Application 213591

Type: NDA
Sponsor: NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TABRECTA	CAPMATINIB HYDROCHLORIDE	TABLET;ORAL	150MG	Yes	No
002	TABRECTA	CAPMATINIB HYDROCHLORIDE	TABLET;ORAL	200MG	Yes	No

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
N213591-001	TABRECTA	CAPMATINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		RLD	2020-05-06
N213591-002	TABRECTA	CAPMATINIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2020-05-06

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213591-001	12084449	2027-11-19	U-2813		2024-10-02
N213591-001	8461330	2027-11-19		Drug substance, Drug product	2020-05-26
N213591-001	8901123	2029-05-20	U-2813		2020-05-26
N213591-001	8420645	2031-06-05		Drug substance, Drug product	2020-05-26
N213591-001	7767675	2032-11-19		Drug substance, Drug product	2020-05-26
N213591-001	10596178	2035-07-22		Drug product	2020-06-26
N213591-001	12208101	2035-07-22		Drug product	2025-02-03
N213591-002	12084449	2027-11-19	U-2813		2024-10-02
N213591-002	8461330	2027-11-19		Drug substance, Drug product	2020-05-26
N213591-002	8901123	2029-05-20	U-2813		2020-05-26
N213591-002	8420645	2031-06-05		Drug substance, Drug product	2020-05-26
N213591-002	7767675	2032-11-19		Drug substance, Drug product	2020-05-26
N213591-002	10596178	2035-07-22		Drug product	2020-06-26
N213591-002	12208101	2035-07-22		Drug product	2025-02-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213591-001	ODE-291	2027-05-06
N213591-002	ODE-291	2027-05-06

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 2 · 74 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	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213591-001	TABRECTA	EQ 150MG BASE	TABLET / ORAL	RLD	2020-05-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213591-002	TABRECTA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2020-05-06	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 402 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	N213591-001	12084449	2027-11-19	U-2813		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-001	8461330	2027-11-19		Drug substance, Drug product	2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-001	8901123	2029-05-20	U-2813		2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-001	8420645	2031-06-05		Drug substance, Drug product	2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-001	7767675	2032-11-19		Drug substance, Drug product	2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-001	10596178	2035-07-22		Drug product	2020-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-001	12208101	2035-07-22		Drug product	2025-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	12084449	2027-11-19	U-2813		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	8461330	2027-11-19		Drug substance, Drug product	2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	8901123	2029-05-20	U-2813		2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	8420645	2031-06-05		Drug substance, Drug product	2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	7767675	2032-11-19		Drug substance, Drug product	2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	10596178	2035-07-22		Drug product	2020-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	12208101	2035-07-22		Drug product	2025-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	12084449	2027-11-19	U-2813		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	8461330	2027-11-19		Drug substance, Drug product	2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	8901123	2029-05-20	U-2813		2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	8420645	2031-06-05		Drug substance, Drug product	2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	7767675	2032-11-19		Drug substance, Drug product	2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	10596178	2035-07-22		Drug product	2020-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	12208101	2035-07-22		Drug product	2025-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	12084449	2027-11-19	U-2813		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	8461330	2027-11-19		Drug substance, Drug product	2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	8901123	2029-05-20	U-2813		2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	8420645	2031-06-05		Drug substance, Drug product	2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	7767675	2032-11-19		Drug substance, Drug product	2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	10596178	2035-07-22		Drug product	2020-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	12208101	2035-07-22		Drug product	2025-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213591-001	12084449	2027-11-19	U-2813		2024-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	8461330	2027-11-19		Drug substance, Drug product	2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	8901123	2029-05-20	U-2813		2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	8420645	2031-06-05		Drug substance, Drug product	2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	7767675	2032-11-19		Drug substance, Drug product	2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	10596178	2035-07-22		Drug product	2020-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	12208101	2035-07-22		Drug product	2025-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	12084449	2027-11-19	U-2813		2024-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	8461330	2027-11-19		Drug substance, Drug product	2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	8901123	2029-05-20	U-2813		2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	8420645	2031-06-05		Drug substance, Drug product	2020-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	7767675	2032-11-19		Drug substance, Drug product	2020-05-26	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213591-001	ODE-291	2027-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213591-002	ODE-291	2027-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	NCE	2025-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-001	ODE-291	2027-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	NCE	2025-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213591-002	ODE-291	2027-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213591-001	NCE	2025-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-001	ODE-291	2027-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	NCE	2025-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213591-002	ODE-291	2027-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213591-001	NCE	2025-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213591-001	ODE-291	2027-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213591-002	NCE	2025-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213591-002	ODE-291	2027-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213591-001	NCE	2025-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213591-001	ODE-291	2027-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213591-002	NCE	2025-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213591-002	ODE-291	2027-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213591-001	NCE	2025-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213591-001	ODE-291	2027-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213591-002	NCE	2025-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213591-002	ODE-291	2027-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213591-001	NCE	2025-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213591-001	ODE-291	2027-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213591-002	NCE	2025-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213591-002	ODE-291	2027-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213591-001	NCE	2025-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213591-001	ODE-291	2027-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213591-002	NCE	2025-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213591-002	ODE-291	2027-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213591-001	NCE	2025-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213591-001	ODE-291	2027-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213591-002	NCE	2025-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213591-002	ODE-291	2027-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213591-001	NCE	2025-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213591-001	ODE-291	2027-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213591-002	NCE	2025-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213591-002	ODE-291	2027-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213591-001	NCE	2025-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213591-001	ODE-291	2027-05-06	`79d66fd596c7…`

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
TABRECTA	CAPMATINIB	Novartis Pharmaceuticals Corporation	455892c3-d144-4ba8-9ab4-79cabff9876d	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213591 application number: NDA213591 ndc (product): 0078-0709 ndc (product): 0078-0716

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0709	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0709	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0709	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0709	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0716	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0716	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0716	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0716	TABRECTA	capmatinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77892	SUPPL	2024-03-21
77847	SUPPL	2024-03-15
73884	SUPPL	2023-03-27
73872	SUPPL	2023-03-27
71789	SUPPL	2022-08-11
71769	SUPPL	2022-08-11
69968	SUPPL	2022-01-25
69959	SUPPL	2022-01-25
63374	ORIG	2020-06-01
62845	ORIG	2020-05-07
62842	ORIG	2020-05-06