FdaApplication
ANDA 091675
Identifiers
- fda_app_no: ANDA091675
Properties
| Property | Value |
|---|---|
| applicant_name | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| application_type | ANDA |
| approval_date | 2012-06-28 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL |
1 product