMIE LTD NOVODONE - CR CROSPOVIDONE USP-NF AS MANUFACTURED IN QUZHOU, P.R. CHINA
FOR G.C. CHEMIE PHARMIE LTD.
27358 A IV 4/23/2013 GC CHEMIE PHARMIE LTD NOVODONE PROVIDONE USP-35 AS MANUFACTURED IN QUZHOU, P.R. CHINA FOR G.C.
CHEMIE PHARMIE LTD.
27359 A III 7/29/2013 3M DRUG DELIVERY SYSTEMS 25 UL VALVE A66060 AS MANUFACTURED IN LANCASHIRE, GREAT BRITAIN FOR 3M DRUG
DELIVERY SYSTEMS
27360 N NOT AN ASSIGNED NUMBER
27361 N NOT AN ASSIGNED NUMBER
27362 N NOT AN ASSIGNED NUMBER
27363 A II 8/1/2013 CHONGQING HUAPONT PHARMACEUTICAL
CO LTD
CALCIPOTRIOL ANHYDROUS AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR
CHONGQING HUAPONT PHARMACEUTICAL CO., LTD.
27364 A II 8/22/2013 AUROBINDO PHARMA LTD CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27365 N NOT AN ASSIGNED NUMBER
27366 A II 9/18/2013 DK PHARMA CHEM PVT LTD PROBENECID (PBX) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27367 A II 7/31/2013 CHONGQING HUAPONT PHARMACEUTICAL
CO LTD
CALCIPOTRIOL MONOHYDRATE AS MANUFACTURED IN CHONGQING, P.R. CHINA FOR
CHONGQING HUAPONT PHARMACEUTICAL CO., LTD.
27368 N NOT AN ASSIGNED NUMBER
27369 A II 7/31/2013 APTALIS PHARMATECH INC APT-5020 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA, OHIO
27370 A II 8/30/2013 MYLAN LABORATORIES LTD ROTIGOTINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27371 N NOT AN ASSIGNED NUMBER
27372 N NOT AN ASSIGNED NUMBER
27373 A II 7/31/2013 BLOOMAGE FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-E 2.0) AS MANUFACTURED IN JINAN CITY, P.R. OF CHINA
27374 N NOT AN ASSIGNED NUMBER
27375 A II 7/31/2013 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
PANTOPRAZOLE SODIUM AS MANUFACTURED IN SHOUGUANG CITY, CHINA
27376 A II 8/1/2013 OLON SPA ABIRATERONE ACETATE AS MANUFACTURED IN MILANO, ITALY
27377 N NOT AN ASSIGNED NUMBER
27378 A II 9/16/2013 PAR PHARMACEUTICAL INC ALOSETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA FOR
PAR PHARMACEUTICAL, INC
27379 A II 9/17/2013 MYLAN LABORATORIES LTD CLOZAPINE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27380 A II 12/20/2013 SIGNA SA DE CV TIAGABINE HYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN ESTADO DE
MEXICO, MEXICO
27381 A II 8/23/2013 SUZHOU HOMESUN PHARMACEUTICAL CO
LTD
CEFMETAZOLE SODIUM AS MANUFACTURED IN TAICANG CITY, CHINA FOR CHENGDU
JUNXIANG PHARMACEUTICAL TECHNOLOGY CO., LTD
27382 A II 9/23/2013 CADILA HEALTHCARE LTD ARSENIC TRIOXIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27383 A II 8/1/2013 FARCHEMIA SRL SECNIDAZOLE AS MANUFACTURED IN TREVIGLIO, ITALY
Page 826
4Q2012 2Q2014EXCEL
27384 P *** PENDING FILING REVIEW ***
27385 A II 9/10/2013 ZHEJIANG CHANGMING PHARMACEUTICAL
CO LTD
LISINOPRIL DIHYDRATE USP (NON-STERILE) (ESUB) AS MANUFACTURED IN TIANTAI,
CHINA
27386 A II 8/16/2013 BAL PHARMA LTD BEPOTASTINE BESILATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA FOR BAL
PHARMA LIMITED.
27387 I II 8/29/2013 APTUIT SCIENTIFIC OPERATIONS INC SODIUM PHENYLACETATE AS MANUFACTURED IN KANSAS CITY, MO FOR APTUIT SCIENTIFIC OPERATIONS, LLC.
27388 A II 8/22/2013 EMCURE PHARMACEUTICALS LTD ESOMEPRAZOLE SODIUM (PROCESS II) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
27389 N NOT AN ASSIGNED NUMBER
27390 A II 8/30/2013 EMCURE PHARMACEUTICALS LTD PROPOFOL USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27391 N NOT AN ASSIGNED NUMBER
27392 N NOT AN ASSIGNED NUMBER
27393 N NOT AN ASSIGNED NUMBER
27394 A II 8/7/2013 YICHANG CHANGJIANG PHARMACEUTICAL
CO LTD
MOXIFLOXACIN HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN YIDU CITY, P.R. CHINA
27395 A II 8/1/2013 SHANDONG RENHETANG PHARMACEUTICAL
CO LTD
DIFENIDOL HYDROCHLORIDE AS MANUFACTURED IN LINYI, CHINA
27396 N NOT AN ASSIGNED NUMBER
27397 N NOT AN ASSIGNED NUMBER
27398 A II 7/30/2013 CHONGQING HUAPONT PHARMACEUTICAL
CO LTD
TRETINOIN AS MANUFACTURED IN CHONGQING P. R. CHINA FOR CHONGQING HUAPONT
PHARMACEUTICAL CO., LTD
27399 A II 11/1/2013 CONCORD BIOTECH LTD ROMIDEPSIN (ESUB) AS MANUFACTURED IN AHMEDABAD, INDIA
27400 A II 9/25/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD ROMIDEPSIN (ESUB) AS MANUFACTURED IN MILAN, ITALY FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
27401 A II 8/31/2013 AUROBINDO PHARMA LTD ENTECAVIR (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27402 A II 2/20/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS) (ESUB) AS
MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
27403 A II 9/1/2013 ALKEM LABORATORIES LTD RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27404 A IV 5/24/2013 EVONIK INDUSTRIES AG WERK ROHEM EUDRAGIT RL/RS AS MANUFACTURED IN DARMSTADT, GERMANY
27405 A II 1/2/2014 NAVINTA LLC SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR NAVINTA
LLC
27406 A II 8/2/2013 JARI PHARMACEUTICAL CO LTD TORSEMIDE AS MANUFACTURED IN JIANGSU, CHINA
27407 A II 7/31/2013 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA HIC AS MANUFACTURED IN AJDOVSCINA,
SLOVENIA
27408 A III 8/8/2013 PARAS ENTERPRISE ALUMINIUM FOILS AS MANUFACTURED IN GUJARAT, INDIA
27409 A IV 8/9/2013 NB ENTREPRENEURS MICROCRYSTALLINE CELLULOSE USP OF VARIOUS GRADES AS MANUFACTURED IN
MAHARASHTRA, INDIA
27410 A II 8/1/2013 MURLI KRISHNA PHARMA PVT LTD ITRACONAZOLE PELLETS 22.0 % W/W AS MANUFACTURED IN MAHARASHTRA, INDIA
27411 A II 8/1/2013 MURLI KRISHNA PHARMA PVT LTD OMEPRAZOLE PELLETS 8.5 % W/W AS MANUFACTURED IN MAHARASHTRA, INDIA
27412 A II 8/1/2013 MURLI KRISHNA PHARMA PVT LTD CLARITHROMYCIN PELLETS 42.0 % W/W AS MANUFACTURED IN MAHARASHTRA, INDIA
27413 A II 8/1/2013 MURLI KRISHNA PHARMA PVT LTD LANSOPRAZOLE PELLETS 8.5 % W/W AS MANUFACTURED IN MANHARASHTRA, INDIA
27414 A III 7/26/2013 PRETIUM PACKAGING LLC PLASTIC PACKAGING MATERIAL AS MANUFACTURED IN HAZLETON, PA
27415 A IV 8/2/2013 UNGERER AND CO NATURAL AND ARTIFICIAL MENTHOL FLAVOR FP-4594 AS MANUFACTURED IN
BETHLEHEM, PA
Page 827
4Q2012 2Q2014EXCEL
27416 A III 8/9/2013 AMERICAN TECHNICAL MOLDING INC MOLDED PLASTIC COMPONENTS AS MANUFACTURED IN CLEARWATER, FL
27417 A IV 8/14/2013 QUZHOU JIANHUA NANHANG INDUSTRIAL
CO LTD
POVIDONE K30 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27418 A II 8/13/2013 NEULAND LABORATORIES LTD PROPOFOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27419 A II 8/12/2013 AVESTA PHARMA PVT LTD POLYETHYLENE GLYCOL NF AS MANUFACTURED IN MAHARASHTRA, INDIA
27420 A II 8/24/2013 MSN LABORATORIES PVT LTD UNIT II EPOPROSTENOL SODIUM [ROUTE CODE - ED] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27421 A II 8/26/2013 MSN PHARMACHEM PVT LTD DARUNAVIR ETHANOLATE [ROUTE CODE DN] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27422 A II 8/31/2013 MSN LABORATORIES PVT LTD PAZOPANIB HYDROCHLORIDE [ROUTE CODE - "PY"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27423 A II 8/26/2013 HUBEI GEDIAN HUMANWELL
PHARMACEUTICAL CO LTD
16A-HYDROXYPREDNISOLONE (ESUB) AS MANUFACTURED IN E-ZHOU CITY, P. R. OF
CHINA
27424 A II 8/14/2013 BELLICUM PHARMACEUTICALS INC AP1903 DRUG SUBSTANCE AS MANUFACTURED IN ONTARIO, CANADA FOR BELLICUM
PHARMACEUTICALS, INC.
27425 A III 8/8/2013 PACK MATES PACKAGING INDIA PRIVATE
LTD
FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN HYBERABAD, INDIA
27426 A III 7/26/2013 YANGZHOU JEREL PACKING MATERIAL CO.,
LTD
PA/AL/PVC COLD- FORMED FOIL FOR SOLID PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN YANGZHOU CITY, CHINA
27427 P *** PENDING FILING REVIEW ***
27428 A II 3/13/2014 DK PHARMA CHEM PVT LTD TRIMETHOBENZAMIDE HYDROCHLORIDE (TBZ) (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27429 A II 7/18/2013 AVRA LABORATORIES PRIVATE LTD 7-ETHYL-10-HYDROXYCAMPTOTHECIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27430 A II 7/23/2013 SHANDONG XINHUA PHARMACEUTICAL CO
LTD
CARBIDOPA AS MANUFACTURED IN SHANDONG, P.R. CHINA
27431 A II 8/2/2013 ZHEJIANG XIANJU PHARMACEUTICAL CO
LTD
TESTOSTERONE ENANTHATE, NON-STERILE BULK DRUG SUBSTANCE AS
MANUFACTURED IN ZHEJIANG, CHINA
27432 A II 9/12/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD BORTEZOMIB (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA
27433 A II 9/27/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DOCETAXEL TRIHYDRATE USP (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE,
CHINA
27434 A II 8/29/2013 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
FR179642 (ESUB) AS MANUFACTURED ZHEJIANG PROVINCE, CHINA
27435 A II 9/25/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MICAFUNGIN SODIUM (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27436 A II 8/14/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
DARUNAVIR AS MANUFACTURED IN ZHEJIANG, CHINA
27437 A II 8/14/2013 JOST CHEMICAL CO SODIUM PHOSPHATE DIBASIC DIHYDRATE AS MANUFACTURED IN ST. LOUIS, MO
27438 A II 8/10/2013 RUYUAN HEC PHARM CO LTD SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
GUANGDONG PROVINCE, P.R. CHINA
27439 A II 9/30/2013 ALEMBIC PHARMACEUTICALS LTD TOPIRAMATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA
27440 A II 8/15/2013 YICHANG CHANGJIANG PHARMACEUTICAL
CO LTD
INSULIN HUMAN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU
CITY, P.R. CHINA
27441 A II 9/26/2013 QILU PHARMACEUTICAL CO LTD CABAZITAXEL AS MANUFACTURED IN SHANDONG P. R. CHINA FOR QILU
PHARMACEUTICAL CO., LTD
Page 828
4Q2012 2Q2014EXCEL
27442 A II 9/13/2013 CIPLA LTD GEMCITABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
27443 A II 12/3/2013 GLENMARK GENERICS LTD LINEZOLID D111 PROCESS (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27444 A II 11/20/2013 WISDOM PHARMCEUTICAL CO LTD ENTECAVIR (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27445 A III 8/19/2013 SENSOPLAST PACKMITTELTECHNIK GMBH CONTAINER CLOSURE SYSTEMS AS MANUFACTURED IN OBERHONNEFELD, GERMANY
27446 A II 11/15/2013 UNIQUE CHEMICALS CILNIDIPINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27447 A II 10/14/2013 SUN PHARMACEUTICAL INDUSTRIES LTD TESTOSTERONE USP (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
27448 A II 9/10/2013 MICRO LABS LTD RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
27449 A III 8/16/2013 GREEN PACK FOILS PRIVATE LTD PET-FOIL-POLY LAMINATES AS MANUFACTURED IN GUJARAT, INDIA
27450 A III 8/10/2013 GREEN PACK FOILS PRIVATE LTD COLD FORMING BLISTER (ALU-ALU) LAMINATE AS MANUFACTURED IN GUJARAT, INDIA
27451 A II 11/1/2013 APOTEX PHARMACHEM INC BUDESONIDE USP AS MANUFACTURED IN ONTARIO, CANADA
27452 A II 9/20/2013 GLENMARK GENERICS LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27453 A II 8/20/2013 ZHEJIANG CHARIOTEER PHARMACEUTICAL
CO LTD
VALACYCLOVIR HYDROCHLORIDE ANHYDROUS FORM I AS MANUFACTURED IN
ZHEJIANG PROVINCE, P. R. CHINA
27454 A II 9/25/2013 MYLAN LABORATORIES LTD EFAVIRENZ USP (PROCESS-III) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27455 A II 9/24/2013 MYLAN LABORATORIES LTD EMTRICITABINE (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27456 A II 9/24/2013 MYLAN LABORATORIES LTD TENOFOVIR DISOPROXIL FUMARATE (PROCESS-II) (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27457 A II 8/31/2013 MSN LABORATORIES PVT LTD DOCETAXEL TRIHYDRATE USP [ROUTE CODE - "DO"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27458 A II 9/6/2013 CTX LIFE SCIENCES PVT LTD LEVETIRACETAM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27459 A V 11/22/2013 MEDIMMUNE LLC FACILITIES AND EQUIPMENT INFORMATION FOR THE MEDIMMUNE LLC, FREDERICK
MANUFACTURING CENTER
27460 P *** PENDING FILING REVIEW ***
27461 A II 3/31/2014 CIPLA LTD BUDESONIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27462 A II 9/27/2013 CIPLA LTD LOPINAVIR USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
27463 A II 9/29/2013 CADILA HEALTHCARE LTD PITAVASTATIN MAGNESIUM (ESUB) MANUFACTURED IN GUJARAT, INDIA
27464 A II 9/18/2013 IPCA LABORATORIES LTD MIDODRINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
27465 A II 8/27/2013 ICROM SPA BEPOTASTINE BESILATE AS MANUFACTURED IN CONCOREZZO, ITALY
27466 A II 8/26/2013 ASYMCHEM LABORATORIES TIANJIN CO LTD TAMOXIFEN CITRATE AS MANUFACTURED IN TIANJIN, CHINA
27467 A II 3/29/2014 FARMSON PHARMACEUTICAL GUJARAT
PRIVATE LTD
ACETAMINOPHEN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27468 A II 5/7/2014 CIVENTICHEM LLC SODIUM NITROPRUSSIDE USP (ESUB) AS MANUFACTURED IN CARY, NC
27469 A II 9/30/2013 CIVENTICHEM LLC ISOPROTERENOL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN CARY, NC
27470 A II 9/23/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
ALOSETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN VISAKHAPATNAM, INDIA
FOR BIOPHORE INDIA PHARMACEUTICALS PVT. LTD
27471 A III 12/13/2013 INDIAN OIL CORP LTD PROPEL PP2120MC (ESUB) AS MANUFACTURED IN HARYANA, INDIA
27472 A II 9/17/2013 RAKS PHARMA PVT LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27473 A II 9/3/2013 NEULAND LABORATORIES LTD ETHACRYNIC ACID USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 829
4Q2012 2Q2014EXCEL
27474 A II 9/13/2013 FORMOSA LABORATORIES INC MIFEPRISTONE (ESUB) AS MANUFACTURED IN TAOYUAN, TAIWAN
27475 A II 9/17/2013 FORMOSA LABORATORIES INC FONDAPARINUX SODIUM (ESUB) AS MANUFACTURED IN TAOYUAN, TAIWAN
27476 A III 8/15/2013 SSS PLASTICS PVT LTD BOTTLES AND CLOSURES AS MANUFACTURED IN GUJARAT, INDIA
27477 A II 8/19/2013 CHONGQING FUAN PHARMACEUTICAL
GROUP CO LTD
TIGECYCLINE AS MANUFACTURED IN CHANGSHOU, CHINA FOR CHONGQING FUAN
PHARMACEUTICAL (GROUP) CO., LTD.
27478 A II 8/28/2013 IMAX DIAGNOSTIC IMAGING HOLDING LTD IODIXANOL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR IMAX DIAGNOSTIC
IMAGING HOLDING LIMITED
27479 A II 9/27/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
TADALAFIL USP (ESUB) AS MANUFACTURED IN LINHAI, CHINA
27480 A III 8/22/2013 AMPACET CORP 469837 BLUE SMC PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA,
CARTERSVILLE, GA AND HEATH, OH
27481 P *** PENDING FILING REVIEW ***
27482 A II 9/29/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
THIAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
FOR BIOPHORE INDIA PHARMACEUTICALS PVT. LTD
27483 A II 9/20/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA FOR BIOPHORE INDIA PHARMACEUTICALS PVT LTD
27484 A II 9/27/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
ISOTRETINOIN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT LTD.
