FdaApplication
ANDA 091054
Identifiers
- fda_app_no: ANDA091054
Properties
| Property | Value |
|---|---|
| applicant_name | AUROBINDO PHARMA USA INC |
| application_type | ANDA |
| approval_date | 2011-08-30 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL |
3 products