Application 040882
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-678 | Promethazine Hydrochloride | Promethazine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-678 | Promethazine Hydrochloride | Promethazine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-678 | Promethazine Hydrochloride | Promethazine | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |
| 65162-678 | Promethazine Hydrochloride | Promethazine | Amneal Pharmaceuticals LLC | ANDA | Current |