Application 091687
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 15MG/5ML;6.25MG/5ML | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | TABLET, CHEWABLE, TABLET, CAPSULE; ORAL | 15MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27808-057 | Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Tris Pharma Inc | ANDA | Current |
| 27808-057 | Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Tris Pharma Inc | ANDA | Current |