Application 209284
- Type
- ANDA
- Sponsor
- DR REDDYS
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 |
|---|---|---|---|---|---|
| 43598-394 | Tetrabenazine | Tetrabenazine | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-394 | Tetrabenazine | Tetrabenazine | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-394 | Tetrabenazine | Tetrabenazine | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-395 | Tetrabenazine | Tetrabenazine | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-395 | Tetrabenazine | Tetrabenazine | Dr. Reddys Laboratories Inc | ANDA | Current |
| 43598-395 | Tetrabenazine | Tetrabenazine | Dr. Reddys Laboratories Inc | ANDA | Current |