Application 208303
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 500MCG | No | No |
| 002 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 250MCG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68382-969 | Roflumilast | Roflumilast | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1674 | Roflumilast | Roflumilast | Cadila Healthcare Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72954 | ORIG | 2022-12-20 |