FdaApplication
ANDA 040428
Identifiers
- fda_app_no: ANDA040428
Properties
| Property | Value |
|---|---|
| applicant_name | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| application_type | ANDA |
| approval_date | 2002-02-05 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL |
2 products