Application 213316
- Type
- ANDA
- Sponsor
- PIRAMAL HLTHCARE UK
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70436-101 | tetrabenazine | tetrabenazine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-101 | tetrabenazine | tetrabenazine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-102 | tetrabenazine | tetrabenazine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-102 | tetrabenazine | tetrabenazine | Slate Run Pharmaceuticals, LLC | ANDA | Current |