Email Worksheet

The application form has six parts: 1) General

Information, 2) Establishment Information, 3) Product SUBJECT:
Information, 4) Supporting Information, 5) Sources and
Clients, and 6) Applicant Information. In the worksheet
'Form' (with the red tab) you will see a dashboard
where the different parts are identified. If the part is
appropriately filled up, a green 'PROCEED' will be
indicated.Required fields will appear sequentially.To BODY:
minimize errors and confusion, it is recommended that
a blank form be used for every application. If the form
is appropriately filled up, the composed body text (in
the green box) will appear.
Be careful to paste the body text completely as text
(not as an image or as an attachment). DON'T attach
any file to the email request. Printing Instructions
(Please print the following parts of the worksheet 'Form'
For Drug Registration (excluding amendment
For Non-Drug Registration (excluding amendment
For Licensing (exclusing amendment
For All

Application Process Overview

 IMPORTANT

READ THIS PAGE CAREFULLY.

Provide information only
when asked for.

of the worksheet 'Form' if applicable)

on (excluding amendments and compliances): pages 1 and 4.
on (excluding amendments and compliances): pages 1 and 3.
ng (exclusing amendments and compliances): pages 1 and 2.
For All Other Applications: page 1 only.
 APPLICATION FORM 5 SOURCES

Document Tracking Number APPLICATION FORM STATUS

GENERAL INFORMATION:
ESTABLISHMENT INFORMATION:
Description (Optional): PRODUCT INFORMATION:
SUPPORTING INFORMATION:
1 GENERAL INFORMATION SOURCES & CLIENTS:
APPLICANT INFORMATION:
1.1 Product Center:

This form was last edited on 13 October 2016, 10:28 AM.

 Off-white to beige, semi
CLOPIDOGREL (as BISULFATE) coated tablet with score
plain on the other side
 Off-white to beige, semi
CLOPIDOGREL (as BISULFATE) coated tablet with score
plain on the other side
CLOPIDOGREL (AS BISULFATE) NINBO BEITON
2) Active Pharmaceutical Ingredient; 2) API Manufac
3) Active Pharmaceutical Ingredient; 3) API Manufac
4) Active Pharmaceutical Ingredient; 4) API Manufac
5) Active Pharmaceutical Ingredient; 5) API Manufac
6) Active Pharmaceutical Ingredient; 6) API Manufac
7) Active Pharmaceutical Ingredient; 7) API Manufac
8) Active Pharmaceutical Ingredient; 8) API Manufac
9) Active Pharmaceutical Ingredient; 9) API Manufac
10) Active Pharmaceutical Ingredient; 10) API Manufa
11) Active Pharmaceutical Ingredient; 11) API Manufa
12) Active Pharmaceutical Ingredient; 12) API Manufa
OURCES & CLIENTS
 Provide in this space a description of the
eige, semi biconvex film- product in terms of rheology, thermal, Use this space to explain how the lot
and geometry properties among others, code used on the product label is
with score on one side and as applicable; Indicate if appropriate
her side microbiological cultures present in the correctly interpreted
product
Provide in this space a description of the
product in terms of rheology, thermal, Use this space to explain how the lot
and geometry properties among others, code used on the product label is
as applicable; Indicate if appropriate
microbiological cultures present in the correctly interpreted
product
O BEITONG IMP. & EXP. CO. LTD., INDIA
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
I Manufacturer, Address Address Address;
KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
2) API Supplier, Address Address Address;
3) API Supplier, Address Address Address;
4) API Supplier, Address Address Address;
5) API Supplier, Address Address Address;
6) API Supplier, Address Address Address;
7) API Supplier, Address Address Address;
8) API Supplier, Address Address Address;
9) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;
 Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM
GENERAL INFORMATION: 0 0 0 0 0 0 0 SOURCES & CLIENTS: 0 1
ESTABLISHMENT INFORMATION: 0 0 0 0 1 Document Tracking Number
PRODUCT INFORMATION: 0 0 0 0 1 0 0
SUPPORTING INFORMATION: 0 1 0 0 0 0 0
APPLICANT INFORMATION: 0 0 0 0 Description (Optional):
PAYMENT INFORMATION: 0 0 0
GENERAL INFORMATION

1.1 Product Center: 0 1

0
1
0 1
1
1

0 1
30-Dec-1899 1

1
1
0
30-Dec-1899 1
0
0 1
0 0 1
0 0 0 1

0 1
0
1 1
Drug 1 0 HUHS
0 0 Food 0 Device

0
0 0

0 0
0
1 0
0
1 1 0
Type of Amendment: Other Amendments 0 0
Source: Add/ Delete FAL 0 License to Operate FAL 0 0

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 Department of Health
Food and Drug Administration
Source: Change of FAL 0 APPLICATION
Reclassification 0 FORM
FAL 0
Change of Importer/FAL 0 0 Change of Distributor FAL 0 0 0
TRU 1 Finished Product FAL 0 Php -
FAL 0 Raw Material FAL 0
1 Free Sale, CertificateFAL 0 1
Pharmaceutical Produ FAL 0
Export Certificate FAL 0 0
Additional ProductioFAL 0 0 1
1

1
1
1
1
1
1 0 1
1
1 0 1
1
1 0 1

1
1
1

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 Department of Health
Food and Drug Administration
APPLICATION FORM 1
1
1 0 1
1
1 0 1
1
1 0 1

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM 1
0 1
1 1
1 1
1 1 1 1

1 1

1 1

1 1

1 1

1 1

1 1

1 1

1 1

1 1

1
1 1
1 1
1 1
1 1
1 1
1 1 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1

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 Department of Health
Food and Drug Administration
0 APPLICATION
1 FORM 0 1
01 1 01 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0

1 1

1 1

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 Department of Health
Food and Drug Administration
APPLICATION FORM
1 1
1 1
1 1
0 1 0 1
01 1 01 1

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

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LTO APP Na Com
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 DES
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 APPLOTHER REQUEST PAYMENT DETAILS
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0 0 0 ### 0 ### ### ### ### ### ### ### ### ### ### ### ### ###