27485 A II 9/28/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
MELPHALAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
FOR BIOPHORE INDIA PHARMACEUTICALS PVT LTD
27486 A II 9/22/2013 YUNNAN HANDE BIO-TECH CO LTD 10-DAB SYNTHESIZED PACLITAXEL API MANUFACTURED IN KUNMING. P.R. CHINA
27487 A II 9/23/2013 SHILPA MEDICARE LTD AZACITIDINE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
27488 A II 9/26/2013 SHILPA MEDICARE LTD DECITABINE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
27489 A II 9/26/2013 SHILPA MEDICARE LTD LETROZOLE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
27490 P *** PENDING FILING REVIEW ***
27491 A II 9/27/2013 CTX LIFE SCIENCES PVT LTD SEVELAMER HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27492 A II 9/27/2013 CTX LIFE SCIENCES PVT LTD COLESEVELAM HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27493 P *** PENDING FILING REVIEW ***
27494 A II 9/25/2013 UNICHEM LABORATORIES LTD RANOLAZINE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
27495 A III 9/6/2013 MITSUBISHI GAS CHEMICAL CO INC OA RESIN AS MANUFACTURED IN KANAGAWA, JAPAN
27496 A II 9/23/2013 POLYCARBON INDUSTRIES INC DBA PCI
SYNTHESIS
PCI-104234 NON-STERILE BULK DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN
NEWBURYPORT, MA
27497 A II 9/3/2013 OLON SPA BEZAFIBRATE AS MANUFACTURED IN DORNO (PV) ,ITALY
27498 N NOT AN ASSIGNED NUMBER
27499 N NOT AN ASSIGNED NUMBER
27500 A II 9/30/2013 MALLINCKRODT INC DEXTROMETHADONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO
27501 A II 9/19/2013 AUROBINDO PHARMA LTD CELECOXIB USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27502 A II 9/19/2013 AUROBINDO PHARMA LTD ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27503 A II 9/24/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
PALIPERIDONE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27504 A II 9/19/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
PIOGLITAZONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27505 A II 9/30/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
AMBRISENTAN (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27506 A III 9/9/2013 AVERY DENNISON HP104 ADHESIVE AS MANUFACTURED IN KUNSHAN, CHINA
Page 830
4Q2012 2Q2014EXCEL
27507 N NOT AN ASSIGNED NUMBER
27508 A II 9/11/2013 GUANG'AN KINGDAY PHARMA AND CHEM CO
LTD
AZTREONAM USP AS MANUFACTURED IN SICHUAN PROVINCE, P.R. CHINA
27509 N NOT AN ASSIGNED NUMBER
27510 A II 9/11/2013 YANCHENG YOUHUA PHARMACEUTICAL
AND CHEMICAL TECHNOLOGY CO LTD
BACITRACIN USP AS MANUFACTURED IN YANCHENG, PEOPLES REPUBLIC OF CHINA
27511 P *** PENDING FILING REVIEW ***
27512 A II 9/21/2013 IPCA LABORATORIES LTD ETODOLAC USP (ED7 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
27513 A II 9/6/2013 CILAG AG REMIFENTANIL HCI DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN,
SWITZERLAND
27514 A II 10/10/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD PALIPERIDONE (ESUB) AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
27515 N NOT AN ASSIGNED NUMBER
27516 A II 9/30/2013 CADILA HEALTHCARE LTD RIVASTIGMINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27517 N NOT AN ASSIGNED NUMBER
27518 N NOT AN ASSIGNED NUMBER
27519 N NOT AN ASSIGNED NUMBER
27520 N NOT AN ASSIGNED NUMBER
27521 N NOT AN ASSIGNED NUMBER
27522 A IV 9/9/2013 THE DOW CHEMICAL CO AFFINISOL HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE AS
MANUFACTURED IN BOMLITZ, GERMANY FOR THE DOW CHEMICAL COMPANY
27523 N NOT AN ASSIGNED NUMBER
27524 A II 10/23/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD TIOTROPIUM BROMIDE (ESUB) AS MANUFACTURED IN RHO (MILAN) AND SANTHIA
(VERCELLY), ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
27525 A II 4/27/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD ATORVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN BE'ER SHEVA, ISRAEL AND
NETANYA, ISREAL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
27526 A IV 9/18/2013 NOVOZYMES AS SODIUM HYALURONATE FROM BACILLUS SUBTILIS (TOPICAL GRADE): HYASIS(R) 850T
(ESUB) AS MANUFACTURED IN TIANJIN, CHINA FOR NOVOZYMES AS
27527 A II 9/27/2013 SANDOZ GMBH CEFIXIME AS MANUFACTURED IN KUNDL, AUSTRIA
27528 A II 9/27/2013 CIPLA LTD PALONOSETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27529 A III 8/29/2013 ROBIN INDUSTRIES INC EY-111214; USP CLASS VI APPROVED CHLOROBUTYL COMPOUND FOR SYRINGE TIP
APPLICATIONS AS MANUFACTURED IN BERLIN, OHIO FOR ROBIN INDUSTRIES INC.
27530 A III 9/4/2013 ROBIN INDUSTRIES INC I-5715; USP CLASS VI APPROVED POLYISOPRENE COMPOUND FOR PLUNGER TIP
APPLICATIONS AS MANUFACTURED IN BERLIN, OHIO FOR ROBIN INDUSTIRES INC
27531 A II 9/26/2013 STEROID SPA TESTOSTERONE UNDECANOATE (ESUB) AS MANUFACTURED IN COLOGNO, MONZESE
(MI), ITALY
27532 A II 9/21/2013 MACLEODS PHARMACEUTICALS LTD TROSPIUM CHLORIDE (ESUB) AS MANUFACTURED IN VALSAD, INDIA
27533 A II 9/29/2013 MACLEODS PHARMACEUTICALS LTD OSELTAMIVIR PHOSPHATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27534 A II 9/13/2013 AMOLI ORGANICS PVT LTD LINEZOLID [FORM-1] (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27535 A III 9/5/2013 ROBIN INDUSTRIES INC I-4318; USP CLASS VI APPROVED POLYISOPRENE COMPOUND FOR PLUNGER TIP
APPLICATIONS MANUFACTURED IN BERLIN, OHIO FOR ROBIN INDUSTRIES INC.
27536 A IV 9/12/2013 FREUND CORP NONPAREIL-105 AS MANUFACTURED IN HAMAMATSU CITY, JAPAN
27537 A III 9/11/2013 COIM USA INC NOVACOTE HS-8243 AS MANUFACTURED IN OFFANENGO,ITALY FOR COIM USA, INC
Page 831
4Q2012 2Q2014EXCEL
27538 A II 9/23/2013 MICRO LABS LTD TELMISARTAN USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
27539 A II 9/26/2013 MICRO LABS LTD OLMESARTAN MEDOXOMIL USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
27540 A III 9/10/2013 BOREALIS AG BORMED SB815MO AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG
27541 A V 10/18/2013 PFIZER INC MODULAR VIRAL CLEARANCE (ESUB)
27542 A III 9/13/2013 TAISEI KAKO CO LTD PLASTIC SYRINGES (VFP-ARD-5ML) AS MANUFACTURED IN IBARAKI CITY, JAPAN
27543 A II 9/27/2013 SCINOPHARM TAIWAN LTD DECITABINE AS MANUFACTURED IN JIANGSU, CHINA FOR SCINOPHARM TAIWAN, LTD.
27544 A II 9/9/2013 BIOSYN ARZNEIMITTEL GMBH SODIUM SELENITE PENTAHYDRATE AS MANUFACTURED IN FELLBACH, GERMANY
27545 A II 9/9/2013 BIOSYN ARZNEIMITTEL GMBH SELENIUM 5 MG TABLETS AS MANUFACTURED IN ENNIGERLOH, GERMANY FOR BIOSYN
ARZNEIMITTEL GMBH
27546 P *** PENDING FILING REVIEW ***
27547 A II 9/23/2013 AREVIPHARMA GMBH BUPRENORPHINE AS MANUFACTURED IN RADEBEUL, GERMANY
27548 A IV 12/17/2013 ASHLAND SPECIALITY INGREDIENTS GP AQUARIUS(TM) COATING SYSTEMS (ESUB) AS MANUFACTURED IN WILMINGTON, DE
27549 A III 9/10/2013 PRECIS PHARMA CONTAINERS PLASTIC CONTAINERS AND CLOSURES AS MANUFACTURED IN KARNATAKA, INDIA
27550 A II 9/30/2013 AUROBINDO PHARMA LTD SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27551 A II 9/30/2013 AUROBINDO PHARMA LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27552 A III 9/13/2013 POLYONE CORP CC1012852460 (PE LITE BLUE 278C) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
27553 A II 9/10/2013 OLON SPA ALITRETINOIN AS MANUFACTURED IN GARBAGNATE MILANESE (MI) , ITALY
27554 A II 9/13/2013 OLON SPA ROTIGOTINE POLYMORPH II AS MANUFACTURED RODANO (MI) , ITALY
27555 A III 9/17/2013 WEST PHARMACEUTICAL SERVICES INC NOVAPURE SYSTEM AS MANUFACTURED IN JERSEY SHORE, PA
27556 A II 11/26/2013 DOW CORNING CORP DOW CORNING(R) Q7-2587 30% SIMETHICONE EMULSION USP AS MANUFACTURED IN
HEMLOCK, MI
27557 A II 11/26/2013 DOW CORNING CORP DOW CORNING(R) MEDICAL ANTIFOAM A COMPOUND AS MANUFACTURED IN HEMLOCK,
MI
27558 A II 8/25/2013 WATERSTONE PHARMACEUTICALS HUBEI
CO LTD
L-Ala-pAF-OH HCl AS MANUFACTURED IN TIANMEN, CHINA
27559 A II 12/21/2013 ENALTEC LABS PRIVATE LTD ALCAFTADINE (ESUB) AS MANUFACTURED IN MAHARASTRA, INDIA
27560 A II 9/16/2013 SAMYANG BIOPHARMACEUTICALS CORP SEMISYNTHETIC PACLITAXEL AS MANUFACTURED IN DAEJEON, KOREA
27561 A IV 11/26/2013 DOW CORNING CORP DOW CORNING (R) 7-9245 30% SIMETHICONE EMULSION AND DOW CORNING (R)
MEDICAL ANTIFOAM C EMULSION AS MANUFACTURED IN HEMLOCK, MI
27562 P *** PENDING FILING REVIEW ***
27563 A II 12/30/2013 SCINOPHARM TAIWAN LTD FONDAPARINUX SODIUM (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA
27564 A II 12/30/2013 SCINOPHARM TAIWAN LTD GALANTAMINE (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA
27565 P *** PENDING FILING REVIEW ***
27566 P *** PENDING FILING REVIEW ***
27567 P *** PENDING FILING REVIEW ***
27568 A II 9/25/2013 CENTAUR PHARMACEUTICALS PRIVATE LTD ZALEPLON USP AS MANUFACTURED IN MAHARASHTRA, INDIA
27569 A II 9/27/2013 MSN LABORATORIES PVT LTD BORTEZOMIB [ROUTE CODE "BR"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27570 A II 9/30/2013 MSN PHARMACHEM PRIVATE LTD LURASIDONE HYDROCHLORIDE [ROUTE CODE "LN"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27571 A II 9/30/2013 MSN LABORATORIES PVT LTD PRASUGREL [ROUTE CODE - LP] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA Page 832
4Q2012 2Q2014EXCEL
27572 P *** PENDING FILING REVIEW ***
27573 A II 12/6/2013 HOUSTON CYCLOTRON PARTNERS LP 3'-DEOXY-3' -[18F] FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN HOUSTON,
TEXAS
27574 A II 7/25/2013 CAMBREX PROFARMACO MILANO SRL CYSTEAMINE BITARTRATE (RP) AS MANUFACTURED IN PAULLO, (MILAN) ITALY
27575 A III 9/17/2013 CYTECH COATINGS PVT LTD LAMINATION ADHESIVES AS MANUFACTURED IN GUJARAT, INDIA.
27576 N NOT AN ASSIGNED NUMBER
27577 A II 12/19/2013 POLYPEPTIDE LABORATORIES SWEDEN AB VASOPRESSIN AS MANUFACTURED IN LIMHAMN, SWEDEN
27578 N NOT AN ASSIGNED NUMBER
27579 A II 9/30/2013 IPCA LABORATORIES LTD CHLORTHALIDONE USP (CT6 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA
PRADESH, INDIA
27580 A II 9/20/2013 SEQUENT SCIENTIFIC LTD ETOMIDATE AS MANUFACTURED IN KARNATAKA, INDIA
27581 A III 9/17/2013 BORMIOLI ROCCO SPA BU PLASTICA DROPPER TSD LDPE AS MANUFACTURED IN CASTELGUELFO (PR) ITALY; RIVANAZZANO
(PV) ITALY; AND SAINT SULPICE, FRANCE
27582 A III 9/18/2013 NEW AGE INDUSTRIES INC ADVANTAPURE SILICONE APST TUBING NI202 AS MANUFACTURED IN SOUTHAMPTON,
PA
27583 A II 10/21/2013 VASUDHA PHARMA CHEM LTD PIMOZIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27584 A II 12/5/2013 ALP PHARM BEIJING CO LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU PROVINCE,
CHINA FOR ALP PHARM BEIJING CO., LTD
27585 A II 11/27/2013 CHUNGHWA CHEMICAL SYNTHESIS AND
BIOTECH CO LTD
CASPOFUNGIN ACETATE (ESUB) AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN
27586 A II 9/24/2013 MOEHS IBERICA SL PRILOCAINE HYDROCHLORIDE AS MANUFACTURED IN LESSINES BELGIUM FOR MOEHS
IBERICA S.L.
27587 A III 9/23/2013 BOREALIS AG BORMED LE6600-PH AS MANUFACTURED SCHWECHAT-MANNSWORTH, AUSTRIA FOR
BOREALIS AG
27588 A IV 9/25/2013 FONA INTERNATIONAL INC PRODUCT # 815.016 N-C BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN
GENEVA, IL
27589 A II 9/29/2013 ALP PHARM BEIJING CO LTD CLOPIDOGREL BISULFATE FORM II (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA FOR
ALP PHARM BEIJING CO., LTD
27590 N NOT AN ASSIGNED NUMBER
27591 A II 10/30/2013 SINOPEP JIANGSU INC DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27592 A II 11/28/2013 SUN PHARMACEUTICAL INDUSTRIES LTD CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27593 A II 3/20/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD FOSAMPRENAVIR CALCIUM (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO,
CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
27594 A III 9/2/2013 SCORPION CONTAINERS PRIVATE LTD HDPE BOTTLE SET (BOTTLE, CAP, MEASURING CUP) AS MANUFACTURED IN GUJARAT,
INDIA
27595 A III 9/25/2013 3M DRUG DELIVERY SYSTEMS DIVISION 3M COTRAN 9695 TAN SPUNLACE NONWOVEN TAPE AS MANUFACTURED IN
BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS DIVISION
27596 A II 11/5/2013 JIANGSU GRAND XIANLE PHARMACEUTICAL
CO LTD
MEGESTROL ACETATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
27597 A II 9/25/2013 VIWIT PHARMACEUTICAL CO LTD (2R, 3S)-2[(1R)-1-[3,5-BIS(TRIFLUOROMETHYL)PHENYL]ETHOXY]-3-(4-FLUOROPHENYL)-
MORPHOLINE, 4-METHYLBENZENESULFONATE AS MANUFACTURED SHANDONG
PROVINCE, CHINA
27598 A II 9/26/2013 KREATIVE ORGANICS PRIVATE LTD GLIPIZIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27599 A II 9/26/2013 EUTICALS INC SODIUM OXYBATE AS MANUFACTURED IN SPRINGFIELD, MISSOURI
27600 A II 2/26/2014 YUNG SHIN PHARMACEUTICAL INDUSTRIAL
CO LTD
ENTECAVIR MONOHYDRATE (ESUB) AS MANUFACTURED IN TAIWAN, R.O. CHINA
Page 833
4Q2012 2Q2014EXCEL
27601 P *** PENDING FILING REVIEW ***
27602 A II 10/1/2013 HETERO LABS LTD LAPATINIB DITOSYLATE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27603 A II 10/1/2013 NOF CORP A-SUCCINIMIDYLOXYSUCCINYL-w-METHOXY, POLYOXYETHYLENE MW:4,500 AS
MANUFACTURED KAWASAKI-SHI, KANAGAWA, JAPAN
27604 A III 9/23/2013 STERI-PLAS PTY LTD 150ML TABLET BOTTLE AS MANUFACTURED IN MOOREBANK NSW, AUSTRALIA
27605 A II 9/30/2013 ALCHEM INTERNATIONAL LTD DIGOXIN USP AS MANUFACTURED IN HARYANA, INDIA
27606 A III 9/27/2013 TEKNOR COLOR CO 71,094HCP ORANGE 50:1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE,
TX
27607 A II 8/2/2013 PHAEX POLYMERS PRIVATE LTD CHOLESTYRAMINE RESIN USP AS IN MANUFACTURED MAHARASHTRA, INDIA
27608 A II 9/30/2013 SIGMA ALDRICH IRELAND LTD SODIUM BENZOATE AS MANUFACTURED IN WICKLOW, ILRELAND FOR SIGMA ALDRICH
IRELAND LTD.
27609 A II 10/24/2013 BHARAT PHARMA DILUTED NITROGLYCERIN USP AS MANUFACTURED IN LALITPUR, INDIA
27610 A II 1/10/2014 GLENMARK GENERICS LTD APREPITANT (BO74 PROCESS) (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA
27611 A II 9/30/2013 HIKAL LTD DONEPEZIL HYDROCHLORIDE API AS MANUFACTURED IN KARNATAKA, INDIA
27612 A II 11/30/2013 MSN LABORATORIES PVT LTD ROFLUMILAST [ROUTE CODE - "RO"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27613 A III 10/4/2013 MINNESOTA RUBBER AND PLASTICS SILICONES FOR SEALING APPLICATIONS IN MEDICAL DEVICES AS MANUFACTURED IN
LITCHFIELD, MN
27614 A II 10/11/2013 MSN LABORATORIES PVT LTD POSACONAZOLE AMORPHOUS [ROUTE CODE PKA] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27615 A II 10/21/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD PRAVASTATIN SODIUM USP (PROCESS II) (ESUB) AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
27616 A II 11/19/2013 EMCURE PHARMACEUTICALS LTD EPL 001 (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27617 A II 10/25/2013 EMCURE PHARMACEUTICALS LTD GEMCITABINE HYDROCHLORIDE USP (PROCESS II) (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27618 A II 12/27/2013 EMCURE PHARMACEUTICALS LTD OLSALAZINE SODIUM (PROCESS II) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27619 A IV 9/26/2013 SEPPIC SA SEPITRAP 80 AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S.A.
27620 A II 10/1/2013 PHARMACEUTICAL WORKS POLPHARMA SA DABIGATRAN ETEXILATE METHANESULFONATE AS MANUFACTURED IN GDANSKI,
POLAND
27621 A III 9/17/2013 BORMIOLI ROCCO SPA BU PLASTICA BOTTLE LDPE 3-5 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO
(PV), ITALY; AND SAINT SULPICE, FRANCE
27622 A II 9/27/2013 IRVINE SCIENTIFIC SALES CO DSP06B POWDER AS MANUFACTURED IN SANTA ANA, CA
27623 A II 10/18/2013 INDUSTRIALE CHIMICA SRL DALFAMPRIDINE AS MANUFACTURED IN SARONNO (VARESE), ITALY
27624 A II 9/23/2013 MURLI KRISHNA PHARMA PVT LTD ORLISTAT PELLETS 50.0% W/W AS MANUFACTURED IN MAHARASHTRA, INDIA
27625 A II 10/8/2013 IRVINE SCIENTIFIC SALES CO PRIME-XV AFSC EXPANSION MEDIUM AS MANUFACTURED IN SANTA ANA, CA
27626 A II 9/23/2013 MURLI KRISHNA PHARMA PVT LTD TACROLIMUS PELLETS 5.0% W/W AS MANUFACTURED IN MAHARASHTRA, INDIA
27627 A II 10/8/2013 KREATIVE ORGANICS PRIVATE LTD SODIUM PICOSULFATE USP AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH,
INDIA
27628 A II 12/27/2013 3D IMAGING DRUG DESIGN AND
DEVELOPMENT LLC
[I-124]CLR1404 INJECTION (ESUB) AS MANUFACTURED IN LITTLE ROCK, ARKANSAS
27629 N NOT AN ASSIGNED NUMBER
27630 A III 10/8/2013 CLARIANT CORP MATERIAL FOR PLASTIC PACKAGING AS MANUFACTURED IN LEWISTON, ME; MALMO,
SWEDEN; SINGAPORE
27631 A II 7/19/2013 HUNAN YUXIN PHARMACEUTICAL CO LTD 16A-HYDROXY PREDNISOLONE AS MANUFACTURED IN HUNAN PROVINCE, P.R. CHINA
Page 834
4Q2012 2Q2014EXCEL
27632 A II 10/9/2013 ASYMCHEM LIFE SCIENCE TIANJIN CO LTD ATAZANAVIR SULFATE AS MANUFACTURED IN TIANJIN, CHINA
27633 A II 10/28/2013 HETERO DRUGS LTD ROSUVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27634 A II 11/12/2013 INDOCO REMEDIES LTD RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
27635 P *** PENDING FILING REVIEW ***
27636 A II 12/4/2013 APOTEX PHARMACHEM INDIA PVT LTD TOLVAPTAN AS MANUFACTURED IN BANGALORE, INDIA
27637 A II 11/1/2013 ALKEM LABORATORIES LTD DALFAMPRIDINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27638 A III 10/8/2013 TOPPAN PRINTING CO LTD A PET/EVA BACKING FILM FOR TRANSDERMAL DRUG DELIVERY PATCHES AS
MANUFACTURED IN FUKUOKA, JAPAN FOR TOPPAN PRINTING CO., LTD
27639 A II 10/31/2013 TORRENT PHARMACEUTICALS LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
27640 A III 10/8/2013 GERRESHEIMER REGENSBURG GMBH MDI COUNTER AS MANUFACTURED IN HORSOVSKY TYN, CZECH REPUBLIC FOR
GERRESHEIMER REGENSBURG GMBH
27641 N NOT AN ASSIGNED NUMBER
27642 N NOT AN ASSIGNED NUMBER
27643 N NOT AN ASSIGNED NUMBER
27644 N NOT AN ASSIGNED NUMBER
27645 A II 12/19/2013 LUPIN LTD LATANOPROST USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA
27646 A II 10/17/2013 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
SODIUM PICOSULFATE AS MANUFACTURED IN GUJARAT, INDIA
27647 A II 10/15/2013 PROCOS SPA DALFAMPRIDINE (INN: FAMPRIDINE) AS MANUFACTURED IN CAMERI NOVARA, ITALY
27648 A II 1/8/2014 TEVA PHARMACEUTICALS INDUSTRIES LTD DEFERASIROX (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD.
