Skip to contentApplication 219293
- Type
- NDA
- Sponsor
- AZURITY
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DANZITEN | NILOTINIB TARTRATE | TABLET;ORAL | EQ 71MG BASE | Yes | Yes |
| 002 | DANZITEN | NILOTINIB TARTRATE | TABLET;ORAL | EQ 95MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85722 | SUPPL | 2026-04-21 |
| 85691 | SUPPL | 2026-04-21 |
| 85714 | SUPPL | 2026-04-20 |
| 84196 | SUPPL | 2025-11-18 |
| 84185 | SUPPL | 2025-11-18 |
| 83680 | ORIG | 2025-10-07 |
| 80188 | ORIG | 2024-11-08 |
| 80184 | ORIG | 2024-11-08 |