Home Applications 210656 Application 210656
Type NDA
Sponsor PFIZER INC Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210656-001 DAURISMO GLASDEGIB MALEATE EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 N210656-002 DAURISMO GLASDEGIB MALEATE EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210656-001 8431597 2028-06-29 Drug product 2018-12-18 N210656-001 8148401 2032-11-21 Drug substance, Drug product 2018-12-18 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 N210656-002 8148401 2032-11-21 Drug substance, Drug product 2018-12-18 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 N210656-002 11891372 2036-04-13 U-3254 2024-03-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210656-001 DAURISMO EQ 25MG BASE TABLET / ORAL RLD 2018-11-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210656-002 DAURISMO EQ 100MG BASE TABLET / ORAL RLD, RS 2018-11-21 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 9 · 336 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 8148401 2029-04-14 Drug substance, Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 8148401 2029-04-14 Drug substance, Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 8431597 2028-06-29 Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 11168066 2036-04-13 U-3254 2021-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-001 11891372 2036-04-13 U-3254 2024-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 8431597 2028-06-29 Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 8148401 2031-01-30 Drug substance, Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 10414748 2036-04-13 Drug substance, Drug product 2019-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 11168066 2036-04-13 U-3254 2021-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210656-002 11891372 2036-04-13 U-3254 2024-03-06 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table 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 table 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