Application 211782
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | APREMILAST | APREMILAST | TABLET;ORAL | 10MG | No | No |
| 002 | APREMILAST | APREMILAST | TABLET;ORAL | 20MG | No | No |
| 003 | APREMILAST | APREMILAST | TABLET;ORAL | 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60219-1410 | APREMILAST | APREMILAST | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1744 | APREMILAST | APREMILAST | Amneal Pharmaceuticals NY LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59610 | ORIG | 2019-08-07 |