Skip to contentApplication 211349
- Type
- NDA
- Sponsor
- ASTELLAS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XOSPATA | GILTERITINIB FUMARATE | TABLET;ORAL | EQ 40MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0469-1425 | Xospata | gilteritinib | Astellas Pharma US, Inc. | NDA | Current |
| 0469-1425 | Xospata | gilteritinib | Astellas Pharma US, Inc. | NDA | Current |
| 0469-1425 | Xospata | gilteritinib | Astellas Pharma US, Inc. | NDA | Current |
| 0469-1425 | Xospata | gilteritinib | Astellas Pharma US, Inc. | NDA | Current |
| 0469-1425 | Xospata | gilteritinib | Astellas Pharma US, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69874 | SUPPL | 2022-01-13 |
| 69873 | SUPPL | 2022-01-13 |
| 69868 | SUPPL | 2022-01-13 |
| 64574 | SUPPL | 2020-09-14 |
| 58934 | SUPPL | 2019-06-04 |
| 58880 | SUPPL | 2019-05-30 |
| 58879 | SUPPL | 2019-05-30 |
| 56985 | ORIG | 2018-12-21 |
| 56610 | ORIG | 2018-11-30 |
| 56581 | ORIG | 2018-11-28 |