Application 218264
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
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 |