SubmissionClassCodeID SubmissionClassCode SubmissionClassCodeDescription

1 BIOEQUIV Bioequivalence
2 EFFICACY Efficacy
3 LABELING Labeling
4 MANUF (CMC) Manufacturing (CMC)
5 N/A Not Applicable
6 S Supplement
7 TYPE 1 Type 1 - New Molecular Entity
8 TYPE 1/4 Type 1 - New Molecular Entity and Type 4 - New Combinati
on
9 TYPE 2 Type 2 - New Active Ingredient
10 TYPE 2/3 Type 2 - New Active Ingredient and Type 3 - New Dosage F
orm
11 TYPE 2/4 Type 2 New Active Ingredient and Type 4 New Combination
12 TYPE 3 Type 3 - New Dosage Form
13 TYPE 3/4 Type 3 - New Dosage Form and Type 4 - New Combination
14 TYPE 4 Type 4 - New Combination
15 TYPE 5 Type 5 - New Formulation or New Manufacturer
16 TYPE 6 Type 6 - New Indication (no longer used)
17 TYPE 7 Type 7 - Drug Already Marketed without Approved NDA
18 TYPE 8 Type 8 - Partial Rx to OTC Switch
19 UNKNOWN
20 Unspecified
21 REMS REMS
22 TYPE 10 Type 10 - New Indication Submitted as Distinct NDA - Not Consoli
dated
23 MEDGAS Medical Gas
24 TYPE 9 Type 9 - New Indication Submitted as Distinct NDA, Consolidated
with Original NDA after Approval
25 TYPE 9- BLA Type 9 - New indication submitted as distinct BLA, conso
lidated