Application 204993
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 200MG | No | No |
| 002 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-598 | Rufinamide | Rufinamide | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-599 | Rufinamide | Rufinamide | Camber Pharmaceuticals, Inc. | ANDA | Current |