Application 210656
- Type
- NDA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAURISMO | GLASDEGIB MALEATE | TABLET;ORAL | EQ 25MG BASE | Yes | No |
| 002 | DAURISMO | GLASDEGIB MALEATE | TABLET;ORAL | EQ 100MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0298 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0298 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0298 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0298 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0298 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1531 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1531 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1531 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1531 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1531 | Daurismo | glasdegib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73896 | SUPPL | 2023-03-28 |
| 73895 | SUPPL | 2023-03-28 |
| 73887 | SUPPL | 2023-03-28 |
| 62215 | SUPPL | 2020-03-20 |
| 62214 | SUPPL | 2020-03-20 |
| 62212 | SUPPL | 2020-03-20 |
| 62211 | SUPPL | 2020-03-20 |
| 62210 | SUPPL | 2020-03-20 |
| 62209 | SUPPL | 2020-03-20 |
| 56753 | ORIG | 2018-12-17 |
| 56700 | ORIG | 2018-12-10 |
| 56533 | ORIG | 2018-11-21 |