27649 A II 10/21/2013 DISHMAN PHARMACEUTICALS AND
CHEMICALS LTD
GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
27650 A II 3/3/2014 PIRAMAL ENTERPRISES LTD DONEPEZIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27651 A II 12/19/2013 CHENGDU SHENGNUO BIOPHARM CO LTD EPTIFIBATIDE (ESUB) AS MANUFACTURED IN SICHUAN, CHINA
27652 A III 10/7/2013 DONGWON SYSTEMS ALUALU AS MANUFACTURED IN CHUNGNAM, KOREA
27653 A IV 10/16/2013 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
716206 NAT & ART RASPBERRY FLAVOR AS MANUFACTURED IN CLARK, NJ
27654 A III 10/9/2013 BOREALIS AG BORMED HE7541-PH AS MANUFACTURED IN SCHWECHAT-MANNSWORTH, AUSTRIA FOR
BOREALIS AG
27655 A III 10/23/2013 HAEMOTRONIC SPA PVC-FREE PLASTIC CONTAINERS FOR INFUSION AS MANUFACTURED IN MIRANDOLA
(MO), ITALY AND CARBONARA DI PO (MN), ITALY
27656 A III 10/9/2013 BOREALIS AG BORMED HE2581-PH AS MANUFACTURED IN SCHWECHAT-MANNSWORTH, AUSTRIA FOR
BOREALIS AG
27657 A III 10/23/2013 ZEON CORP CYCLO OLEFIN POLYMER 3 AS MANUFACTURED IN OKAYAMA, JAPAN
27658 A III 11/13/2013 NYPRO INC QVAR MDI ACTUATOR / DOSE COUNTER ASSEMBLY AS MANUFACTURED IN COUNTY
DUBLIN, COUNTY WATERFORD, IRELAND FOR NYPRO INC.
27659 A II 12/20/2013 ABX ADVANCED BIOCHEMICAL COMPOUNDS
BIOMEDIZINISCHE
FORSCHUNGSREAGENZIEN GMBH
BETIATIDE AS MANUFACTURED IN RADEBERG, GERMANY
27660 A II 10/25/2013 NUTRI GRANULATIONS DIRECTLY COMPRESSIBLE GRANULATED CALCIUM CARBONATE WITH GUM ACACIA AS
MANUFACTURED IN LA MIRADA, CA
27661 A II 10/21/2013 PHARMACEUTICAL WORKS POLPHARMA SA RIVAROXABAN AS MANUFACTURED IN GDANSKI, POLAND
Page 835
4Q2012 2Q2014EXCEL
27662 A II 11/18/2013 SUN PHARMACEUTICAL INDUSTRIES LTD DALFAMPRIDINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27663 A II 2/14/2014 SUN PHARMACEUTICAL INDUSTRIES LTD LEVALBUTEROL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27664 A II 10/25/2013 HEC PHARM GROUP ATORVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN
HUBEI PROVINCE, P.R. CHINA FOR HEC PHARM GROUP
27665 P *** PENDING FILING REVIEW ***
27666 A II 10/28/2013 ROVI CONTRACT MANUFACTURING SL STERILE WATER FOR INJECTION, 1 ML PREFILLED SYRINGE AS MANUFACTURED IN
MADRID, SPAIN
27667 A II 10/10/2013 CAMBREX CHARLES CITY INC OPIUM TINCTURE 2% AS MANUFACTURED IN CHARLES CITY, IA
27668 A II 11/1/2013 HUBEI GEDIAN HUMANWELL
PHARMACEUTICAL CO LTD
PROGESTERONE (ESUB) AS MANUFACTURED IN HUBEI, P.R. CHINA
27669 A II 12/18/2013 CADILA HEALTHCARE LTD IMATINIB MESYLATE (AMORPHOUS) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27670 A II 11/19/2013 POLYCARBON INDUSTRIES INC DBA PCI
SYNTHESIS
PCI-104400 NON-STERILE BULK DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN
NEWBURYPORT, MA.
27671 A III 10/28/2013 VP INDUSTRIAL CORP SILICA GEL PACKED IN TYVEK BAGS AS MANUFACTURED IN CHENNAI , INDIA
27672 A II 12/25/2013 AURISCO PHARMACEUTICAL LTD EPLERENONE AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. CHINA FOR AURISCO
PHARMACEUTICAL LIMITED
27673 A II 11/12/2013 AMOLI ORGANICS PVT LTD LINEZOLID [FORM-II] (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27674 A II 10/29/2013 AVANTI POLAR LIPIDS INC (5S, 6R, E)-METHYL 5,6-DIHYDROXY-8-(2-((R,E)-3-HYDROXYOCT-1-ENYL)PHENYL)OCT-7-
ENOATE(9,12-BENZO-LXA4) AS MANUFACTURED IN ALABASTER, AL
27675 A II 10/8/2013 BIOCON LTD ROSUVASTATIN CALCIUM(PRODUCT CODE 8004368) AS MANUFACTUREED IN
BANGALORE AND ANDHRA PRADESH, INDIA
27676 A III 10/29/2013 POLYONE CORP CC10105451XX (197C PINK PE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
27677 A III 10/19/2013 M AND H PLASTICS HDPE, PETE, PTCG BOTTLES AS MANUFACTURED IN WINCHESTER, VA, AND BECCLES,
ENGLAND
27678 A II 12/13/2013 PAR PHARMACEUTICAL INC DAPSONE USP (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR
PHARMACEUTIAL, INC
27679 A II 10/30/2013 FARMAK AS ZILEUTON AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC
27680 A II 10/16/2013 YONSUNG FINE CHEMICALS CO LTD TREPROSTINIL SODIUM AS MANUFACTURED IN GYEONGGI-DO, REPUBLIC OF KOREA
27681 A II 10/31/2013 IRVINE SCIENTIFIC SALES CO PRIME-XV TUMORSPHERE SFM AS MANUFACTURED IN SANTA ANA, CA
27682 A II 10/31/2013 IRVINE SCIENTIFIC SALES CO PRIME-XV NPC EXPANSION XSFM AS MANUFACTURED IN SANTA ANA, CA
27683 A III 10/30/2013 POLYONE CORP CC10170184XX(WHITE ABS) AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND
NORWALK, OH
27684 A III 10/30/2013 POLYONE CORP CC10189184XX (BLUE) AS MANUFACTURED IN ELK GROVE VILLAGE IL, AND NORWALK,
OH
27685 A III 10/30/2013 POLYONE CORP CC10180743XX (OM WHITE) AS MANUFACTURED IN ELK GROVE VILLIAGE, IL AND
NORWALK, OH
27686 A II 11/1/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
MEROPENEM, STERILE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
27687 A II 10/31/2013 3M PURIFICATION INC LIFEASSURE PFC SERIES FILTERS AS MANUFACTURED IN MERIDEN, CT
27688 A IV 10/28/2013 NUSIL TECHNOLOGY LLC DDU-4331 LIQUID SILICONE ELASTOMER (S) AS MANUFACTURED IN CARPINTERIA, CA
27689 A IV 10/28/2013 NUSIL TECHNOLOGY LLC DDU-1135 RTV SILICONE ADHESIVE (S) AS MANUFACTURED IN CARPINTERIA, CA
27690 A IV 10/28/2013 NUSIL TECHNOLOGY LLC DDU-4342 RTV SILICONE ELASTOMER (S) AS MANUFACTURED IN CARPINTERIA, CA
27691 A IV 10/28/2013 NUSIL TECHNOLOGY LLC DDU-4352 SILICONE GEL AS MANUFACTURED IN CARPINTERIA, CA
Page 836
4Q2012 2Q2014EXCEL
27692 A II 10/20/2013 QINHUANGDAO ZIZHU PHARMACEUTICAL
CO LTD
LEVONORGESTREL (MICRONIZED) AS MANUFACTURED IN HEBEI PROVINCE, CHINA
27693 A III 10/22/2013 ANHUI HUAFENG PHARMACEUTICAL
RUBBER CO LTD
POLYPROPYLENE THERMOPLASTIC ELASTOMER COMBINATION CAP FOR PLASTIC
CONTAINERS FILLED WITH AQUEOUS PARENTERAL PREPARATIONS AS MANUFACTURED
IN ANHUI PROVINCE, P.R., CHINA
27694 A II 10/31/2013 LONZA AG ETH06 (TRABECTEDIN INTERMEDIATE) AS MANUFACTURED IN VISP, SWITZERLAND
27695 A III 10/30/2013 VPET USA PET BOTTLES, JARS AND CONTAINERS FOR PHARMACEUTICAL AND FOOD APPLICATION
BY STRETCH-BLOW-MOLDING PROCESS AS MANUFACTURED IN FONTANA, CA, PORT
HURON, MI AND TAIWAN
27696 A II 11/29/2013 ZY PHARMACEUTICALS CO LTD TIGECYCLINE AS MANUFACTURED IN HUBEI PROVINCE, CHINA
27697 A II 12/18/2013 CADILA HEALTHCARE LTD ATORVASTATIN CALCIUM USP (AVE ROUTE) (ESUB) AS MANUFACTURED IN GUJARAT,
INDIA
27698 A III 10/22/2013 ANHUI HUAFENG PHARMACEUTICAL
RUBBER CO LTD
ETFE COATED CHLORINATED BUTYL RUBBER STOPPER FOR INJECTABLE PRODUCTS
(AQUEOUS PARENTERAL PREPARATIONS, POWDERS AND LYOPHILIZED POWDERS) AS
MANUFACTURED IN ANHUI PROVINCE, P.R., CHINA
27699 A III 10/22/2013 ANHUI HUAFENG PHARMACEUTICAL
RUBBER CO LTD
ETFE COATED BROMINATED BUTYL RUBBER STOPPER FOR INJECTABLE PRODUCTS
(AQUEOUS PARENTERAL PREPARATIONS, POWDERS AND LYOPHILIZED POWDERS) AS
MANUFACTURED IN ANHUI PROVINCE, P.R.,CHINA
27700 A II 1/20/2014 JOHNSON MATTHEY PHARMACEUTICAL
MATERIALS
JOHNSON MATTHEY B1396 (ESUB) AS MANUFACTURED IN WEST DEPTFORD, NJ
27701 A II 11/6/2013 SAI LIFE SCIENCES LTD DAPSONE USP AS MANUFACTURED IN KARNATAKA, INDIA
27702 A II 11/28/2013 BIOCON LTD HUMAN INSULIN DRUG SUBSTANCE (rDNA ORIGIN) (ESUB) AS MANUFACTURED IN
BANGALORE, INDIA
27703 A II 10/21/2013 KREITCHMAN PET CENTER [11C]-MDL100907 AS MANUFACTURED IN NEW YORK, NY.
27704 A II 9/26/2013 JIAZHONG NOVEL MATERIAL CORP HYBRID SILICA MICROSPHERE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
27705 A II 1/23/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD ESZOPICLONE (ESUB) AS MANUFACTURED IN GUAYAMA, PUERTO RICO FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
27706 A II 9/26/2013 JIAZHONG NOVEL MATERIAL CORP BONDED SILICA MICROSPHERE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
27707 A II 9/26/2013 JIAZHONG NOVEL MATERIAL CORP SILICA MICROSPHERE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
27708 A II 11/11/2013 SEQUENT SCIENTIFIC LTD CITICOLINE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA
27709 A III 11/8/2013 ONLY FOR CHILDREN PHARMACEUTICALS CONTAINER CLOSURE SYSTEM NAMED THE SHAKER AS MANUFACTURED IN TREFFORT-
CUISIAT, FRANCE FOR ONLY FOR CHILDREN PHARMACEUTICALS
27710 A II 11/11/2013 DSM FINE CHEMICALS AUSTRIA NFG GMBH
AND CO KG
SILVER SULFADAZINE AS MANUFACTURED IN LINZE, AUSTRIA
27711 A IV 10/8/2013 HAYASHIBARA CO LTD PULLULAN AS MANUFACTURED IN OKAYAMA, JAPAN
27712 A III 11/8/2013 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN B25271 BLUE 5415C AND W09473 WHITE Q610-7-5 COLORANT
MASTERBATCHES AS MANUFACTURED IN ELK GROOVE VILLAGE, IL AND SPARTANBURG,
SC
27713 A II 9/21/2013 CALYX CHEMICALS AND PHARMACEUTICALS
LTD
AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA
27714 A II 1/13/2014 POLYPEPTIDE LABORATORIES SWEDEN AB EXENDIN-4 ACETATE (EXENATIDE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
FOR POLYPEPTIDE LABORATORIES (SWEDEN) AB
27715 A II 10/22/2013 HUBEI HAOSUN PHARMACEUTICAL CO LTD TEMOZOLOMIDE AS MANUFACTURED IN HUBEI, P.R. CHINA
27716 A IV 11/13/2013 FONA INTERNATIONAL INC 884.114 N-C ORANGE FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
27717 A II 11/11/2013 FARMABIOS SPA LOTEPREDNOL ETABONATE STERILE MICRONIZED AS MANUFACTURED IN GROPELLO
CAIROLI (PV), ITALY
Page 837
4Q2012 2Q2014EXCEL
27718 A II 11/26/2013 LEK PHARMACEUTICALS DD FERUMOXYTOL AS MANUFACTURED IN MENGES, SLOVENIA
27719 A II 12/17/2013 LEK PHARMACEUTICALS DD ENTECAVIR MONOHYDRATE AS MANUFACTURED IN ONTARIO, CANADA; WESTFALEN
GERMANY AND BALERNA, SWITZERLAND FOR LEK PHARMACEUTICALS D.D.
27720 A II 11/22/2013 MSN LABORATORIES PVT LTD POSACONAZOLE (FORM-I) [ROUTE CODE - "PJ1"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27721 A II 11/30/2013 MSN LABORATORIES PVT LTD TOFACITINIB CITRATE [ROUTE CODE - "TT"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27722 A II 12/6/2013 PAR PHARMACEUTICAL INC COLCHICINE USP (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR
PHARMACEUTICAL, INC
27723 A II 12/12/2013 PEPTISYNTHA SA GLATIRAMER ACETATE (ESUB) AS MANUFACTURED IN BRUSSELS, BELGIUM
27724 A II 12/19/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD IRINOTECAN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ZHJIANG PROVINCE,
CHINA
27725 A II 12/31/2013 HISUN PHARMACEUTICAL HANGZHOU CO
LTD
SIROLIMUS (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27726 A II 1/31/2014 CADILA PHARMACEUTICALS LTD PHTHALOYL AMLODIPINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27727 A II 12/27/2013 MYLAN LABORATORIES LTD ELVITEGRAVIR (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27728 A II 12/24/2013 MYLAN LABORATORIES LTD RALTEGRAVIR POTASSIUM (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27729 A II 12/20/2013 MYLAN LABORATORIES LTD OCTREOTIDE ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27730 A II 12/17/2013 MYLAN LABORATORIES LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27731 A II 12/6/2013 VASUDHA PHARMA CHEM LTD LOPERAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27732 A II 2/6/2014 ASH STEVENS INC 8-CHLOROADENOSINE
AS MANUFACTURED IN DETROIT, MI
27733 A II 11/25/2013 JOYANG LABORATORIES BACITRACIN ZINC (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27734 A II 11/13/2013 SHOUGUANG FUKANG PHARMACEUTICAL
CO LTD
OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
27735 A III 9/20/2013 DANYANG XIANGHE PHARMACEUTICAL
PACKAGING CO LTD
INJECTION VIALS MADE OF NEUTRAL BOROSILICATE GLASS TUBING AS MANUFACTURED
IN JIANGSU PROVINCE, CHINA
27736 A III 11/11/2013 RAJAT VINYLS PRIVATE LTD RIGID PVC FILM FOR PHARMACEUTICAL AND FOOD PACKAGING APPLICATION AS
MANUFACTURED IN GUJARAT, INDIA
27737 A II 11/15/2013 ICEUTICA INC SOLUMATRIX ABIRATERONE ACETATE DRUG PRODUCT INTERMEDIATE AS
MANUFACTURED IN QUAKERTOWN, PA FOR ICEUTICA INC.
27738 A IV 11/12/2013 LIPOID GMBH LIPOID PURIFIED OLEIC ACID (PH.EUR.) AS MANUFACTURED IN LUDWIGSHAFEN,
GERMANY
27739 A V 11/18/2013 ZHUHAI UNITED LABORATORIES CO LTD STERILIZATION PROCESS VALIDATION INFORMATION FOR CARBOPENEM STERILE
PRODUCTS
27740 A IV 8/2/2013 PJ HEALTHCARE PNEU 112 GRANULES AS MANUFACTURED IN GUJARAT, INDIA
27741 A II 10/5/2013 JIANGSU HUANXIN HIGH-TECH MATERIALS
CO LTD
CHLOROXYLENOL AS MANUFACTURED IN JIANGSU, P. R. CHINA
27742 A III 11/11/2013 PACKAGING INDIA PVT LTD PLAIN OR PRINTED POLYETHLENE TETRAPTHALATE/ ALUMINIUM FOIL/ POLYETHYLENE
LAMINATES AS MANUFACTURED IN PONDICHERRY, INDIA
27743 P *** PENDING FILING REVIEW ***
27744 A II 12/30/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD CELECOXIB USP (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27745 A II 11/12/2013 SCI PHARMTECH INC (S)-3-(METHYLAMINO)-1-(2-THIENYL) PROPAN-1-OL [(S)-MMAA] AS MANUFACTURED IN
TAOYUAN, TAIWAN
Page 838
4Q2012 2Q2014EXCEL
27746 A II 12/2/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD PIOGLITAZONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ZHEJIANG
PROVINCE, CHINA
27747 A III 11/15/2013 KUNSHAN WISEPAC DESICCANT CO LTD WISEMINI PACKED DESICCANT FOR PHARMACEUTICAL INDUSTRY WITH MOLECULE
SIEVE AS ABSORBENT, TYVEK 1059B AS PACKAGING MATERIAL AS MANUFACTURED IN
JIANGSU, CHINA
27748 A IV 10/25/2013 PJ HEALTHCARE INNOKOAT AS MANFUACTURED IN GUJARAT AND DAMAN, INDIA
27749 P *** PENDING FILING REVIEW ***
27750 A II 11/18/2013 ASYMCHEM LABORATORIES TIANJIN CO LTD ANASTROZOLE AS MANUFACTURED IN TIANJIN, CHINA
27751 A III 3/15/2013 CHROMA CORPORATION PC90261A CLARIFYING CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS
27752 A II 3/28/2014 AVANTOR PERFORMANCE MATERIALS INC SODIUM ACETATE TRIHYDRATE (ESUB) AS MANUFACTURED IN PHILLIPSBURG, NJ
27753 A II 4/25/2014 AVANTOR PERFORMANCE MATERIALS INC POTASSIUM PHOSPHATE MONOBASIC (ESUB) AS MANUFACTURED IN PHILLIPSBURG, NJ
27754 A II 4/25/2014 AVANTOR PERFORMANCE MATERIALS INC SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (ESUB) AS MANUFACTURED IN
PHILLIPSBURG, NJ
27755 A II 3/28/2014 AVANTOR PERFORMANCE MATERIALS INC POTASSIUM PHOSPHATE DIBASIC (ESUB) AS MANUFACTURED IN PHILLIPSBURG, NJ
27756 A II 11/20/2013 SHASUN PHARMACEUTICALS LTD PANTOPRAZOLE SODIUM, USP AS MANUFACTURED IN CUDDALORE, INDIA
27757 A IV 11/20/2013 FONA INTERNATIONAL INC 865.0037U LIME EXTRACT, NAT AS MANUFACTURED IN GENEVA, IL
27758 A IV 11/20/2013 FONA INTERNATIONAL INC 825.0597U N-C CHERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
27759 A II 11/21/2013 AMBIOPHARM INC OCTREOTIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH
AUGUSTA, SC; SHANGHAI, CHINA
27760 A III 11/7/2013 JIANGSU ZHONGJIN MATAI MEDICINAL
PACKAGING CO LTD
PA/AL/PVC COLD FORMING COMPOSITE SHEET FOR PACKAGING OF SOLID DOSAGE
FORMS AS MANUFACTURED IN JIANGSU, CHINA
27761 A II 12/10/2013 NISSAN CHEMICAL INDUSTRIES LTD PITAVASTATIN CALCIUM ( ASYMMETRIC SYNTHESIS METHOD) (ESUB) AS MFG IN
YAMAGUCHI, JAPAN
27762 A II 12/13/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD OXALIPLATIN (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27763 A II 12/16/2013 HUBEI GEDIAN HUMANWELL
PHARMACEUTICAL CO LTD
DUTASTERIDE ACID (ESUB) AS MANUFACTURED IN HUBEI, P.R. CHINA
27764 A II 11/20/2013 WANBURY LTD QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27765 A II 11/21/2013 INALCO SAS DI GIOVANNI CIPOLLETTI AND C LACTITOL MONOHYDRATE AS MANFACTURED IN PISTOIA, ITALY FOR INALCO S.A.S. DI
GIOVANNI CIPOLLETTI & C.
