Application 217431
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | IVACAFTOR | IVACAFTOR | GRANULE;ORAL | 25MG | No | No |
| 003 | IVACAFTOR | IVACAFTOR | GRANULE;ORAL | 50MG | No | No |
| 004 | IVACAFTOR | IVACAFTOR | GRANULE;ORAL | 75MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81314 | ORIG | 2025-02-24 |