Application 209651
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 002 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | No | No |
| 003 | NILOTINIB HYDROCHLORIDE DIHYDRATE | NILOTINIB HYDROCHLORIDE DIHYDRATE | CAPSULE | 150MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81184 | ORIG | 2025-02-10 |