FdaApplication
ANDA 091687
Identifiers
- fda_app_no: ANDA091687
Properties
| Property | Value |
|---|---|
| applicant_name | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| application_type | ANDA |
| approval_date | 2012-06-28 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML | SYRUP;ORAL |
| PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 15MG/5ML | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL |
2 products