Application 211288

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIZIMPRO	DACOMITINIB	TABLET;ORAL	15MG	Yes	No
002	VIZIMPRO	DACOMITINIB	TABLET;ORAL	30MG	Yes	No
003	VIZIMPRO	DACOMITINIB	TABLET;ORAL	45MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211288-001	VIZIMPRO	DACOMITINIB	15MG	TABLET / ORAL	RLD	2018-09-27
N211288-002	VIZIMPRO	DACOMITINIB	30MG	TABLET / ORAL	RLD	2018-09-27
N211288-003	VIZIMPRO	DACOMITINIB	45MG	TABLET / ORAL	RLD, RS	2018-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211288-001	10596162	2026-02-02	U-3338		2022-04-13
N211288-001	10603314	2026-02-02	U-3337		2022-04-13
N211288-001	7772243	2032-09-27		Drug substance, Drug product	2018-10-25
N211288-002	10596162	2026-02-02	U-3338		2022-04-13
N211288-002	10603314	2026-02-02	U-3337		2022-04-13
N211288-002	7772243	2032-09-27		Drug substance, Drug product	2018-10-25
N211288-003	10596162	2026-02-02	U-3338		2022-04-13
N211288-003	10603314	2026-02-02	U-3337		2022-04-13
N211288-003	7772243	2032-09-27		Drug substance, Drug product	2018-10-25

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211288-002	VIZIMPRO	30MG	TABLET / ORAL	RLD	2018-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211288-003	VIZIMPRO	45MG	TABLET / ORAL	RLD, RS	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211288-001	VIZIMPRO	15MG	TABLET / ORAL	RLD	2018-09-27	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 414 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	N211288-001	10596162	2026-02-02	U-3338		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-001	10603314	2026-02-02	U-3337		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-001	7772243	2032-09-27		Drug substance, Drug product	2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-002	10596162	2026-02-02	U-3338		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-002	10603314	2026-02-02	U-3337		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-002	7772243	2032-09-27		Drug substance, Drug product	2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-003	10596162	2026-02-02	U-3338		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-003	10603314	2026-02-02	U-3337		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211288-003	7772243	2032-09-27		Drug substance, Drug product	2018-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-001	8623883	2025-05-05	U-1403		2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-001	10596162	2026-02-02	U-3338		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-001	10603314	2026-02-02	U-3337		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-001	7772243	2028-05-05		Drug substance, Drug product	2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	8623883	2025-05-05	U-1403		2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	10596162	2026-02-02	U-3338		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	10603314	2026-02-02	U-3337		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	7772243	2028-05-05		Drug substance, Drug product	2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	8623883	2025-05-05	U-1403		2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	10596162	2026-02-02	U-3338		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	10603314	2026-02-02	U-3337		2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	7772243	2028-05-05		Drug substance, Drug product	2018-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211288-001	8623883	2025-05-05	U-1403		2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-001	10596162	2026-02-02	U-3338		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-001	10603314	2026-02-02	U-3337		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-001	7772243	2028-05-05		Drug substance, Drug product	2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	8623883	2025-05-05	U-1403		2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	10596162	2026-02-02	U-3338		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	10603314	2026-02-02	U-3337		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	7772243	2028-05-05		Drug substance, Drug product	2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	8623883	2025-05-05	U-1403		2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	10596162	2026-02-02	U-3338		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	10603314	2026-02-02	U-3337		2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	7772243	2028-05-05		Drug substance, Drug product	2018-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	8623883	2025-05-05	U-1403		2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	10596162	2026-02-02	U-3338		2022-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	10603314	2026-02-02	U-3337		2022-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	7772243	2028-08-26		Drug substance, Drug product	2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-002	8623883	2025-05-05	U-1403		2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-002	10596162	2026-02-02	U-3338		2022-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-002	10603314	2026-02-02	U-3337		2022-04-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 306 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	N211288-001	ODE-206	2025-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-001	ODE-213	2025-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	ODE-206	2025-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-002	ODE-213	2025-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	ODE-206	2025-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211288-003	ODE-213	2025-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211288-001	ODE-206	2025-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-001	ODE-213	2025-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	ODE-206	2025-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-002	ODE-213	2025-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	ODE-206	2025-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211288-003	ODE-213	2025-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	ODE-206	2025-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-001	ODE-213	2025-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-002	ODE-206	2025-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-002	ODE-213	2025-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-003	ODE-206	2025-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211288-003	ODE-213	2025-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-001	ODE-206	2025-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-001	ODE-213	2025-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-002	ODE-206	2025-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-002	ODE-213	2025-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-003	ODE-206	2025-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211288-003	ODE-213	2025-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-001	ODE-206	2025-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-001	ODE-213	2025-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-002	ODE-206	2025-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-002	ODE-213	2025-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-003	ODE-206	2025-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211288-003	ODE-213	2025-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-001	ODE-206	2025-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-001	ODE-213	2025-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-002	ODE-206	2025-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-002	ODE-213	2025-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-003	ODE-206	2025-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211288-003	ODE-213	2025-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-001	ODE-206	2025-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-001	ODE-213	2025-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-002	ODE-206	2025-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211288-002	ODE-213	2025-09-27	`5bbf6a4d5a75…`

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
Vizimpro	DACOMITINIB	Pfizer Laboratories Div Pfizer Inc	4ab27d2f-e385-4e9c-b324-fa69c10b855a	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211288 application number: NDA211288 ndc (product): 0069-2299 ndc (product): 0069-1198 ndc (product): 0069-0197

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0197	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0197	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0197	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1198	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1198	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1198	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2299	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2299	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2299	Vizimpro	dacomitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-197	Vizimpro	dacomitinib	U.S. Pharmaceuticals	NDA	Current
63539-197	Vizimpro	dacomitinib	U.S. Pharmaceuticals	NDA	Current
63539-197	Vizimpro	dacomitinib	U.S. Pharmaceuticals	NDA	Current
63539-197	Vizimpro	dacomitinib	U.S. Pharmaceuticals	NDA	Current
63539-197	Vizimpro	dacomitinib	U.S. Pharmaceuticals	NDA	Current
63539-197	Vizimpro	dacomitinib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65735	SUPPL	2020-12-23
65681	SUPPL	2020-12-22
56168	ORIG	2018-10-30
55640	ORIG	2018-09-27
55639	ORIG	2018-09-27