Application 209739
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TETRABENAZINE | TETRABENAZINE | TABLET;ORAL | 12.5MG | No | No |
| 002 | TETRABENAZINE | TETRABENAZINE | TABLET;ORAL | 25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0468 | Tetrabenazine | Tetrabenazine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0468 | Tetrabenazine | Tetrabenazine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0469 | Tetrabenazine | Tetrabenazine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0469 | Tetrabenazine | Tetrabenazine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |