FdaApplication
ANDA 040791
Identifiers
- fda_app_no: ANDA040791
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2008-02-12 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL |
3 products