Application 212308
- Type
- ANDA
- Sponsor
- ZYDUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEFLUNOMIDE | LEFLUNOMIDE | TABLET;ORAL | 10MG | No | No |
| 002 | LEFLUNOMIDE | LEFLUNOMIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70710-1157 | leflunomide | leflunomide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1157 | leflunomide | leflunomide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1158 | leflunomide | leflunomide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1158 | leflunomide | leflunomide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1491 | leflunomide | leflunomide | Cadila Healthcare Limited | ANDA | Current |
| 70771-1492 | leflunomide | leflunomide | Cadila Healthcare Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58423 | ORIG | 2019-04-26 |