Application 216993
- Type
- NDA
- Sponsor
- DAIICHI SANKYO INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 17.7MG BASE | Yes | No |
| 002 | VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 26.5MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85791 | SUPPL | 2026-05-01 |
| 85687 | SUPPL | 2026-04-15 |
| 85684 | SUPPL | 2026-04-15 |
| 78925 | SUPPL | 2024-06-27 |
| 78900 | SUPPL | 2024-06-26 |
| 76272 | ORIG | 2023-11-03 |
| 75066 | ORIG | 2023-08-14 |
| 74845 | ORIG | 2023-07-21 |
| 74820 | ORIG | 2023-07-20 |
| 74819 | ORIG | 2023-07-20 |