Skip to contentApplication 218922
- Type
- NDA
- Sponsor
- CIPLA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | CAPSULE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | CAPSULE;ORAL | EQ 150MG BASE | Yes | No |
| 003 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | CAPSULE;ORAL | EQ 200MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85098 | ORIG | 2026-02-20 |
| 82813 | SUPPL | 2025-07-11 |
| 82812 | SUPPL | 2025-07-11 |
| 82787 | SUPPL | 2025-07-11 |
| 81305 | ORIG | 2025-02-21 |
| 81291 | ORIG | 2025-02-20 |