27766 P *** PENDING FILING REVIEW ***
27767 A II 12/26/2013 CADILA HEALTHCARE LTD ENTECAVIR (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27768 A III 12/18/2013 KAKEN PHARMACEUTICAL CO LTD PLASTIC CONTAINER FOR TOPICAL SOLUTION AS MANUFACTURED IN SHIZUOKA, JAPAN
27769 A II 12/26/2013 ZHEJIANG HISUN PHARMACEUTICAL CO LTD ROSUVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27770 A V 12/11/2013 EVONIK INDUSTRIES AG EUDRAGIT? E
27771 A II 1/10/2014 EMCURE PHARMACEUTICALS LTD DOCETAXEL TRIHYDRATE USP (PROCESS II) (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27772 A II 11/26/2013 IRVINE SCIENTIFIC SALES CO PRIME-XV MSC EXPANSION SFM AS MANUFACTURED IN SANTA ANA, CA
27773 A II 12/13/2013 NOVOZYMES AS SODIUM HYALURONATE FROM BACILLUS SUBTILIS (PARENTERAL GRADE): HYASIS(R)
850P (ESUB) AS MANUFACTURED IN TIANJIN, CHINA FOR NOVOZYMES AS
27774 A II 12/11/2013 HETERO LABS LTD DUTASTERIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27775 A V 11/26/2013 WEST PHARMACEUTICAL SERVICES INC STEAM STERILIZATION PROCESS
Page 839
4Q2012 2Q2014EXCEL
27776 A II 11/27/2013 ZHEJIANG JINHUA CONBA BIO-PHARM. CO.,
LTD.
AMIKACIN SULFATE USP AS MANUFACTURED IN ZHEJIANG, CHINA
27777 A II 9/6/2013 SHANGHAI DESANO CHEMICAL
PHARMACEUTICAL CO LTD
ROSUVASTATIN CALCIUM AS MANUFACTURED IN SHANGHAI, CHINA
27778 A II 12/26/2013 S AND B PHARMA INC DBA NORAC PHARMA PEN-10101 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA
27779 A II 3/28/2014 ALP PHARM BEIJING CO LTD ROFLUMILAST (ESUB) AS MANUFACTURED IN SHANDONG, CHINA FOR ALP PHARM
BEIJING CO., LTD
27780 A II 12/27/2013 ALEMBIC PHARMACEUTICALS LTD API DIV VALSARTAN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27781 A II 12/31/2013 ALEMBIC PHARMACEUTICALS LTD API DIV DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27782 A III 11/26/2013 PLASTIQUES VENTHENAT EXTRUSION ACRYTER FILM AS MANUFACTURED IN BARBEZIEUX, FRANCE
27783 A II 11/25/2013 SYMBIOTEC PHARMALAB LTD METHYLPREDNISOLONE, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
27784 A II 12/18/2013 SANDOZ PRIVATE LTD APREPITANT AS MANUFACTURED IN MAHARASHTRA, INDIA
27785 A II 1/8/2014 SANDOZ PRIVATE LTD MEROPENEM TRIHYDRATE, STERILE AS MANUFACTURED MAHARASHTRA, INDIA
27786 P *** PENDING FILING REVIEW ***
27787 A II 12/10/2013 MSN LABORATORIES PVT LTD PALIPERIDONE PALMITATE [ROUTE CODE - "PM"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27788 A II 6/13/2014 IND SWIFT LABORATORIES LTD DUTASTERIDE (ESUB) AS MANUFACTURED IN PUNJAB, INDIA
27789 A III 11/25/2013 TECHMER PM PM17418 BOTTLE BLOW BLEND COMPOUND AS MANUFACTURED IN RANCHO
DOMINGUEZ, CA
27790 A IV 12/3/2013 DAVID MICHAEL AND CO INC MICHAELOK NATURAL AND ARTIFICIAL ORANGE FLAVOR #4356 AS MANUFACTURED IN
PHILADELPHIA, PA
27791 P *** PENDING FILING REVIEW ***
27792 A II 12/26/2013 CADILA HEALTHCARE LTD PREGABALIN (PGC ROUTE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27793 A II 11/20/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
SORAFENIB TOSYLATE (VERSION NO.: 1) AS MANUFACTURED IN ZHEJIANG, CHINA
27794 A II 11/29/2013 SHANGHAI ACANA PHARMTECH CO., LTD. FONDAPARINUX INTERMEDIATE N3 AS MANUFACTURED IN SHANGHAI, P. R. CHINA
27795 A II 12/21/2013 AUROBINDO PHARMA LTD ISOSULFAN BLUE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27796 A IV 1/28/2014 EVONIK INDUSTRIES AG EUDRAGIT L/S AS MANUFACTURED IN DARMSTADT, GERMANY
27797 A II 12/30/2013 EMCURE PHARMACEUTICALS LTD CLOFARABINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27798 A III 11/18/2013 SAMET PLAST MASTER BATCHES AS MANUFACTURED IN GUJARAT, INDIA
27799 A III 12/3/2013 BOREALIS AG BORMED HG820MO AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG
27800 A II 12/23/2013 MICRO LABS LTD BROMFENAC SODIUM SESQUIHYDRATE (ESUB) AS MANUFACTURED IN KARNATAKA, India
27801 A II 12/8/2013 ZHEJIANG GUOBANG PHARMACEUTICAL CO
LTD
AZAERYTHROMYCIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA
27802 A II 12/9/2013 R.N. LABORATORIES PVT LTD. CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT, INDIA
27803 A III 2/23/2014 INDIAN OIL CORP LTD PROPEL HDPE 012DB54 (ESUB) AS MANUFACTURED IN HARYANA, INDIA.
27804 A II 5/23/2014 GLENMARK GENERICS LTD TELMISARTAN USP (D010 PROCESS) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27805 A II 12/28/2013 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
PHYTONADIONE (ROUTE B) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR
BIOPHORE INDIA PHARMACEUTICALS PVT. LTD.
27806 A II 1/8/2014 RELIABLE BIOPHARMACEUTICAL CORP CHLORAMPHENICOL HEMISUCCINATE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO
Page 840
4Q2012 2Q2014EXCEL
27807 A II 12/31/2013 MSN LABORATORIES PVT LTD RIVAROXABAN [ROUTE CODE "RR"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27808 A II 12/28/2013 MSN LABORATORIES PVT LTD TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27809 A II 12/6/2013 POLYMED THERAPEUTICS INC PEMETREXED DISODIUM 2.5 HYDRATE DRUG SUBSTANCE AS MANUFACTURED IN
CHONGQING, P.R. CHINA FOR POLYMED THERAPEUTICS, INC.
27810 A II 12/16/2013 GLOCHEM INDUSTRIES LTD AMLODIPINE BESYLATE (PROCESS 1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27811 A II 12/23/2013 TRIFARMA SPA FLUPHENAZINE DECANOATE AS MANUFACTURED IN ROZZANO (MI), ITALY
27812 A II 12/27/2013 ALCHYMARS ICM SM PRIVATE LTD SODIUM NITROPRUSSIDE USP AS MANUFACTURED IN TAMILNADU, INDIA
27813 A II 3/14/2014 JUBILANT LIFE SCIENCES LTD ROSUVASTATIN CALCIUM AMORPHOUS (ESUB) AS MANUFACTURED IN KARNATAKA,
INDIA
27814 A III 12/28/2013 ALPHAMED BOTTLES INC HDPE BOTTLES (ESUB) AS MANUFACTURED IN HAUPPAUGE, NEW YORK
27815 A III 12/11/2013 TOSOH CORP PETROTHENE 170K PACKAGING MATERIAL AS MANUFACTURED IN MIE, JAPAN
27816 A II 2/25/2014 JOHNSON MATTHEY PHARMA SERVICES 4245.C (MILLED) (ESUB) AS MANUFACTURED IN DEVENS, MA
27817 A III 12/10/2013 POLYONE CORP EM10031235XX (PELL-80AE TRANS RO BACONC) AS MANUFACTURED IN AVON LAKE, OH
27818 A II 12/11/2013 SYN-TECH CHEM AND PHARM CO LTD ZOLMITRIPTAN AS MANUFACTURED IN TAINAN CITY, TAIWAN
27819 A II 12/30/2013 INTAS PHARMACEUTICALS LTD DALFAMPRIDINE(ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27820 A II 12/30/2013 INTAS PHARMACEUTICALS LTD TRAZODONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27821 A II 12/30/2013 INTAS PHARMACEUTICALS LTD AZACITIDINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27822 A II 1/21/2014 ORIL INDUSTRIE PERINDOPRIL ARGININE (ESUB) AS MANUFACTURED IN BOLBEC, FRANCE
27823 P *** PENDING FILING REVIEW ***
27824 A II 12/11/2013 GW PHARMA LTD EPIDIOLEX AS MANUFACTURED IN SITTINGBOURNE KENT, UNITED KINGDOM
27825 A II 12/16/2013 SANOFI AVENTIS SPA ARTESUNATE AS MANUFACTURED IN GARESSIO, ITALY
27826 A II 2/4/2014 GLAND PHARMA LTD DEXRAZOXANE (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27827 A II 12/1/2013 SHANDONG XINHUA PHARMACEUTICAL CO
LTD
PHENOBARBITAL AS MANUFACTURED IN SHANDONG, P.R. CHINA
27828 A IV 12/16/2013 FONA INTERNATIONAL INC 852.272 N-C TUTTI FRUTTI FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
27829 A II 12/24/2013 MSN LABORATORIES PVT LTD ABIRATERONE ACETATE [ROUTE CODE "AY"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27830 A II 12/30/2013 MSN LABORATORIES PVT LTD FINGOLIMOD HYDROCHLORIDE [ROUTE CODE "FH"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27831 A II 3/3/2014 MSN LABORATORIES PVT LTD CABAZITAXEL [ROUTE CODE "CZ"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27832 A II 1/24/2014 SUN PHARMACEUTICAL INDUSTRIES LTD LEUPROLIDE ACETATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27833 A II 1/13/2014 JIANGSU HENGRUI MEDICINE CO LTD TOLVAPTAN (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27834 A II 2/6/2014 LUPIN LTD DEXLANSOPRAZOLE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27835 A II 12/31/2013 LUPIN LTD LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27836 A II 12/12/2013 QIDONG DONGYUE PHARMACEUTICAL CO
LTD
DEXTROMETHORPHAN HYDROBROMIDE AS MANUFACTURED IN JIANGSU, CHINA
27837 A II 3/6/2014 AMPHASTAR NANJING PHARMACEUTICALS
INC
BECLOMETHASONE DIPROPIONATE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA
27838 P *** PENDING FILING REVIEW ***
27839 A II 1/6/2014 INTAS PHARMACEUTICALS LTD PREGABALIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
Page 841
4Q2012 2Q2014EXCEL
27840 A III 12/19/2013 BOREALIS AG BORMED RJ88OMO AS MANUFACTURED IN BERINGEN, BELGIUM FOR BOREALIS AG
27841 A II 12/23/2013 LIVZON GROUP FUZHOU FUXING
PHARMACEUTICAL CO LTD
TOBRAMYCIN SULFATE AS MANUFACTURED IN FUJIAN PROVINCE, P.R. CHINA
27842 A II 1/7/2014 AUROBINDO PHARMA LTD VORICONAZOLE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27843 A II 1/9/2014 AUROBINDO PHARMA LTD DALFAMPRIDINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27844 A II 12/20/2013 MACCO ORGANIQUES INC SODIUM ACETATE ANHYDROUS AS MANUFACTURED IN QUEBEC, CANADA
27845 A III 12/20/2013 ZHEJIANG CENWAY NEW SYNTHETIC
MATERIALS CO LTD
BROMOBUTYL RUBBER AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
27846 A III 12/20/2013 ZHEJIANG CENWAY NEW SYNTHETIC
MATERIALS CO LTD
BUTYL RUBBER AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
27847 A III 11/12/2013 SCORPION CONTAINERS PRIVATE LTD PET BOTTLE SET (BOTTLE, CAP, MEASURING CUP) AS MANUFACTURED IN HIMACHAL
PRADESH, INDIA
27848 A II 1/7/2014 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
ENTECAVIR MONOHYDRATE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27849 A III 12/20/2013 ZHEJIANG CENWAY NEW SYNTHETIC
MATERIALS CO LTD
CHLOROBUTYL RUBBER AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
27850 A III 8/12/2013 BRIGHTWOOD PHARMMED CONSUMABLE
(BEIJING) LIMITED
NON-PVC IV SOFT BAG AS MANUFACTURED IN BEIJING, P.R. CHINA
27851 A III 9/2/2013 BEIJING AUSTAR HANSEN PACKAGING
TECHNOLOGY LTD
SHP-O CAP AND SHP-O PORT AS MANUFACTURED IN BEIJING, P.R. CHINA
27852 A III 12/18/2013 TRIMURTHI POLYMERS PET BOTTLES AS MANUFACTURED IN UNION TERRITORY OF DADRA & NAGAR HAVELI,
INDIA
27853 A II 12/24/2013 HUBEI BIOCAUSE HEILEN PHARMACEUTICAL
CO LTD
ABIRATERONE ACETATE AS MANUFACTURED IN WUHAN, P.R. CHINA FOR HUBEI
BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD.
27854 A IV 12/18/2013 UNGERER AND CO NAT. MARASCHINO CHERRY TYPE CONCENTRATE FI FW-9004 AS MANUFACTURED IN
BETHLEHEM, PA
27855 A III 12/23/2013 WINPAK HEAT SEAL PACKAGING INC FLEXIBLE PACKAGING MATERIALS FOR LIDDING AS MANUFACTIUED QUEBEC, CANADA
27856 A III 12/20/2013 STAR PLASTIC INDUSTRIES PLASTIC CONTAINERS, JARS, BOTTLES, CAPS AND CLOSURES AS MANUFACTURED IN
GUJARAT, INDIA
27857 A III 12/20/2013 ZHEJIANG HUAHAI PHARMACEUTICAL
PACKAGING PRODUCTS CO LTD
HDPE BOTTLES, 40 CC & 75 CC AS MANUFACTURED IN ZHEJIANG, CHINA
27858 A II 12/23/2013 IRVINE SCIENTIFIC SALES CO DME HIGH GLUCOSE-LIQUID # 9031 AS MANUFACTURED IN SANTA ANA, CA
27859 A II 1/28/2014 EMCURE PHARMACEUTICALS LTD FLECAINIDE ACETATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27860 A II 1/29/2014 MSN LABORATORIES PVT LTD TERIFLUNOMIDE [ROUTE CODE "TO"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27861 P *** PENDING FILING REVIEW ***
27862 A II 1/24/2014 MSN LABORATORIES PVT LTD CLOFARABINE [ROUTE CODE "CF"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27863 A II 1/31/2014 MSN LABORATORIES PVT LTD TRAVOPROST USP [ROUTE CODE - "TS"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27864 A IV 1/2/2014 FONA INTERNATIONAL INC 807.0274U N-C WILD BERRY TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL
27865 A II 1/27/2014 MSN LABORATORIES PVT LTD CARBOPROST TROMETHAMINE USP [ROUTE CODE "CE"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
27866 A II 3/5/2014 GLENMARK GENERICS LTD DIMETHYL FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27867 A II 1/27/2014 SYMBIOTEC PHARMALAB LTD LEVONORGESTREL EP/USP, MICRONIZED AS MANUFACTURED IN MADHYA PRADESH,
INDIA Page 842
4Q2012 2Q2014EXCEL
27868 A II 12/19/2013 FIRST RARE MATERIALS CO LTD BISMUTH CITRATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA
27869 A II 12/19/2013 FIRST RARE MATERIALS CO LTD BISMUTH SUBCARBONATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA
27870 A II 12/19/2013 FIRST RARE MATERIALS CO LTD BISMUTH SUBNITRATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA
27871 A II 12/19/2013 FIRST RARE MATERIALS CO LTD BISMUTH SUBSALICYLATE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA
27872 A II 12/4/2013 WATERSTONE PHARMACEUTICALS HUBEI
CO LTD
CELECOXIB AS MANUFACTURED IN HUBEI PROVINCE, CHINA
27873 A II 1/28/2014 AUROBINDO PHARMA LTD FONDAPARINUX SODIUM (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27874 A II 12/23/2013 IRVINE SCIENTIFIC SALES CO DME HIGH GLUCOSE-LIQUID #9024 AS MANUFACTURED IN SANTA ANA, CA
27875 A V 1/28/2014 LYOPHILIZATION SERVICES OF NEW
ENGLAND
INDOMETHACIN FOR INJECTION
27876 A II 12/31/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
ATAZANAVIR SULFATE AS MANUFACTURED IN ZHEJIANG, CHINA
27877 A IV 3/13/2014 EVONIK INDUSTRIES AG EUDRAGIT E AS MANUFACTURED IN DARMSTADT, GERMANY
27878 A IV 12/16/2013 HENKEL CORP DURO-TAK 87-6909 AS MANUFACTURED IN SALISBURY, NC
27879 A II 2/7/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD ROSUVASTATIN CALCIUM PROCESS G (ESUB) AS MANUFACTURED IN BE'ER SHEVA,
ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
27880 A II 1/3/2014 SHANDONG RONGYUAN PHARMACEUTICAL
CO LTD
TRIMETHOPRIM AS MANUFACTURED IN SHANDONG, P.R. CHINA
27881 A III 1/2/2014 NYPRO INC TWINCAPS (R) DRY POWDER INHALER COMPONENTS AS MANUFACTURED IN CO DUBLIN,
IRELAND FOR NYPRO, INC.
