Application 204964
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 100MG | No | No |
| 002 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 200MG | No | No |
| 003 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68180-802 | RUFINAMIDE | rufinamide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-802 | RUFINAMIDE | rufinamide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-803 | RUFINAMIDE | rufinamide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-803 | RUFINAMIDE | rufinamide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-804 | RUFINAMIDE | rufinamide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-804 | RUFINAMIDE | rufinamide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72041 | ORIG | 2022-09-08 |