Application 213736

Type: NDA
Sponsor: INCYTE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMAZYRE	PEMIGATINIB	TABLET;ORAL	4.5MG	Yes	No
002	PEMAZYRE	PEMIGATINIB	TABLET;ORAL	9MG	Yes	No
003	PEMAZYRE	PEMIGATINIB	TABLET;ORAL	13.5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N213736-001	PEMAZYRE	PEMIGATINIB	4.5MG	TABLET / ORAL	RLD	2020-04-17
N213736-002	PEMAZYRE	PEMIGATINIB	9MG	TABLET / ORAL	RLD	2020-04-17
N213736-003	PEMAZYRE	PEMIGATINIB	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213736-001	10131667	2034-04-17	U-2809		2020-05-14
N213736-001	9611267	2035-01-30		Drug substance, Drug product	2020-05-14
N213736-001	11466004	2039-05-03	U-3464		2022-11-07
N213736-001	11466004	2039-05-03	U-3465		2022-11-07
N213736-001	11466004	2039-05-03	U-3466		2022-11-07
N213736-001	11628162	2040-08-30	U-3568		2023-05-15
N213736-001	11628162	2040-08-30	U-3569		2023-05-15
N213736-001	11628162	2040-08-30	U-3570		2023-05-15
N213736-001	11628162	2040-08-30	U-3571		2023-05-15
N213736-001	12552792	2040-10-03		Drug substance, Drug product	2026-03-18
N213736-002	10131667	2034-04-17	U-2809		2020-05-14
N213736-002	9611267	2035-01-30		Drug substance, Drug product	2020-05-14
N213736-002	11466004	2039-05-03	U-3464		2022-11-07
N213736-002	11466004	2039-05-03	U-3465		2022-11-07
N213736-002	11466004	2039-05-03	U-3466		2022-11-07
N213736-002	11628162	2040-08-30	U-3568		2023-05-15
N213736-002	11628162	2040-08-30	U-3569		2023-05-15
N213736-002	11628162	2040-08-30	U-3570		2023-05-15
N213736-002	11628162	2040-08-30	U-3571		2023-05-15
N213736-002	12552792	2040-10-03		Drug substance, Drug product	2026-03-18
N213736-003	10131667	2034-04-17	U-2809		2020-05-14
N213736-003	9611267	2035-01-30		Drug substance, Drug product	2020-05-14
N213736-003	11466004	2039-05-03	U-3464		2022-11-07
N213736-003	11466004	2039-05-03	U-3465		2022-11-07
N213736-003	11466004	2039-05-03	U-3466		2022-11-07
N213736-003	11628162	2040-08-30	U-3568		2023-05-15
N213736-003	11628162	2040-08-30	U-3569		2023-05-15
N213736-003	11628162	2040-08-30	U-3570		2023-05-15
N213736-003	11628162	2040-08-30	U-3571		2023-05-15
N213736-003	12552792	2040-10-03		Drug substance, Drug product	2026-03-18

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213736-001	ODE-292	2027-04-17
N213736-001	ODE-404	2029-08-26
N213736-002	ODE-292	2027-04-17
N213736-002	ODE-404	2029-08-26
N213736-003	ODE-292	2027-04-17
N213736-003	ODE-404	2029-08-26

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 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213736-002	PEMAZYRE	9MG	TABLET / ORAL	RLD	2020-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213736-003	PEMAZYRE	13.5MG	TABLET / ORAL	RLD, RS	2020-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213736-001	PEMAZYRE	4.5MG	TABLET / ORAL	RLD	2020-04-17	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 774 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213736-001	10131667	2034-04-17	U-2809		2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11466004	2039-05-03	U-3464		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11466004	2039-05-03	U-3465		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11466004	2039-05-03	U-3466		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3568		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3569		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3570		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	11628162	2040-08-30	U-3571		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	10131667	2034-04-17	U-2809		2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11466004	2039-05-03	U-3464		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11466004	2039-05-03	U-3465		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11466004	2039-05-03	U-3466		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3568		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3569		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3570		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	11628162	2040-08-30	U-3571		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	10131667	2034-04-17	U-2809		2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11466004	2039-05-03	U-3464		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11466004	2039-05-03	U-3465		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11466004	2039-05-03	U-3466		2022-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3569		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3568		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3570		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	11628162	2040-08-30	U-3571		2023-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213736-001	10131667	2034-04-17	U-2809		2020-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	9611267	2035-01-30		Drug substance, Drug product	2020-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11466004	2039-05-03	U-3464		2022-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11466004	2039-05-03	U-3465		2022-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11466004	2039-05-03	U-3466		2022-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3568		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3569		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3570		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	11628162	2040-08-30	U-3571		2023-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	12552792	2040-10-03		Drug substance, Drug product	2026-03-18	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213736-001	ODE-292	2027-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-001	ODE-404	2029-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	ODE-292	2027-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-002	ODE-404	2029-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	ODE-292	2027-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213736-003	ODE-404	2029-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213736-001	ODE-292	2027-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-001	ODE-404	2029-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-002	ODE-292	2027-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-002	ODE-404	2029-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-003	ODE-292	2027-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213736-003	ODE-404	2029-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213736-001	ODE-292	2027-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-001	ODE-404	2029-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-002	ODE-292	2027-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-002	ODE-404	2029-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-003	ODE-292	2027-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213736-003	ODE-404	2029-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	NCE	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	I-899	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	ODE-292	2027-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-001	ODE-404	2029-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	NCE	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	I-899	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	ODE-292	2027-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-002	ODE-404	2029-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	NCE	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	I-899	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	ODE-292	2027-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213736-003	ODE-404	2029-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213736-001	NCE	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-001	I-899	2025-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-001	ODE-292	2027-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-001	ODE-404	2029-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	NCE	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	I-899	2025-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	ODE-292	2027-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-002	ODE-404	2029-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-003	NCE	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213736-003	I-899	2025-08-26	`6a471c1ec25d…`

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
PEMAZYRE	PEMIGATINIB	Incyte Corporation	9e1f2222-1d89-4e63-989c-ccebe2ab1eb4	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213736 application number: NDA213736 ndc (product): 50881-026 ndc (product): 50881-028 ndc (product): 50881-027

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
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71940	SUPPL	2022-08-29
71937	SUPPL	2022-08-26
66346	SUPPL	2021-02-24
66341	SUPPL	2021-02-24
63054	ORIG	2020-05-18
62595	ORIG	2020-04-20
62593	ORIG	2020-04-20