27882 A II 1/24/2014 HENAN TOPFOND PHARMACEUTICAL CO
LTD
SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN HENAN PROVINCE, P.R. CHINA
FOR HENAN TOPFOND PHARMACEUTICAL CO., LTD
27883 A II 1/6/2014 INTERQUIM SA DE CV DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN ESTADO DE MEXICO,
MEXICO
27884 A II 12/10/2013 MAHIMA LIFE SCIENCES PRIVATE LTD MECOBALAMIN JP AS MANUFACTURED IN HARYANA, INDIA
27885 A II 12/2/2013 MAHIMA LIFE SCIENCES PRIVATE LTD AZITHROMYCIN USP (DIHYDRATE) AS MANUFACTURED IN HARYANA, INDIA
27886 A II 12/5/2013 MAHIMA LIFE SCIENCES PRIVATE LTD CHLORAMPHENICOL PALMITATE USP AS MANUFACTURED IN HARYANA, INDIA
27887 A II 12/20/2013 MAHIMA LIFE SCIENCES PRIVATE LTD OFLOXACIN USP AS MANUFACTURED IN HARYANA, INDIA
27888 A II 12/10/2013 MAHIMA LIFE SCIENCES PRIVATE LTD DEXAMETHASONE USP AS MANUFACTURED IN HARYANA, INDIA
27889 A II 12/15/2013 MAHIMA LIFE SCIENCES PRIVATE LTD ERYTHROMYCIN ESTOLATE USP AS MANUFACTURED IN HARYANA, INDIA
27890 A II 12/5/2013 MAHIMA LIFE SCIENCES PRIVATE LTD BETAMETHASONE USP AS MANUFACTURED IN HARYANA, INDIA
27891 A II 12/15/2013 MAHIMA LIFE SCIENCES PRIVATE LTD ERYTHROMYCIN STEARATE USP AS MANUFACTURED IN HARYANA, INDIA
27892 A II 3/25/2014 GLENMARK GENERICS LTD DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27893 A III 1/22/2014 INDIAN OIL CORP LTD PROPEL PP1110MAS (ESUB) AS MANUFACTURED IN HARYANA, INDIA
27894 A II 4/21/2014 POLYCARBON INDUSTRIES INC DBA PCI
SYNTHESIS
PCI-103101 NON-STERILE BULK DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN
NEWBURYPORT, MA
27895 A II 2/18/2014 DR REDDYS LABORATORIES LTD CABAZITAXEL (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27896 A II 2/6/2014 DR REDDYS LABORATORIES LTD EZETIMIBE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.
27897 A III 1/3/2014 SHREE GAURAV RUBBER PRODUCTS SILICON RUBBER TUBING PEROXIDE/PLATINUM TREATED AS MANUFACTURED IN
MAHARASHTRA, INDIA
27898 A II 4/30/2014 AMSA SPA LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN COMO, ITALY
27899 A III 1/3/2014 SHREE GAURAV RUBBER PRODUCTS SILICONE RUBBER BRAIDED TUBING AS MANUFACTURED IN MAHARASHTRA, INDIA
27900 A II 1/9/2014 POLYMED THERAPEUTICS INC PACLITAXEL USP (SEMI-SYNTHETIC) AS MANUFACTURED IN CHONGQING, P.R. CHINA
FOR POLYMED THERAPEUTICS, INC.
Page 843
4Q2012 2Q2014EXCEL
27901 A II 2/5/2014 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
CLOFARABINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT. LTD
27902 A II 1/10/2014 ASYMCHEM LIFE SCIENCE TIANJIN CO LTD ATORVASTATIN CALCIUM AS MANUFACTURED IN TIANJIN, CHINA
27903 A II 2/5/2014 SINOPHARM WEIQIDA PHARMACEUTICAL
CO LTD
CLAVULANATE POTASSIUM, USP (ESUB) AS MANUFACTURED IN SHANXI, CHINA
27904 A II 2/19/2014 AJINOMOTO OMNICHEM SA MICONAZOLE NITRATE AS MANUFACTURED IN WETTEREN, BELGIUM
27905 A II 2/3/2014 RELIANCE LIFE SCIENCES PVT LTD LENALIDOMIDE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA
27906 A IV 1/7/2014 SYMRISE AG 650722 NATURAL & ARTIFICIAL FLAVOR CRANBERRY TYPE SPRAY DRIED AS
MANUFACTURED IN HOLZMINDEN, GERMANY
27907 A II 3/24/2014 GLENMARK GENERICS LTD LINAGLIPTIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27908 A II 3/25/2014 NAVINTA LLC SEVELAMER HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR
NAVINTA LLC
27909 A II 2/13/2014 ALKEM LABORATORIES LTD ARIPIPRAZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27910 A II 4/17/2014 TARO PHARMACEUTICAL INDUSTRIES LTD ILOPERIDONE, MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA, ISRAEL
27911 P *** PENDING FILING REVIEW ***
27912 P *** PENDING FILING REVIEW ***
27913 A III 1/6/2014 AMERICHEM INC 46344-CD4-801 AMBER AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM
27914 A IV 1/10/2014 SEPPIC SA SEPIFILM AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S.A.
27915 A II 3/11/2014 HEC PHARM CO LTD METOPROLOL SUCCINATE NON-STERILE BULK DRUG SUBSTANCE (ESUB) AS
MANUFACTURED IN HUBEI PROVINCE, P. R. CHINA FOR HEC PHARM CO., LTD
27916 A III 1/15/2014 BOREALIS AG BORMED SC876CF AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG
27917 A II 4/10/2014 HEC PHARM CO LTD CLOPIDOGREL BISULFATE NON-STERILE BULK DRUG SUBSTANCE (ESUB) AS
MANUFACTURED IN HUBEI PROVINCE, P.R CHINA FOR HEC PHARM CO., LTD
27918 A II 4/8/2014 HEC PHARM CO LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE
(ESUB) AS MANUFACTURED IN HUBEI PROVINCE, P. R. CHINA FOR HEC PHARM CO., LTD
27919 P *** PENDING FILING REVIEW ***
27920 A II 2/19/2014 SYMBIOTEC PHARMALAB LTD ESTERIFIED ESTROGENS USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
27921 A II 1/15/2014 SUPRIYA LIFESCIENCE LTD KETAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
27922 A II 1/17/2014 SANDOZ PRIVATE LTD MEROPENEM WITH SODIUM CARBONATE, STERILE BLEND AS MANUFACTURED IN
MAHARASHTRA, INDIA
27923 A II 3/7/2014 APOTEX PHARMACHEM INDIA PVT LTD ETRAVIRINE AS MANUFACTURED IN BANGALORE, INDIA
27924 A III 2/17/2014 LLC SCHOTT PHARMACEUTICAL PACKAGING PRIMARY PACKAGING MATERIAL (AMPOULES VIALS) AS MANUFACTURED IN ZAVOLZHYE,
RUSSIA
27925 A II 1/17/2014 METROCHEM API PRIVATE LTD ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN HYDERABAD, INDIA
27926 A II 2/7/2014 AUROBINDO PHARMA LTD SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27927 A II 3/28/2014 SHILPA MEDICARE LTD IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN KARNATAKA INDIA
27928 A II 1/17/2014 METROCHEM API PRIVATE LTD OMEPRAZOLE AS MANUFACTURED IN HYDERABAD, INDIA
27929 A III 1/15/2014 MITSUI CHEMICALS TOHCELLO INC RELEASE FILM AS MANUFACTURED IN TOKUSHIMA, JAPAN FOR MITSUI CHEMICALS
TOHCELLO, INC
27930 A III 1/17/2014 DANAPAK FLEXIBLES AS DANAEXTRA 15-35 COMPOUND PACKAGING MATERIAL AS MANUFACTURED IN SLAGELSE
AND HORSENS, DENMARK
27931 A II 1/21/2014 M/S ZCL CHEMICALS LTD D-THREO RITALINIC ACID HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
27932 A II 1/21/2014 ZCL CHEMICALS LTD THREO PHENYL-2- PIPERIDYL ACETAMIDE AS MANUFACTURED IN GUJARAT, INDIA
Page 844
4Q2012 2Q2014EXCEL
27933 A II 2/4/2014 MICRO LABS LTD ARTEMETHER (ESUB) AS MANUFACTURED IN BANGALORE, INDIA.
27934 A IV 1/13/2014 EMERSON RESOURCES INC PLASACRYL HTP20 AS MANUFACTURED IN NORRISTOWN, PA
27935 A II 6/27/2014 LABORCHEMIE APOLDA GMBH D-PENICILLAMINE (NEEDLES) (ESUB) AS MANUFACTURED IN THURINGIA, GERMANY
27936 A III 1/15/2014 AL CAN EXPORTS PVT LTD ALUMINIUM CONTAINERS AS MANUFACTURED IN MAHARASHTRA, INDIA
27937 A III 1/22/2014 CONSOLIDATED BOTTLE CORP 60ML WHITE HDPE ROUND 38/400 HEAVY WEIGHT [013917] AS MANUFACTURED IN
ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION
27938 A II 1/24/2014 ZHEJIANG WILD WIND PHARMACEUTICAL
CO LTD
LEVODOPA AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
27939 A II 4/2/2014 CADILA HEALTHCARE LTD MESALAMINE USP (PROCESS-II) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27940 A III 1/15/2014 AMPACET CORP 463935 BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
27941 A IV 1/14/2014 UNGERER AND CO 375620 METHYL SALICYLATE SYNTHETIC AS MANUFACTURED IN BETHLEHEM, PA
27942 A IV 1/15/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30619798 NAT FL MOD (MASKING) FMT ? SD AS MANUFACTURED IN CLARK, NJ
27943 A IV 1/6/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30617089 NAT FL MOD (MOUTHFEEL) FMT ? AS MANUFACTURED IN CLARK, NJ
27944 A IV 12/16/2013 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30619722 NAT FL MOD (SWEET) FMT ? PWD AS MANUFACTURED IN CLARK, NJ
27945 A II 4/13/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD ULIPRISTAL ACETATE (ESUB) AS MANUFACTURED IN VERCELLI, ITALY FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD
27946 A II 3/12/2014 IPCA LABORATORIES LTD TELMISARTAN USP (ESUB) AS MANUFACTURED IN
MADHYA PRADESH, INDIA
27947 A II 2/26/2014 DR REDDYS LABORATORIES LTD VORICONAZOLE, USP (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
27948 A IV 1/21/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30620292 NAT FL MODULATOR (MASKING) FMT ? PWD AS MANUFACTURED IN CLARK, NJ
27949 A IV 1/20/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30617086 NAT FL MODULATOR (MASKING) FMT ? AS MANUFACTURED IN CLARK, NJ
27950 A II 1/28/2014 DIVIS LABORATORIES LTD OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27951 A II 1/29/2014 IRVINE SCIENTIFIC SALES CO L-GLUTAMINE (200MM)- LIQUID AS MANUFACTURED IN SANTA ANA, CA
27952 A II 1/29/2014 IRVINE SCIENTIFIC SALES CO NON-ESSENTIAL AMINO ACIDS 100X FOR MEM-LIQUID AS MANUFACTURED IN SANTA
ANA, CA
27953 A II 3/18/2014 ITF CHEMICAL LTDA AZACYTIDINE (ESUB) AS MANUFACTURED IN HUBEI, P. R. OF CHINA FOR ITF CHEMICAL
LTDA
27954 A II 3/13/2014 MYLAN LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I) (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
27955 A II 2/12/2014 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
PREGABALIN (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
27956 A II 4/11/2014 AARTI INDUSTRIES LTD MOMETASONE FUROATE MONOHYDRATE (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
27957 A III 1/20/2014 YABAO PHARMACEUTICAL GROUP CO LTD HDPE BOTTLE AND CHILD-RESISTANT CLOSURE AS MANUFACTURED IN SHANXI, CHINA
27958 A II 5/30/2014 EMCURE PHARMACEUTICALS LTD IRON SUCROSE COMPLEX SOLUTION (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
27959 A II 2/13/2014 AUROBINDO PHARMA LTD DEXTROMETHORPHAN HYDROBROMIDE USP (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
27960 A II 4/4/2014 DR REDDYS LABORATORIES LTD DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA Page 845
4Q2012 2Q2014EXCEL
27961 A III 1/31/2014 TAKEUCHI PRESS INDUSTRIES CO LTD TAKEUCHI 4317F TUBE AS MANUFACTURED IN HYOGO, JAPAN
27962 A III 1/31/2014 FORMOSA PLASTICS CORP PP DIV TAISOX POLYETHYLENE RESINS AS MANUFACTURED IN TAIWAN, R.O.C.
27963 A II 4/11/2014 LUPIN LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27964 A II 1/31/2014 EGIS PHARMACEUTICALS PUBLIC LTD CO AMLODIPINE BESYLATE API AS MANUFACTURED IN BUDAPEST, HUNGARY
27965 P *** PENDING FILING REVIEW ***
27966 A II 3/12/2014 SINOPHARM WEIQIDA PHARMACEUTICAL
CO LTD
CLAVULANATE POTASSIUM Diluted 1:1 with Silicon Dioxide (ESUB) AS MANUFACTURED IN
SHANXI, CHINA
27967 A II 3/5/2014 LAURUS LABS PRIVATE LTD THALIDOMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27968 A IV 1/30/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
709932 N & A TROPICAL PUNCH FL AS MANUFACTURED IN CLARK, NJ
27969 A II 3/17/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD RALOXIFENE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN VERCELLI, ITALY FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD.
27970 A II 2/20/2014 HETERO DRUGS LTD LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27971 A II 1/20/2014 BASELL POLIOLEFINE ITALIA SRL CEFEPIME HYDROCHLORIDE STERILE AS MANUFACTURED IN VILLADOSE ROME, ITALY
27972 A II 2/12/2014 GLAND PHARMA LTD REGADENOSON (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27973 A II 5/28/2014 FERMION OY ODM-201 AS MANUFACTURED IN HANKO, FINLAND
27974 A III 2/4/2014 BASELL POLIOLEFINE ITALIA SRL PURELL ACP 5531 B AS MANUFACTURED IN MUNCHSMUNSTER, GERMANY FOR BASELL
POLIOLEFINE ITALIA S.R.L.
27975 P *** PENDING FILING REVIEW ***
27976 A II 3/18/2014 SINOPHARM WEIQIDA PHARMACEUTICAL
CO LTD
CLAVULANATE POTASSIUM DILUTED 1:1 WITH MICROCRYSTALLINE CELLULOSE (ESUB)
AS MANUFACTURED IN SHANXI, CHINA
27977 A II 6/27/2014 D K PHARMACHEM PVT LTD FENOFIBRATE USP (PROCESS B) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27978 A II 2/20/2014 INTAS PHARMACEUTICALS LTD CABAZITAXEL (AMORPHOUS) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
27979 A II 3/14/2014 ORIL INDUSTRIE IVABRADINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN BOLBEC, FRANCE
27980 A II 3/14/2014 ORIL INDUSTRIE AZEPAN (ESUB) AS MANUFACTURED IN BOLBEC, FRANCE
27981 A II 3/14/2014 LABORATORIOS SERVIER SL BUTAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TOLEDO, SPAIN
27982 A II 2/18/2014 CRYSTAL PHARMA SAU ALCAFTADINE (ESUB) AS MANUFACTURED IN VALLADOLID, SPAIN
27983 A II 3/28/2014 APOTEX PHARMACHEM INDIA PVT LTD FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA
27984 N NOT AN ASSIGNED NUMBER
27985 A III 2/14/2014 DSM ENGINEERING PLASTICS EUROPE B.V. ARNITE T06 202/A AS MANUFACTURED IN EMMEN, THE NETHERLANDS FOR DSM
ENGINEERING PLASTICS EUROPE B.V.
27986 A III 2/6/2014 GAPLAST GMBH DELAMINATING CO-EXTRUDED BAG-IN-BOTTLE SYSTEMS AS MANUFACTURED IN
SAULGRUB-ALTENAU, FEDERAL REPUBLIC OF GERMANY
27987 A IV 1/18/2014 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT HARD GELATIN CAPSULE SHELLS - PITHAMPUR AS MANUFACTURED IN
MADHYA PRADESH, INDIA
27988 A III 2/6/2014 GARDEN POLYMERS PVT LTD PET BOTTLES AS MANUFACTURED IN KARNATAKA, INDIA
27989 A II 2/12/2014 STERLING CHEMICAL MALTA LTD ABIRATERONE ACETATE AS MANUFACTURED IN BIRZEBBUGIA, MALTA AND PERUGIA,
ITALY FOR STERLING CHEMICAL MALTA LTD
27990 A II 3/1/2014 SUN PHARMACEUTICAL INDUSTRIES LTD OCTREOTIDE ACETATE (PROCESS-II) (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
27991 A II 3/11/2014 UNICHEM LABORATORIES LTD RIZATRIPTAN BENZOATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
27992 A II 2/28/2014 EGIS PHARMACEUTICALS PUBLIC LTD CO BUTAMINE HYDROCHLORIDE DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN
KERESZTURI UT, HUNGARY
Page 846
4Q2012 2Q2014EXCEL
27993 A II 5/19/2014 ALP PHARM BEIJING CO LTD ALOGLIPTIN BENZOATE (ESUB) AS MANUFACTURED IN HUBEI, CHINA FOR ALP PHARM
BEIJING CO LTD
27994 A III 2/18/2014 ARIFLEX SPA ALUMINIUM FOIL DRUG PACKAGING MATERIAL LACQUERED ON BOTH SIDES AS
MANUFACTURED IN SPINETTA MARENGO (AL), ITALY
27995 A II 2/24/2014 HUBEI GEDIAN HUMANWELL
PHARMACEUTICAL CO LTD
MEDROXYPROGESTERONE ACETATE (ESUB) AS MANUFACTURED IN HUBEI, P.R. CHINA
27996 N NOT AN ASSIGNED NUMBER
27997 A II 2/14/2014 HETERO LABS LTD DARUNAVIR ETHANOLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
27998 A II 2/10/2014 AK AND MN BIOFARM CO LTD AK & MN BIOFARM ICOSAPENTATE AS MANUFACTURED IN ULSAN, KOREA
27999 A III 2/14/2014 POLYONE CORP CC10187865XX (EX GREEN) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28000 A III 2/14/2014 POLYONE CORP CC10187864XX (EZ YELLOW) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28001 A III 2/14/2014 POLYONE CORP CC10187866XX (EZ RED) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28002 A III 2/14/2014 POLYONE CORP CC10187870XX (EZ ROYAL BLUE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28003 A III 2/14/2014 POLYONE CORP CC10187868XX (EZ BLACK) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28004 A III 2/14/2014 POLYONE CORP CC10187869XX (EZ LIGHT BLUE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28005 A III 2/14/2014 POLYONE CORP CC10187863XX (EX GREY) AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28006 A II 2/14/2014 IRVINE SCIENTIFIC SALES CO IS CHO-V IUF - POWDER AS MANUFACTURED IN SANTA ANA, CA
28007 A III 2/17/2014 DOWELL MOULDS PLASTIC BOTTLES, CAPS, JARS AND PLASTIC PACKAGING BLISTERS AS
MANUFACTURED IN GUJARAT, INDIA
28008 A II 6/5/2014 SIGNA SA DE CV LANTHANUM CARBONATE HYDRATE AS MANUFACTURED IN ESTADO DE MEXICO,
MEXICO
28009 A II 2/26/2014 MSN LABORATORIES PVT LTD APIXABAN [ROUTE CODE "AX"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28010 A II 2/26/2014 MSN LABORATORIES PVT LTD TOLVAPTAN [ROUTE CODE "TN"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28011 A II 3/3/2014 MSN LABORATORIES PVT LTD FORMOTEROL FUMARATE USP [ROUTE CODE "FL"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
28012 A II 3/3/2014 MSN LABORATORIES PVT LTD BEPOTASTINE BESILATE [ROUTE CODE - "BB"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
28013 A II 3/15/2014 MSN LABORATORIES PVT LTD ARFORMOTEROL TARTRATE [ROUTE CODE - "LT"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
28014 A II 3/3/2014 MSN PHARMACHEM PRIVATE LTD CLOPIDOGREL BISULFATE USP (FORM-1) [ROUTE CODE "CS1"] (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
28015 A II 4/10/2014 RAKS PHARMA PVT LTD LEVOMILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACATURED IN ANDHRA
PRADESH, INDIA
28016 P *** PENDING FILING REVIEW ***
28017 P *** PENDING FILING REVIEW ***
28018 A II 2/13/2014 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
VENLAFAXINE BASE AS MANUFACTURED IN ZHEJIANG, CHINA
28019 A III 2/4/2014 SORICH FOILS PVT LTD COATED/PLAIN/PRINTED ALUMINIUM FOIL, GLASSINE PAPER & LAMINATES,
PRINTED/PLAIN ALU-ALU FOIL, PRINTED/PLAIN CHILD RESISTANT FOIL (CR FOIL) FOR
PHARMACEUTICAL TABLET/CAPSULE PACKAGING AND FLEXIBLE PACKAGING FOR FOOD
INDUSTRY AS MANUFACTURED IN GUJARAT, INDIA
28020 A II 2/19/2014 SHASUN PHARMACEUTICALS LTD CELECOXIB, USP AS MANUFACTURED IN CUDDALORE, INDIA
28021 P *** PENDING FILING REVIEW ***
28022 A II 5/8/2014 LEK PHARMACEUTICALS DD ROSUVASTATIN CALCIUM (PROCESS B) AS MANUFACTURED IN MENGES, SLOVENIA
Page 847
4Q2012 2Q2014EXCEL
28023 A II 3/21/2014 LEK PHARMACEUTICALS DD RAPAMYCIN AS MANUFACTURED IN MENGES, SLOVENIA
28024 A II 3/25/2014 DR REDDYS LABORATORIES LTD AGOMELATINE PHOSPHORIC ACID (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28025 A II 2/18/2014 HIKAL LTD VENLAFAXINE BASE AS MANUFACTURED IN KARNATAKA AND MAHARASHTRA, INDIA
28026 A II 2/19/2014 METROCHEM API PRIVATE LTD ESOMEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28027 A II 2/6/2014 RL FINE CHEM DOXYLAMINE SUCCINATE AS MANUFACTURED IN BANGALORE, INDIA
28028 A II 3/18/2014 MACLEODS PHARMACEUTICALS LTD ROSUVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28029 A II 3/28/2014 APOTEX PHARMACHEM INDIA PVT LTD DABIGATRAN ETEXILATE MESYLATE AS MANUFACTURED IN BANGALORE, INDIA
28030 A II 5/15/2014 GLAND PHARMA LTD ARGATROBAN MONOHYDRATE (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
28031 A II 3/7/2014 CRYSTAL PHARMA SAU LOTEPREDNOL ESTABONATE STERILE MICRONIZED (ESUB) AS MANUFACTURED IN
VALLADOLID, SPAIN
28032 A IV 2/18/2014 EMILIO CASTELLI SAS SUGAR SPHERES NF AS MANUFACTURED IN BOVISIO MASCIAGO (MB) ITALY
28033 A II 12/23/2013 ZHEJIANG STARRY PHARMACEUTICAL CO
LTD
IOPAMIDOL AS MANUFACTURED IN ZHEJIANG, CHINA
28034 A II 2/21/2014 SIFAVITOR SRL LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN FRAZIONE MAIRANO (LO),
ITALY
28035 A II 2/18/2014 TAKASAGO INTERNATIONAL CORP RHA AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN
28036 A III 2/17/2014 EI DUPONT DE NEMOURS AND CO INC 320G-201 ONE COAT CLEAR AS MANUFACTURED IN MECHELEN, BELGIUM FOR E.I.
