Application 211863
- Type
- ANDA
- Sponsor
- LUPIN LTD
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 |
|---|---|---|---|---|---|
| 70748-129 | Leflunomide | Leflunomide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70748-129 | Leflunomide | Leflunomide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70748-130 | Leflunomide | Leflunomide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70748-130 | Leflunomide | Leflunomide | Lupin Pharmaceuticals, Inc. | ANDA | Current |