Application 212490
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 250MCG | No | No |
| 002 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 500MCG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68380 | ORIG | 2021-08-16 |