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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210656-001	DAURISMO	EQ 25MG BASE	TABLET / ORAL	RLD	2018-11-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210656-002	DAURISMO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-11-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210656-001	DAURISMO	EQ 25MG BASE	TABLET / ORAL	RLD	2018-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210656-002	DAURISMO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210656-001	DAURISMO	EQ 25MG BASE	TABLET / ORAL	RLD	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210656-002	DAURISMO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-11-21	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 3 of 10 · 366 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-001	8431597	2028-06-29		Drug product	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-001	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-001	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-001	11168066	2036-04-13	U-3254		2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-001	11891372	2036-04-13	U-3254		2024-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-002	8431597	2028-06-29		Drug product	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-002	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-002	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-002	11168066	2036-04-13	U-3254		2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-002	11891372	2036-04-13	U-3254		2024-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-001	8431597	2028-06-29		Drug product	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-001	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-001	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-001	11168066	2036-04-13	U-3254		2021-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-001	11891372	2036-04-13	U-3254		2024-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-002	8431597	2028-06-29		Drug product	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-002	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-002	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-002	11168066	2036-04-13	U-3254		2021-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-002	11891372	2036-04-13	U-3254		2024-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-001	8431597	2028-06-29		Drug product	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-001	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-001	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-001	11168066	2036-04-13	U-3254		2021-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-001	11891372	2036-04-13	U-3254		2024-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-002	8431597	2028-06-29		Drug product	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-002	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-002	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-002	11168066	2036-04-13	U-3254		2021-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-002	11891372	2036-04-13	U-3254		2024-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-001	8431597	2028-06-29		Drug product	2018-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-001	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-001	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-001	11168066	2036-04-13	U-3254		2021-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-001	11891372	2036-04-13	U-3254		2024-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-002	8431597	2028-06-29		Drug product	2018-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-002	8148401	2031-01-30		Drug substance, Drug product	2018-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-002	10414748	2036-04-13		Drug substance, Drug product	2019-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-002	11168066	2036-04-13	U-3254		2021-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-002	11891372	2036-04-13	U-3254		2024-03-06	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210656-001	ODE-224	2025-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210656-002	ODE-224	2025-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210656-001	ODE-224	2025-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210656-002	ODE-224	2025-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210656-001	ODE-224	2025-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210656-002	ODE-224	2025-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210656-001	ODE-224	2025-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210656-002	ODE-224	2025-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-001	ODE-224	2025-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210656-002	ODE-224	2025-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-001	ODE-224	2025-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210656-002	ODE-224	2025-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-001	ODE-224	2025-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210656-002	ODE-224	2025-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-001	ODE-224	2025-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210656-002	ODE-224	2025-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210656-001	ODE-224	2025-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210656-002	ODE-224	2025-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210656-001	ODE-224	2025-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210656-002	ODE-224	2025-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210656-001	ODE-224	2025-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210656-002	ODE-224	2025-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210656-001	ODE-224	2025-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210656-002	ODE-224	2025-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210656-001	ODE-224	2025-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210656-002	ODE-224	2025-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210656-001	NCE	2023-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210656-001	ODE-224	2025-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210656-002	NCE	2023-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210656-002	ODE-224	2025-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210656-001	NCE	2023-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210656-001	ODE-224	2025-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210656-002	NCE	2023-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210656-002	ODE-224	2025-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210656-001	NCE	2023-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210656-001	ODE-224	2025-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210656-002	NCE	2023-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210656-002	ODE-224	2025-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210656-001	NCE	2023-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210656-001	ODE-224	2025-11-21	`74a2ff9319b5…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daurismo	GLASDEGIB	Pfizer Laboratories Div Pfizer Inc	204a6f7e-c9a4-472b-abd2-9527bda64d17	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210656 application number: NDA210656 ndc (product): 0069-0298 ndc (product): 0069-1531

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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