DUPONT DE NEMOURS & CO., INC.
28037 P *** PENDING FILING REVIEW ***
28038 A II 3/27/2014 DR REDDYS LABORATORIES LTD ABIRATERONE ACETATE (ESUB) AS MANUFACTURED IN MORELOS, MEXICO FOR DR.
REDDY'S LABORATORIES LIMITED
28039 A II 4/11/2014 LUPIN LTD DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28040 A II 4/30/2014 CODY LABORATORIES INC MORPHINE SULFATE, USP (ESUB) AS MANUFACTURED IN CODY, WYOMING
28041 A II 6/27/2014 CODY LABORATORIES INC HYDROCODONE BITARTRATE, USP (ESUB) AS MANUFACTURED IN CODY, WYOMING
28042 A III 2/14/2014 DURAN GROUP GMBH DURAN BOROSILICATE GLASS 3.3 CONTAINERS CLEAR GLASS AND AMBER
COLOURED GLASS AS MANUFACTURED IN MAINZ, GERMANY; WERTHEIM/MAIN,
GERMANY AND PULA, CROATIA FOR DURAN GROUP GMBH
28043 A II 3/8/2014 UMICORE ARGENTINA SA OXALIPLATIN (ESUB) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA
28044 A III 2/14/2014 DURAN GROUP GMBH DURAN? CLOSURES MADE FROM PFA WITHOUT AND WITH SEALING DISC AS
MANUFACTURED IN OESTRICH-WINKEL, GERMANY AND HILDESHEIM, GERMANY FOR
DURAN GROUP GMBH
28045 A II 2/18/2014 SKUNY BIOSCIENCE CO LTD OMEGA-3-ACID ETHYL ESTERS 90 AS MANUFACTURED IN SICHUAN, P.R. CHINA
28046 A II 3/9/2014 UMICORE ARGENTINA SA CISPLATIN (ESUB) AS MANUFACTURED IN BUENOS AIRES PROVINCE, ARGENTINA
28047 A II 3/10/2014 UMICORE ARGENTINA SA CARBOPLATIN (ESUB) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA
28048 A II 3/12/2014 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DECITABINE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
28049 A II 3/7/2014 JUBILANT LIFE SCIENCES LTD GUANFACINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
28050 A II 3/31/2014 JUBILANT LIFE SCIENCES LTD ALISKIREN HEMIFUMARATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
28051 A II 5/5/2014 CIPLA LTD CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28052 A II 3/28/2014 JUBILANT LIFE SCIENCES LTD DEXLANSOPRAZOLE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
Page 848
4Q2012 2Q2014EXCEL
28053 A II 3/29/2014 JUBILANT LIFE SCIENCES LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (ESUB) AS MANUFACTURED IN
KARNATAKA, INDIA
28054 A II 3/29/2014 JUBILANT LIFE SCIENCES LTD ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP (ESUB) AS MANUFACTURED IN
KARNATAKA, INDIA
28055 A II 3/28/2014 WISDOM PHARMCEUTICAL CO LTD BENDAMUSTINE INTERMEDIATE (EUSB) AS MANUFACTURED IN JIANGSU, CHINA
28056 A II 3/28/2014 ALEMBIC PHARMACEUTICALS LTD RIVAROXABAN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28057 A II 3/28/2014 ALEMBIC PHARMACEUTICALS LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28058 A II 3/28/2014 ALEMBIC LTD LOVASTATIN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28059 A II 3/28/2014 UNICHEM LABORATORIES LTD CETIRIZINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA
28060 A II 3/28/2014 UNICHEM LABORATORIES LTD PIROXICAM USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28061 A II 2/21/2014 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
BCK (4-NITROBENZYL(5R,6S)-6-[(1R)-1- HYDROXYETHYL]-3,7-DIOXO-1-
AZABICYCLO[3.2.0]HEPTANE-2-CARBOXYLATE) AS MANUFACTURED IN ZHEJIANG
PROVINCE, P.R. CHINA
28062 A II 2/28/2014 HETERO DRUGS LTD METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28063 A II 2/26/2014 IRVINE SCIENTIFIC SALES CO PBS 1X DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION-LIQUID AS
MANUFACTURED IN SANTA ANA, CA
28064 A II 2/26/2014 IRVINE SCIENTIFIC SALES CO HEPES BUFFER SOLUTION 1M-LIQUID AS MANUFACTURED IN SANTA ANA, CA
28065 A II 3/17/2014 APOTEX FERMENTATION INC TACROLIMUS AS MANUFACTURED IN MANITOBA, CANADA
28066 A II 2/28/2014 HENAN LIHUA PHARMACEUTICAL CO LTD HYDROCORTISONE AS MANUFACTURED IN HENAN, CHINA
28067 A III 2/19/2014 BORMIOLI ROCCO SPA BU PHARMA PLASTIC BOTTLE LDPE 15 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO
(PV), ITALY AND SAINT SULPICE, FRANCE
28068 A IV 3/5/2014 FONA INTERNATIONAL INC 856.0232U GRAPE TYPE FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
28069 A II 2/25/2014 JINGMEN SHUAIBANG CHEMICAL SCIENCE
AND TECHNOLOGY CO LTD
TENOFOVIR (DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN HUBEI
PROVINCE, P.R. CHINA
28070 P *** PENDING FILING REVIEW ***
28071 A II 3/20/2014 MSN LABORATORIES PVT LTD MIRABEGRON [ROUTE CODE "MG"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28072 A II 3/22/2014 MSN PHARMACHEM PRIVATE LTD VILAZODONE HYDROCHLORIDE [ROUTE CODE "VN"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
28073 A II 3/24/2014 MSN ORGANICS PRIVATE LTD RIVASTIGMINE TARTRATE USP [ROUTE CODE "RM"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
28074 A IV 3/5/2014 ZHONGSHAN CAPSULE STARCH MATERIAL
TECHNOLOGY CO LTD
PREGELATINIZED HYDROXYPROPYL STARCH AS MANUFACTURED IN GUANGDONG,
CHINA
28075 A II 3/6/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD BUPRENORPHINE AS MANUFACTURED IN KOMAROV, CZECH REPUBLIC FOR TEVA
PHARMACEUTICAL INDUSTRIES LTD.
28076 A II 4/21/2014 APOTEX PHARMACHEM INDIA PVT LTD LURASIDONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA
28077 A II 4/10/2014 HOUSTON CYCLOTRON PARTNERS LP FLUOROLEVODOPA F 18 INJECTION (6-[18F]FLUORO-L-DOPA) AS MANUFACTURED IN
HOUSTON, TEXAS
28078 A II 3/18/2014 EMCURE PHARMACEUTICALS LTD DEXMEDETOMIDINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
28079 P *** PENDING FILING REVIEW ***
28080 A IV 3/5/2014 CI FARMACAPSULAS SA ACID RESISTANT CAPSULES (AR CAPS ) AS MANUFACTURED IN BARRANQUILLA,
COLOMBIA
28081 A IV 2/26/2014 GM CHEMIE PVT LTD HYPROMELLOSE PHTHALATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
Page 849
4Q2012 2Q2014EXCEL
28082 A IV 3/4/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30623270 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK,
NEW JERSEY
28083 A IV 3/4/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30623266 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK,
NEW JERSEY
28084 P *** PENDING FILING REVIEW ***
28085 A II 5/2/2014 CIPLA LTD DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28086 A II 3/25/2014 MSN LABORATORIES PVT LTD DAPAGLIFLOZIN PROPANEDIOL [ROUTE CODE "DQ"] (ESUB) AS MANUFACTURED IN
ANDHRA PRADESH, INDIA
28087 A II 3/31/2014 CIPLA LTD MONTELUKAST SODIUM USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
28088 P *** PENDING FILING REVIEW ***
28089 A III 2/19/2014 QUALITY PLASTICS LLC POLYETHYLENE BOTTLES AS MANUFACTURED IN PRESCOTT, ARIZONA
28090 A II 3/10/2014 SRIKEM LABORATORIES PVT LTD PERMETHRIN AS MANUFACTURED IN NAVI MUMBAI, INDIA
28091 A II 4/1/2014 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
PAROXETINE MESYLATE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
28092 A II 3/27/2014 MSN LABORATORIES PVT LTD AZILSARTAN KAMEDOXOMIL [ROUTE CODE "AK"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
28093 A II 3/26/2014 MSN LABORATORIES PVT LTD ACLIDINIUM BROMIDE [ROUTE CODE "AU"] (ESUB) AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
28094 A II 3/26/2014 MSN LABORATORIES PVT LTD PEMETREXED DISODIUM HEPTAHYDRATE [ROUTE CODE "PT"] (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
28095 A II 3/27/2014 MSN LABORATORIES PVT LTD AVANAFIL [ROUTE CODE "AV"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28096 A II 3/28/2014 MSN LABORATORIES PVT LTD RIFAXIMIN [ROUTE CODE "RX"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28097 A II 3/28/2014 MSN LABORATORIES PVT LTD RIFAXIMIN [ROUTE CODE "RFa"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28098 A II 3/28/2014 MSN PHARMACHEM PRIVATE LTD LINAGLIPTIN [ROUTE CODE "LG"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28099 A II 3/28/2014 MSN LABORATORIES PVT LTD PEMETREXED DISODIUM HEMIPENTAHYDRATE [ROUTE CODE "PN"] (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
28100 A II 4/5/2014 MSN LABORATORIES PVT LTD AZACITIDINE [ROUTE CODE "AJ"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28101 A II 4/1/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD CABAZITAXEL (ESUB) AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC FOR
TEVA PHARMACEUTICAL INDUSTRIES LTD
28102 P *** PENDING FILING REVIEW ***
28103 A IV 3/12/2014 GUANGDONG YUE ER KANG
PHARMACEUTICAL CO LTD
HYDROXYPROPYL STARCH VACANT CAPSULE AS MANUFACTURED IN GUANGDONG,
CHINA
28104 A III 3/11/2014 BINNY WADS PVT LTD EPE (EXPANDED POLYETHYLENE) LINERS/SHEET AS MANUFACTURED IN HARYANA,
INDIA
28105 A II 3/20/2014 TYCHE INDUSTRIES LTD NEVIRAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28106 A II 3/13/2014 FINE CHEMICALS CORP PTY LTD REMIFENTANIL HYDROCHLORIDE AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA
28107 A II 3/12/2014 POLYMED THERAPEUTICS INC AZACITIDINE USP AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED
THERAPEUTICS, INC.
28108 A II 3/24/2014 MICRO LABS LTD LUMEFANTRINE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
28109 A II 1/15/2014 JIAOZUO JOINCARE BIOTECHNOLOGICAL
CO LTD
D-7ACA AS MANUFACTURED IN HENAN, P.R. CHINA
Page 850
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28110 A II 2/20/2014 KAIYUAN HENGTAI PHARMA CO LTD TICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R, 6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO-
3AH-CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY) ETHANOL L-TARTARIC ACID (1:1)
(CAS:376608-65-0) AS MANUFACTURED IN LIAONING PROVINCE, P.R. CHINA
28111 A II 2/20/2014 KAIYUAN HENGTAI PHARMA CO LTD TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS:
145783-15-9) AS MANUFACTURED IN LIAONING PROVINCE, P.R. CHINA
28112 A II 2/20/2014 KAIYUAN HENGTAI PHARMA CO LTD TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE
(R)-2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8) AS MANUFACTURED IN
LIAONING PROVINCE, P.R. CHINA
28113 A III 3/14/2014 POLYONE CORP T270.0 AS MANUFACTURED IN BETHEL, CONNECTICUT FOR POLYONE CORP.
28114 A III 3/14/2014 POLYONE CORP T270.5 AS MANUFACTURED IN BETHEL, CONNECTICUT FOR POLYONE CORPORATION
28115 A III 3/14/2014 POLYONE CORP T623.8 AS MANUFACTURED IN LAND, FINLAND FOR POLYONE CORPORATION
28116 A III 3/12/2014 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN B25026 BLUE 279C AND G27947 COOL GREY 6C COLORANT
MASTERBATCHES AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG,
SC
28117 A II 2/9/2014 WEINAN HIGH TECH NEW ELECTRONIC
CHEMICAL CO LTD
P-[[(1S)-2-[4-(BENZOYLAMINO)-2-OXO-1(2H)-PYRIMIDINYL]-1-
(HYDROXYMETHYL)ETHOXY]METHYL]PHOSPHONIC ACID DIETHYL ESTER AS
MANUFACTURED IN SHANXI PROVINCE, CHINA
28118 A II 4/27/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH,
INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
28119 A II 4/16/2014 MEDICHEM SA MED-300179/E (INTERMEDIATE) (ESUB) AS MANUFACTURED IN CELRA (GIRONA), SPAIN
28120 A II 4/4/2014 CHEMISCHE FABRIK BERG GMBH METHENAMINE HIPPURATE AS MANUFACTURED IN BITTERFELD-WOLFEN, GERMANY
28121 A II 3/31/2014 DR REDDYS LABORATORIES LTD RIVAROXABAN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28122 A II 4/16/2014 CADILA PHARMACEUTICALS LTD ATORVASTATIN CALCIUM FORM-I (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28123 A II 3/18/2014 SHASUN PHARMACEUTICALS LTD PREGABALIN AS MANUFACTURED IN CUDDALORE, INDIA
28124 A II 3/17/2014 SYMBIOTEC PHARMALAB LTD DESOGESTREL EP/BP, MICRONIZED AS MANUFACTURED IN MADHYA PRADESH, INDIA
28125 A II 3/17/2014 STERLING SPA NOMEGESTROL ACETATE CODE 204622 AS MANUFACTURED IN PERUGIA, ITALY
28126 A II 4/18/2014 MYLAN LABORATORIES LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28127 A II 3/31/2014 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM [AMORPHOUS] [PRODUCT CODE: ADR] (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
28128 A II 3/31/2014 RAKS PHARMA PVT LTD RITONAVIR, USP (FORM-I) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28129 A II 4/1/2014 CIPLA LTD ATAZANAVIR SULPHATE (METHANOL ROUTE) (ESUB) AS MANUFACTURED IN
MAHARASHTRA, INDIA
28130 A IV 3/18/2014 HENKEL CORP GELVA GMS 3087 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
28131 A IV 3/20/2014 FONA INTERNATIONAL INC 807.174 MIXED BERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, ILLINOIS
28132 A II 3/24/2014 CEDARBURG PHARMACEUTICALS INC BULK ETHANOLAMINE OLEATE API IN SOLUTION AS MANUFACTURED IN GRAFTON,
WISCONSIN
28133 A II 4/17/2014 BEIJING HUIKANG BOYUAN CHEMICAL TECH
CO LTD
VILDAGLIPTIN (ESUB) AS MANUFACTURED IN BEIJING, CHINA
28134 A II 4/2/2014 INDOCO REMEDIES LTD BRINZOLAMIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28135 A II 3/31/2014 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE [PRODUCT CODE: ERM] (ESUB) AS
MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 851
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28136 A IV 3/13/2014 TAKASAGO INTERNATIONAL CORP PUMA WHIZZLE - FLAVOUR TEG - 10353526 AS MANUFACTURED IN ZULPICH, GERMANY
FOR TAKASAGO INTERNATIONAL CORPORATION
28137 A II 3/20/2014 SYMBIOTEC PHARMALAB LTD BECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED) AS
MANUFACTURED IN MADHYA PRADESH, INDIA
28138 A IV 3/20/2014 PHARMA 73 SA HPE 1 - CHITIN GLUCAN COMPLEX AS MANUFACTURED IN CASTANHEIRA DO RIBATEJO,
PORTUGAL FOR PHARMA 73, S.A.
