FdaApplication
ANDA 091528
Identifiers
- fda_app_no: ANDA091528
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2011-04-20 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG | TABLET;ORAL |
1 product