28139 A II 4/18/2014 CADILA PHARMACEUTICALS LTD CARVEDILOL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28140 A II 3/31/2014 KD PHARMA BEXBACH GMBH EPA 550/DHA 200 FFA (ESUB) AS MANUFACTURED IN BEXBACH, GERMANY AND
HOMBURG, GERMANY
28141 A V 4/29/2014 PHARMALUCENCE INC STERILE PROCESSING FACILITY
28142 A II 4/23/2014 TAI HENG INDUSTRY CO LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN SHANGHAI, P. R. CHINA
28143 A III 3/24/2014 MINNESOTA RUBBER AND PLASTICS 914M, A FLUOROELASTOMER RUBBER FOR SEALING AND OTHER MEDICAL-RELATED
APPLICATIONS IN MEDICAL DEVICES AS MANUFACTURED IN LITCHFIELD, MINNESOTA
28144 A II 3/29/2014 PIRAMAL ENTERPRISES LTD PERINDOPRIL ERBUMINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28145 A III 3/17/2014 AMPACET CORP 10053-K AMSTAT 53 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET
CORPORATION
28146 A II 4/9/2014 TYCHE INDUSTRIES LTD TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28147 A III 3/17/2014 AMPACET CORP 4500166-N PINK PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA,
CARTERSVILLE, GA AND HEATH, OH
28148 A II 4/27/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN OPAVA - KOMAROV,
CZECH REPUBLIC AND UTTAR PRADESH, INDIA FOR TEVA PHARMACEUTICAL
INDUSTRIES LTD
28149 A II 4/23/2014 MACLEODS PHARMACEUTICALS LTD FEBUXOSTAT (ESUB) AS MANUFACTURED IN GUJRAT, INDIA
28150 A III 3/26/2014 FONA INTERNATIONAL INC 822.0174U CARAMEL MAILLARD FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
28151 A II 3/27/2014 REVIMMUNE INC CYT107 AS MANUFACTURED IN PRINCETON, NJ FOR REVIMMUNE, INC.
28152 A III 3/28/2014 ARIFLEX SPA COLD FORMABLE FOIL LAMINATE AS MANUFACTURED IN SPINETTA MARENGO (AL),
ITALY
28153 P *** PENDING FILING REVIEW ***
28154 A III 4/4/2014 INDIAN OIL CORP LTD PROPEL HDPE 180M50 (ESUB) AS MANUFACTURED IN HARYANA, INDIA
28155 A IV 3/24/2014 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT CELLULOSE CAPSULE SHELLS AS MANUFACTURED IN MADHYA PRADESH,
INDIA
28156 A II 3/27/2014 SHASUN PHARMACEUTICALS LTD CINACALCET HYDROCHLORIDE AS MANUFACTURED IN PUDUCHERRY, INDIA
28157 A II 6/12/2014 MERCK KGAA SAFINAMIDE METHANESULFONATE (ESUB) AS MANUFACTURED IN DARMSTADT,
GERMANY
28158 A II 5/15/2014 MAPRIMED SA FLECAINIDE ACETATE PROCESS III (CODE 50970) AS MANUFACTURED IN BUENOS AIRES,
ARGENTINA
28159 A II 4/21/2014 HETERO LABS LTD CABAZITAXEL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28160 A II 4/4/2014 CHEMCON GMBH SODIUM NITROPRUSSIDE DIHYDRATE (ESUB) AS MANUFACTURED IN FREIBURG IM
BREISGAU, GERMANY
28161 A II 12/26/2013 PERRIGO API LTD TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN BEER SHEVA, ISRAEL
28162 A II 5/30/2014 SHILPA MEDICARE LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
28163 A II 3/27/2014 PERRIGO API LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN BEER SHEVA, ISRAEL
28164 A II 4/22/2014 TORRENT PHARMACEUTICALS LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
Page 852
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28165 A II 4/23/2014 HEC PHARM CO LTD FINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (ESUB) AS
MANUFACTURED IN GUANGDONG PROVINCE, P.R. CHINA FOR HEC PHARM CO., LTD
28166 A III 3/27/2014 AMPACET CORP 113099 BLUE WHITE SLIP PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER,
LA; CARTERSVILLE, GA AND HEATH, OH
28167 A III 3/18/2014 TEKNOR COLOR CO 16,386HCPP MAGENTA 227C 50:1 AS MANUFACTURED IN HENDERSON, KY
28168 A II 3/31/2014 IRVINE SCIENTIFIC SALES CO RPMI MEDIUM 1640 - LIQUID AS MANUFACTURED IN SANTA ANA, CALIFORNIA
28169 A II 3/31/2014 IRVINE SCIENTIFIC SALES CO PBS 1X DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION WITHOUT CALCIUM AND
MAGNESIUM SALTS - LIQUID AS MANUFACTURED IN SANTA ANA, CALIFORNIA
28170 A II 3/28/2014 CHEMPORT INC E550D200FFA (OMEGA-3-POLYUNSATURATED FREE FATTY ACIDS) AS MANUFACTURED
IN SOUTH JEOLLA PROVINCE, KOREA
28171 A II 4/1/2014 SYMED LABS LTD ESZOPICLONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28172 A III 4/11/2014 ALPHAMED BOTTLES INC CLOSURES (ESUB) AS MANUFACTURED IN HAUPPAUGE, NEW YORK
28173 A II 4/14/2014 LUPIN LTD EZETIMIBE (PROCESS B) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28174 A III 4/1/2014 POLYONE CORP CC00012728XX AS MANUFACTURED IN ELK GROVE VILLAGE, IL
28175 A II 5/15/2014 PAR PHARMACEUTICAL INC FERRIC CITRATE (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA FOR PAR
PHARMACEUTICAL, INC.
28176 A II 4/18/2014 PAR PHARMACEUTICAL INC TIZANIDINE HYDROCHLORIDE, USP (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA
FOR PAR PHARMACEUTICAL, INC
28177 P *** PENDING FILING REVIEW ***
28178 A II 4/28/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO
CROATIA FOR TEVA PARMACEUTICAL INDUSTRIES LTD
28179 A III 4/4/2014 ARTE CORP DUAL CHAMBER PREFILLABLE SYRINGE WITH CAP (WITHOUT NEEDLE) AS
MANUFACTURED IN IBARAKI PREFECTURE, JAPAN
28180 A II 4/2/2014 KATAYAMA SEIYAKU CO LTD LULICONAZOLE AS MANUFACTURED IN TOYAMA, JAPAN
28181 A III 4/3/2014 AMPACET CORP 151249 RED HDPE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
28182 A II 5/18/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD IMATINIB MESYLATE FORM ALPHA (ESUB) AS MANUFACTURED IN PRIGORJE
BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD
28183 A III 3/15/2014 INNOVOPAK INC POLY-PROPYLENE DOSAGE CUP AS MANUFACTURED IN ONTARIO, CANADA
28184 P *** PENDING FILING REVIEW ***
28185 A IV 4/2/2014 TAKASAGO INTERNATIONAL CORP TOOTHPASTE FLAVOR F-91250 AS MANUFACTURED IN SHIZIOKA, JAPAN
28186 A III 4/7/2014 POLYLAB INTERNATIONAL PLASTIC CONTAINERS FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN
KUNDLI (HARYANA), INDIA
28187 A II 4/24/2014 BEIJING HUIKANG BOYUAN CHEMICAL TECH
CO LTD
ALOGLIPTIN BENZOATE (ESUB) AS MANUFACTURED IN BEIJING, CHINA
28188 A IV 4/7/2014 ANTARES HEALTH PRODUCTS INC ANTARES VITAMIN E TPGS, NF GRADE AS MANUFACTURED IN DOUGLAS, GA FOR
ANTARES HEALTH PRODUCTS INC.
28189 A IV 4/8/2014 FONA INTERNATIONAL INC 815.0084U BUBBLE GUM FLAVOR ART AS MANUFACTURED IN GENEVA, IL
28190 A II 6/26/2014 BAYER PHARMA AG AZELAIC ACID (A) (ESUB) AS MANUFACTURED IN BERGKAMEN, GERMANY
28191 A II 5/15/2014 CORDEN PHARMA LATINA SPA CEFEPIME/L-ARGININE STERILE BLEND (ESUB) AS MANUFACTURED IN SERMONETA
(LATINA), ITALY
28192 P *** PENDING FILING REVIEW ***
28193 A II 6/16/2014 APICORE LLC PHENTOLAMINE MESYLATE, USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR
APICORE LLC
28194 A II 6/15/2014 APICORE LLC TETRABENAZINE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
Page 853
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28195 A III 3/31/2014 BASELL POLIOLEFINE ITALIA SRL PURELL RP315M AS MANUFACTURED IN FERRARA, ITALY
28196 A II 4/10/2014 NOF CORP [A-METHOXY-W-AMINOPROPYL, POLY (OXYETHYLENE)]-BLOCK-POLY (L-SODIUM
GLUTAMATE) AS MANUFACTURED IN KANAGAWA PREFECTURE, JAPAN
28197 P *** PENDING FILING REVIEW ***
28198 A IV 3/27/2014 ANHUI SUNHERE PHARMACEUTICAL
EXCIPIENTS CO LTD
SODIUM STARCH GLYCOLATE TYPE A AS MANUFACTURED IN ANHUI, P.R. CHINA
28199 A II 4/10/2014 VIWIT PHARMACEUTICAL CO LTD RIVAROXABAN (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN SHANGHAI,
CHINA
28200 A II 4/18/2014 ALP PHARM BEIJING CO LTD DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA FOR
ALP PHARM BEIJING CO., LTD
28201 P *** PENDING FILING REVIEW ***
28202 A III 4/10/2014 COLORTECH INC 10868-18 SLIP/ANTIBLOCK POLYETHYLENE CONCENTRATE AS MANUFACTURED IN
MORRISTOWN, TENNESSEE AND ONTARIO, CANADA
28203 A IV 4/14/2014 ABELEI INC 148A76 NATURAL GRAPE TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA,
ILLINOIS
28204 P *** PENDING FILING REVIEW ***
28205 P *** PENDING FILING REVIEW ***
28206 A II 5/21/2014 ASTRAZENECA LP METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE 25/12.5,50/12.5
AND100/12.5 TABLETS (ESUB) AS MANUFACTURED IN SODERTALJE, SWEDEN FOR
ASTRAZENECA LP
28207 A III 4/11/2014 SHANDONG DAWN POLYMER CO LTD THERMOPLASTIC VULCANIZATE FOR PHARMACEUTICAL STOPPERS AND SEALS AS
MANUFACTURED IN SHANDONG PROVINCE, CHINA
28208 A II 4/18/2014 AMOLI ORGANICS PVT LTD DICLOFENAC FREE ACID (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28209 A II 5/23/2014 CLAROCHEM IRELAND LTD CL1109 (ESUB) AS MANUFACTURED IN DUBLIN, IRELAND
28210 A II 4/25/2014 UNIMARK REMEDIES LTD DORIPENEM CRUDE (INTERMEDIATE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28211 A II 4/30/2014 PAR PHARMACEUTICAL INC MIDODRINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA
FOR PAR PHARMACEUTICAL INC
28212 A II 5/3/2014 AURONEXT PHARMA PRIVATE LTD DORIPENEM MONOHYDRATE (STERILE) (ESUB) AS MANUFACTURED IN RAJASTHAN,
INDIA
28213 A III 4/14/2014 VERSALIS SPA PHARMALENE BC 82 PH AS MANUFACTURED IN BRINDISI, ITALY
28214 A III 4/14/2014 VERSALIS SPA PHARMALENE MP 90 PH AS MANUFACTURED IN BRINDISI, ITALY
28215 A III 4/14/2014 VERSALIS SPA RIBLENE FL 34 F AS MAUFACTURED IN DUNKERQUE, FRANCE
28216 P *** PENDING FILING REVIEW ***
28217 A II 4/21/2014 SYMED LABS LTD LANTHANUM CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28218 A III 4/10/2014 SONA EXTRUSION PRIVATE LTD ALUMINIUM COLLAPSIBLE TUBES AND CONTAINERS AS MANUFACTURED IN GUJARAT,
INDIA
28219 P *** PENDING FILING REVIEW ***
28220 P *** PENDING FILING REVIEW ***
28221 A II 5/6/2014 SYNBIAS PHARMA LTD VINORELBINE TARTRATE (ESUB) AS MANUFACTURED IN DONETSK, UKRAINE
28222 A II 5/30/2014 S AND B PHARMA INC DBA NORAC PHARMA SPB-10101 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CALIFORNIA
28223 P *** PENDING FILING REVIEW ***
28224 A III 4/17/2014 THE PAPER PRODUCTS LTD FLEXIBLE LAMINATES, POUCHES (IN 2PLY, 3PLY, 4PLY), SPECIALIZED CARTONS AND
LABELS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 854
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28225 A II 4/22/2014 HONOUR LAB LTD FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28226 P *** PENDING FILING REVIEW ***
28227 A IV 4/17/2014 HENKEL CORP GELVA GMS 788 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
28228 A II 4/21/2014 GULBRANDSEN TECHNOLOGIES INC ACHIEVE D 5490 CP AS MANUFACTURED IN GUJARAT, INDIA FOR GULBRANDSEN
TECHNOLOGIES INC.
28229 A IV 4/18/2014 MANE INC FLAVORINGS FOR PHARMACEUTICAL USE AS MANUFACTURED IN LEBANON, OHIO;
MILFORD, OHIO; WOODLAWN, OHIO AND BAR SUR LOUP, FRANCE
28230 P *** PENDING FILING REVIEW ***
28231 A II 5/27/2014 MEDICHEM MANUFACTURING MALTA LTD DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN HAL FAR, MALTA
28232 A III 4/27/2014 AMISHA VINYLS PVT LTD NON-TOXIC RIGID PVC FILM FOR PHARMACEUTICAL BLISTER PACKAGING, FOOD
PRODUCTS AND THERMOFORMING APPLICATIONS AS MANUFACTURED IN NANI DAMAN,
INDIA
28233 A IV 4/25/2014 PFANSTIEHL INC D-GALACTOSE, PLANT DERIVED, HIGH PURITY LOW ENDOTOXIN, USP/NF, EP (G-126-1) AS
MANUFACTURED IN WAUKEGAN, IL
28234 P *** PENDING FILING REVIEW ***
28235 A II 6/19/2014 EMCURE PHARMACEUTICALS LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28236 A IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30625750 NAT FL MODULATOR (MASKING) FMT AS MANUFACTURED IN CLARK, NEW
JERSEY
28237 A IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30625760 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK,
NEW JERSEY
28238 A IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30625759 NAT FL MOD (MASKING) FMT SD AS MANUFACTURED IN CLARK, NEW JERSEY
28239 A IV 4/21/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30627948 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK,
NEW JERSEY
28240 A IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30625761 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK,
NEW JERSEY
28241 A IV 4/21/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30627945 NAT FL MODULATOR (MASKING) FMT PWD AS MANUFACTURED IN CLARK,
NEW JERSEY
28242 A II 5/14/2014 URQUIMA SA ALBACONAZOLE AS MANUFACTURED IN BARCELONA, SPAIN
28243 A IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS DBA
MASTERTASTE INC
30625757 NAT FL MOD (MOUTHFEEL) FMT AS MANUFACTURED IN CLARK, NEW JERSEY
28244 A II 4/28/2014 ACEBRIGHT INDIA PHARMA PRIVATE LTD LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)] AS MANUFCTURED IN KARNATAKA, INDIA
28245 P *** PENDING FILING REVIEW ***
28246 A II 5/19/2014 SOLUTEX GC SL OMEGA-3-ACID ETHYL ESTERS (ESUB) AS MANUFACTURED IN MALLEN (ZARAGOZA),
SPAIN
28247 A II 6/16/2014 APICORE LLC FLUCYTOSINE, USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC
28248 A II 5/1/2014 NOF CORP MPEG5000DPPE (N-(METHOXYPOLYETHYLENEGLYCOLCARBAMOYL)-1,2-DIPALMITOYL-SN-
GLYCERO-3-PHOSPHATIDYL-ETHANOLAMINE,MONOSODIUM SALT) AS MANUFACTURED
IN HYOGO, JAPAN
28249 A III 4/30/2014 APEX PLASTICS INC 12OZ MILK OF MAGNESIA AS MANUFACTURED IN BROOKFIELD, MISSOURI
28250 A II 5/1/2014 IRVINE SCIENTIFIC SALES CO RPMI MEDIUM 1640 WITHOUT L-GLUTAMINE - LIQUID AS MANUFACTURED IN SANTA ANA,
CALIFORNIA
28251 P *** PENDING FILING REVIEW ***
Page 855
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28252 A II 6/4/2014 RAKS PHARMA PVT LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28253 A II 4/30/2014 IRVINE SCIENTIFIC SALES CO ALPHA MEM EARLE'S SALTS - LIQUID AS MANUFACTURED IN SANTA ANA, CA
28254 A II 4/25/2014 ZHEJIANG XIANJU JUNYE PHARMACEUTICAL
CO LTD
PRASTERONE ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA
28255 A II 4/28/2014 AUSTIN PHARMA LLC CANNABIDIOL AS MANUFACTURED IN ROUND ROCK, TX
28256 A II 5/2/2014 IBA MOLECULAR NORTH AMERICA INC 68GA-DOTA-TOC AS MANUFACTURED IN SOMERSET, NJ
28257 A III 4/29/2014 AZTEC TECHNOLOGIES MOISTURE AND ODOUR REGULATING PRODUCTS AS MANUFACTURED IN ANDHRA
PRADESH, INDIA
28258 A II 2/4/2014 FRESENIUS KABI ANTI INFECTIVES SRL CEFEPIME ARGININE STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY
28259 A IV 5/2/2014 FONA INTERNATIONAL INC 884.0107U N-C JUICY ORANGE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
28260 A II 5/30/2014 DR REDDYS LABORATORIES LTD VILAZODONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28261 A IV 6/19/2014 ALBANY MOLECULAR RESEARCH INC SODIUM TARTRATE, NF AS MANUFACTURED IN ALBANY, NY
28262 A II 6/23/2014 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
NILUTAMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT LTD
28263 P *** PENDING FILING REVIEW ***
28264 A II 6/6/2014 MYLAN LABORATORIES LTD FLUTICASONE PROPIONATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA
28265 A IV 5/6/2014 FONA INTERNATIONAL INC 815.0052U N-C BUBBLEGUM TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL
28266 A IV 5/6/2014 JAPAN CORN STARCH CO LTD GRASTAR AS MANUFACTURED IN AICHI, JAPAN
28267 A II 5/6/2014 ALCHYMARS ICM SM PRIVATE LTD 6-METHYLENE ANDROST-4-ENE-3, 17-DIONE (6-MAD) DRUG SUBSTANCE INTERMEDIATE
AS MANUFACTURED IN TAMIL NADU, INDIA
28268 A III 4/30/2014 HEINKE TECHNOLOGY INC MIXING SPATULA AS MANUFACTURED IN LINCOLN, NE
28269 A III 4/29/2014 3M DRUG DELIVERY SYSTEMS 3M PACKAGING FILM PF200M AS MANUFACTURED IN COTTAGE GROVE, MN; DECATUR,
AL AND HUTCHINSON, MN
28270 A III 4/30/2014 BORMIOLI ROCCO SPA BU PHARMA PLASTIC SYRINGE DOSING 5ML WITH COVER AS MANUFACTURED IN CASTELGUELFO (PR), ITALY;
RIVANAZZANO (PV), ITALY AND SAINT SULPICE, FRANCE
28271 A II 4/25/2014 SEWON CELLONTECH CO LTD ATELOCOLLAGEN POWDER AS MANUFACTURED IN SEOUL, KOREA
28272 A III 4/15/2014 ROY AND LECLAIR EMBALLAGE INC INJECTION MOLDED COMPONENTS AS MANUFACTURED IN QUEBEC, CANADA FOR
ROY+LECLAIR EMBALLAGE INC.
28273 A II 5/5/2014 BACHEM AMERICAS INC LINACLOTIDE (BULK) AS MANUFACTURED IN TORRANCE, CALIFORNIA
28274 A IV 5/6/2014 WEI MING PHARMACEUTICAL MFG CO LTD CYCLOCEL (MICROCRYSTALLINE CELLULOSE, NF/EP) AS MANUFACTURED IN TAIWAN,
R. O. CHINA
28275 A II 5/6/2014 LIVZON GROUP FUZHOU FUXING
PHARMACEUTICAL CO LTD
KANAMYCIN SULFATE AS MANUFACTURED IN FUJIAN PROVINCE, P.R. CHINA
28276 A II 6/11/2014 BIOCON LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
28277 A II 5/8/2014 NEULAND LABORATORIES LTD ALCAFTADINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28278 A II 6/11/2014 CADILA HEALTHCARE LTD FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28279 A II 6/7/2014 UNIMARK REMEDIES LTD MEROPENEM USP (STERILE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28280 A II 5/30/2014 UNIMARK REMEDIES LTD DORIPENEM STERILE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28281 A II 6/12/2014 CADILA HEALTHCARE LTD LURASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28282 A II 5/28/2014 HARMAN FINOCHEM LTD CHOLINE FENOFIBRATE AS MANUFACTURED IN MAHARASHTRA, INDIA
28283 A II 5/5/2014 BASF PHARMACHEMIKALIEN GMBH CO KG (-)-EPHEDRINE SULFATE AS MANUFACTURED IN MINDEN, F. R. OF GERMANY
Page 856
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28284 A II 5/9/2014 ZHEJIANG JIUZHOU PHARMACEUTICAL CO
LTD
RUFINAMIDE AS MANUFACTURED IN ZHEJIANG, CHINA
28285 A II 5/29/2014 CADILA HEALTHCARE LTD DABIGATRAN ETEXILATE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28286 A III 5/13/2014 SABIC PETROCHEMICALS BV SABIC PP PCGR40L AS MANUFACTURED IN GELEEN, THE NETHERLANDS
28287 A II 6/13/2014 DIPHARMA FRANCIS SRL FEXOFENADINE HYDROCHLORIDE USP FORM A AS MANUFACTURED IN MERETO DI
TOMBA (UD), ITALY
28288 P *** PENDING FILING REVIEW ***
28289 A II 6/19/2014 ALKEM LABORATORIES LTD SODIUM OXYBATE (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
28290 A III 5/10/2014 CHEMIPACK INDIA PRIVATE LTD H.D.P.E. CANISTERS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28291 A III 5/13/2014 KUNSTSTOFFWERK KREMSMUNSTER GMBH PP28 CHILD RESISTANT CAPS T/E WITH VARIOUS LINERS AS MANUFACTURED IN
KREMSMNSTER, AUSTRIA
28292 A II 6/24/2014 ALP PHARM BEIJING CO LTD ABIRATERONE ACETATE (ESUB) AS MANUFACTURED IN INNO MONGOLIA, CHINA FOR
ALP PHARM BEIJING CO LTD
28293 A II 6/12/2014 LAURUS LABS PRIVATE LTD CABAZITAXEL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28294 P *** PENDING FILING REVIEW ***
28295 P *** PENDING FILING REVIEW ***
28296 A II 5/23/2014 UNIMARK REMEDIES LTD IMIPENEM CRUDE (INTERMEDIATE)(ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28297 A II 6/4/2014 HETERO DRUGS LTD BUPROPION HYDROCHLORIDE (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28298 A II 6/11/2014 LUPIN LTD GLYCEROL PHENYLBUTYRATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR
LUPIN LIMITED
28299 A II 5/28/2014 CTX LIFE SCIENCES PVT LTD SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28300 A II 5/24/2014 BIOPHORE INDIA PHARMACEUTICALS PVT
LTD
MELPHALAN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE
INDIA PHARMACEUTICALS PVT. LTD.
28301 A II 6/5/2014 SIGMAPHARM LABORATORIES LLC AMORPHOUS DOFETILIDE (ESUB) AS MANUFACTURED IN BENSALEM. PA
28302 A II 5/15/2014 ZHEJIANG KANGLE PHARMACEUTICAL CO
LTD
ACETAMINOPHEN DC90 FINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
28303 P *** PENDING FILING REVIEW ***
28304 A II 5/13/2014 QINHUANGDAO ZIZHU PHARMACEUTICAL
CO LTD
ESTRONE AS MANUFACTURED IN HEBEI PROVINCE, CHINA
28305 A V 5/16/2014 DAIKYO SEIKO LTD DAIKYO RUV PROCESS
28306 A II 5/16/2014 DIVIS LABORATORIES LTD PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28307 A III 5/14/2014 ARMOR SAS AXR 600R THERMAL TRANSFER RIBBON AS MANUFACTURED IN LA CHEVROLIERE,
FRANCE
28308 A II 6/17/2014 TOPCHEM PHARMACEUTICALS LTD TOLCAPONE (ESUB) AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND
28309 A II 5/22/2014 TOPHARMAN SHANDONG CO LTD TELMISARTAN (ESUB) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA
28310 P *** PENDING FILING REVIEW ***
28311 A III 5/6/2014 APTAR FRANCE SAS APTAR METHODS FOR CONTROLLING PACKAGING COMPONENTS AS MANUFACTURED IN
RADOLFZELL AND EIGELTINGEN, GERMANY; LE NEUBOURG, VERNEUIL, CHARLEVAL AND
LE VAUDREUIL, FRANCE FOR APTAR FRANCE S.A.S.
28312 A II 5/19/2014 PROCOS SPA GUANFACINE HYDROCHLORIDE AS MANUFACTURED IN CAMERI (NO), ITALY
28313 A III 4/26/2014 CINCORP INTERNATIONAL LTD HDPE BOTTLES/CONTAINERS AS MANUFACTURED IN UTTAR PRADESH, INDIA
28314 A II 6/10/2014 BRIGHTGENE BIOMEDICAL TECHNOLOGY
CO LTD
POSACONAZOLE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA FOR BRIGHTGENE BIO-
MEDICAL TECHNOLOGY CO., LTD
Page 857
4Q2012 2Q2014EXCEL
28315 P *** PENDING FILING REVIEW ***
28316 A II 6/25/2014 DR REDDYS LABORATORIES LTD PEMETREXED DITROMETHAMINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28317 A III 4/26/2014 CINCORP INTERNATIONAL LTD CLOSURES AND MEASURING CUPS AS MANUFACTURED IN UTTAR PRADESH, INDIA
28318 A III 5/9/2014 HUDSON COLOR CONCENTRATES WHITE HC80510LD AS MANUFACTURED IN LEOMINSTER, MA
28319 A II 5/19/2014 PHARMACEUTICAL WORKS POLPHARMA SA SILDENAFIL BASE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND
28320 P *** PENDING FILING REVIEW ***
28321 A II 6/3/2014 UNIMARK REMEDIES LTD CILASTATIN ACID (INTERMEDIATE) (ESUB) AS MANUFACATURED IN GUJARAT, INDIA
28322 P *** PENDING FILING REVIEW ***
28323 A II 6/5/2014 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
RIVAROXABAN (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
28324 A IV 6/25/2014 ASHLAND SPECIALITY INGREDIENTS GP BENECELPH DC HYPROMELLOSE (ESUB) AS MANUFACTURED IN READING, PA AND
DOEL-BEVEREN, BELGIUM FOR ASHLAND SPECIALTY INGREDIENTS GP
28325 A II 5/29/2014 BEIJING HUIKANG BOYUAN CHEMICAL TECH
CO LTD
SITAGLIPTIN PHOSPHATE MONOHYDRATE (ESUB) AS MANUFACTURED IN BEIJING, CHINA
28326 P *** PENDING FILING REVIEW ***
28327 A III 5/27/2014 RAVAGO MANUFACTURING AMERICAS CRYSTALADD HM-237 AS MANUFACTURED IN MANCHESTER, TN
28328 A IV 5/27/2014 FONA INTERNATIONAL INC 805.011 N-C BANANA FLAVOR, ART AS MANUFACTURED IN GENEVA, IL
28329 A II 5/21/2014 GALAXY SURFACTANTS LTD OCTOCRYLENE AS MANUFACTURED IN MAHARASHTRA, INDIA
28330 A III 5/15/2014 SICHUAN HUILI INDUSTRY CO LTD PCTFE/PVC COMPOSITE SHEET FOR PACKAGING OF SOLID DOSAGE FORMS AS
MANUFACTURED IN SICHUAN, P.R. CHINA
28331 A V 5/23/2014 HAUPT PHARMA WOLFRATSHAUSEN GMBH STERILE DEPARTMENT 2, ASEPTIC PROCESS VALIDATION OF CYTOTOXIC PRODUCTS
28332 A III 5/14/2014 AMPACET CORP 1800268-NQ AMBER PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
28333 A II 6/13/2014 CIPLA LTD IMATINIB MESYLATE (BETA FORM) (ESUB) AS MANUFACTURED IN BANGALORE, INDIA
28334 A II 6/13/2014 DR REDDYS LABORATORIES LTD ROSUVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28335 A II 5/24/2014 HIKAL LTD GABEPENTIN (A01804) AS MANUFACTURED IN BANGALORE, INDIA
28336 A II 5/23/2014 MEGAFINE PHARMA P LTD DAR-IV (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN
MAHARASHTRA, INDIA
28337 A II 5/30/2014 IRVINE SCIENTIFIC SALES CO BALANCD MDCK - LIQUID AS MANUFACTURED IN SANTA ANA, CA
28338 A II 5/30/2014 IRVINE SCIENTIFIC SALES CO BALANCD MDCK - POWDER AS MANUFACTURED IN SANTA ANA, CA
28339 A II 6/17/2014 CHIROGATE INTERNATIONAL INC UNOPROSTONE ISOPROPYL (ESUB) AS MANUFACTURED IN TAIWAN, CHINA
28340 P *** PENDING FILING REVIEW ***
28341 A II 6/11/2014 ZHEJIANG HISUN PHARMACEUTICAL CO LTD ARIPIPRAZOLE USP (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
28342 A II 6/19/2014 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DASATINIB (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
28343 P *** PENDING FILING REVIEW ***
28344 P *** PENDING FILING REVIEW ***
28345 P *** PENDING FILING REVIEW ***
28346 A II 5/29/2014 ZHEJIANG TIANYU PHARMACEUTICAL CO
LTD
LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG, CHINA
Page 858
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28347 A IV 5/30/2014 DAVID MICHAEL AND CO INC NATURAL AND ARTIFICIAL GRAPE FLAVOR #27069 AS MANUFACTURED IN PHILADELPHIA,
PA
28348 A II 6/3/2014 3M PURIFICATION INC EMPHAZE AEX HYBRID PURIFIER CAPSULES AS MANUFACTURED IN ST. PAUL, MN;
COLUMBIA, MO AND MERIDEN, CT
28349 A II 6/27/2014 SHILPA MEDICARE LTD IMATINIB MESYLATE (IMN) (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA
28350 A II 5/30/2014 LIVZON GROUP FUZHOU FUXING
PHARMACEUTICAL CO LTD
COLISTIMETHATE SODIUM AS MANUFACTURED IN FUJIAN PROVINCE, P.R. CHINA
28351 A II 6/2/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD AMLODIPINE BESYLATE (PROCESS II) AS MANUFACTURED IN GUAYAMA, PUERTO RICO
FOR TEVA PHARMACEUTICAL INDUSTRIES LTD.
28352 P *** PENDING FILING REVIEW ***
28353 P *** PENDING FILING REVIEW ***
28354 P *** PENDING FILING REVIEW ***
28355 A II 6/20/2014 XELLIA PHARMACEUTICALS APS BACITRACIN ZINC, STERILE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA AND
CORONA, CA FOR XELLIA PHARMACEUTICALS APS
28356 A II 6/16/2014 UNIMARK REMEDIES LTD IMIPENEM USP (STERILE) AS MANUFACTURED IN GUJARAT, INDIA
28357 A II 6/5/2014 HETERO DRUGS LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28358 A II 6/11/2014 ALCHYMARS ICM SM PRIVATE LTD BISMUTH SUBCITRATE POTASSIUM (ESUB) AS MANUFACTURED IN TAMIL NADU, INDIA
28359 P *** PENDING FILING REVIEW ***
28360 A II 6/30/2014 CIPLA LTD VALGANCICLOVIR HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA,
INDIA
28361 A II 6/6/2014 YABAO PHARMACEUTICAL GROUP CO LTD PROMESTRIENE AS MANUFACTURED IN SHANXI, CHINA
28362 A III 6/4/2014 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN PRE-COLOR COMPOUNDS B25400-P BLUE AND B25401-P BLUE
AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
28363 A III 5/29/2014 SHREE GAURAV POLYMERS PVT LTD SILICON RUBBER TUBING PEROXIDE/PLATINUM TREATED AS MANUFACTURED IN
GUJARAT, INDIA
28364 A III 5/29/2014 SHREE GAURAV POLYMERS PVT LTD SILICONE RUBBER BRAIDED TUBING AS MANUFACTURED IN GUJARAT, INDIA
28365 A II 6/12/2014 UNIMARK REMEDIES LTD CILASTATIN SODIUM USP (STERILE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28366 A IV 5/30/2014 MASTERTASTE INC DBA KERRY INC 30626205 NAT FL MOD (MASKING) FMT PWD AS MANUFACTURED IN CLARK, NJ
28367 P *** PENDING FILING REVIEW ***
28368 P *** PENDING FILING REVIEW ***
28369 P *** PENDING FILING REVIEW ***
28370 A IV 6/9/2014 FONA INTERNATIONAL INC 889.0066U PEACH FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL
28371 A II 6/16/2014 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
TOPIRAMATE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
28372 A II 6/19/2014 ZHEJIANG HUAHAI PHARMACEUTICAL CO
LTD
FINGOLIMOD HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA
28373 P *** PENDING FILING REVIEW ***
28374 A III 6/4/2014 NOLATO JAYCARE LTD CR SPRAY COLLAR AND CAP AS MANUFACTURED IN NEWCASTLE UPON TYNE, ENGLAND
28375 A II 6/9/2014 PCAS ESOMEPRAZOLE SODIUM AS MANUFACTURED IN TURKU, FINLAND
28376 A II 6/6/2014 SRIKEM LABORATORIES PVT LTD HYDROXYZINE HYDROCHLORIDE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA
28377 A III 6/5/2014 AMPACET CORP 1700634-N TEAL PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
CARTERSVILLE, GA AND HEATH, OH
28378 A III 6/11/2014 PFP TERMOPOLIMEROS SL PILD-CRC AL CONTAINER AS MANUFACTURED IN FIGARO (BARCELONA) , SPAIN
Page 859
4Q2012 2Q2014EXCEL
28379 P *** PENDING FILING REVIEW ***
28380 A II 5/20/2014 WATERSTONE PHARMACEUTICALS HUBEI
CO LTD
LANSOPRAZOLE AS MANUFACTURED IN HUBEI, CHINA
28381 A II 6/18/2014 UNIMARK REMEDIES LTD STERILE MIXTURE FOR IMIPENEM, CILASTATIN SODIUM AND SODIUM BICARBONATE
(DRUG PRODUCT INTERMEDIATE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28382 A II 6/19/2014 UNIMARK REMEDIES LTD STERILE MIXTURE FOR MEROPENEM AND SODIUM CARBONATE (DRUG PRODUCT
INTERMEDIATE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28383 A II 6/13/2014 HETERO LABS LTD ABIRATERONE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28384 A II 6/13/2014 JILIN ASYMCHEM LABORATORIES CO LTD PITAVASTATIN CALCIUM AS MANUFACTURED IN JILIN, CHINA
28385 A II 6/3/2014 CAMBREX PROFARMACO MILANO SRL EPINEPHRINE BITARTRATE AS MANUFACTURED IN MILAN, ITALY
28386 A II 6/3/2014 WUHAN ZY PHARMACEUTICAL CO LTD POSACONAZOLE AS MANUFACTURED IN HUBEI PROVINCE, CHINA
28387 A II 6/24/2014 INTAS PHARMACEUTICALS LTD FINGOLIMOD HYDROCHLORIDE (FORM 1) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA
28388 P *** PENDING FILING REVIEW ***
28389 A II 6/16/2014 DAIICHI FINE CHEMICAL CO LTD OLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA,
JAPAN
28390 A II 6/30/2014 CADILA HEALTHCARE LTD DULOXETINE HYDROCHLORIDE USP (PROCESS-II) (ESUB) AS MANUFACTURED IN
GUJARAT, INDIA
28391 A II 6/16/2014 SEQUENT SCIENTIFIC LTD ERTAPENEM SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR SEQUENT
SCIENTIFIC LTD.
28392 A II 6/30/2014 DR REDDYS LABORATORIES LTD MIRABEGRON [PRODUCT CODE: AEB] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,
INDIA
28393 A III 6/15/2014 ADHESIVES RESEARCH INC SR-26 (A-4493) AS MANUFACTURED IN GLEN ROCK, PA
28394 A III 6/15/2014 ADHESIVES RESEARCH INC MA-111 (A-5181-99) AS MANUFACTURED IN GLEN ROCK, PA
28395 P *** PENDING FILING REVIEW ***
28396 A II 6/30/2014 PIRAMAL ENTERPRISES LTD PREGABALIN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28397 P *** PENDING FILING REVIEW ***
28398 A II 6/17/2014 SHODHANA LABORATORIES LTD DULOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28399 A IV 6/18/2014 FONA INTERNATIONAL INC 915.1071U STRAWBERRY FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL
28400 P *** PENDING FILING REVIEW ***
28401 P *** PENDING FILING REVIEW ***
28402 A IV 6/18/2014 SPI PHARMA INC PHARMABURST 530 AS MANUFACTURED IN GRAND HAVEN, MI
28403 A II 6/10/2014 SHANDONG XINHUA PHARMACEUTICAL CO
LTD
IBUPROFEN SODIUM AS MANUFACTURED IN SHANDONG, P.R. CHINA
28404 A II 6/26/2014 BEIJING HUIKANG BOYUAN CHEMICAL TECH
CO LTD
LINAGLIPTIN (ESUB) AS MANUFACTURED IN BEIJING, CHINA
28405 P *** PENDING FILING REVIEW ***
28406 P *** PENDING FILING REVIEW ***
28407 A IV 6/12/2014 JIAOZUO ZHONGWEI SPECIAL PRODUCTS
PHARMACEUTICAL CO LTD
POVIDONE AS MANUFACTURED IN HENAN PROVINCE, CHINA
28408 A IV 6/16/2014 JIAOZUO ZHONGWEI SPECIAL PRODUCTS
PHARMACEUTICAL CO LTD
CROSPOVIDONE AS MANUFACTURED IN HENAN PROVINCE CHINA
28409 A II 6/19/2014 VIWIT PHARMACEUTICAL CO LTD LULICONAZOLE AS MANUFACTURED IN SHANGHAI, CHINA
28410 P *** PENDING FILING REVIEW ***
28411 P *** PENDING FILING REVIEW ***
Page 860
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28412 P *** PENDING FILING REVIEW ***
28413 P *** PENDING FILING REVIEW ***
28414 P *** PENDING FILING REVIEW ***
28415 A II 6/19/2014 UNION QUIMICO FARMACEUTICA SA MIVACURIUM CHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN
28416 A II 6/20/2014 ASYMCHEM LIFE SCIENCE TIANJIN CO LTD SAPROPTERIN AS MANUFACTURED IN TIANJIN, CHINA
28417 P *** PENDING FILING REVIEW ***
28418 P *** PENDING FILING REVIEW ***
28419 P *** PENDING FILING REVIEW ***
28420 A II 6/25/2014 OPTIMUS DRUGS PRIVATE LTD (1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON
INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
28421 A II 6/21/2014 HIKAL LTD BUPROPION HYDROCHLORIDE USP [PROCESS-2] AS MANUFACTURED IN KARNATAKA,
INDIA
28422 A II 6/13/2014 SKUNY BIOSCIENCE CO LTD ICOSAPENT ETHYL AS MANUFACTURED IN SICHUAN, P. R. CHINA
28423 P *** PENDING FILING REVIEW ***
28424 P *** PENDING FILING REVIEW ***
28425 A II 6/16/2014 SKUNY BIOSCIENCE CO LTD DOCOSAHEXAENOIC ACID ETHYL ESTER AS MANUFACTURED IN SICHUAN, P. R. CHINA
28426 A IV 6/16/2014 HENKEL CORP GELVA GMS 737 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY,
NC
28427 A V 6/26/2014 DOW CORNING CORP DOW CORNING SILAC HYBRID PRESSURE SENSITIVE ADHESIVES
28428 P *** PENDING FILING REVIEW ***
28429 A III 6/20/2014 REXAM PHARMA PACKAGING INDIA PVT. LTD HDPE PLASTIC CONTAINER AS MANUFACTURED IN BANGALORE, INDIA
28430 A III 6/30/2014 TERUMO CORP I-COATING STOPPERS AS MANUFACTURED IN SHIZUOKA, JAPAN
28431 A II 6/30/2014 SMS PHARMACEUTICALS LTD LEVETIRACETAM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
Page 861