Application 203756

Type: NDA
Sponsor: EXELIXIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMETRIQ	CABOZANTINIB S-MALATE	CAPSULE;ORAL	EQ 20MG BASE	Yes	Yes
002	COMETRIQ	CABOZANTINIB S-MALATE	CAPSULE;ORAL	EQ 80MG BASE	Yes	No

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

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
N203756-001	COMETRIQ	CABOZANTINIB S-MALATE	EQ 20MG BASE	CAPSULE / ORAL		RLD	2012-11-29
N203756-002	COMETRIQ	CABOZANTINIB S-MALATE	EQ 80MG BASE	CAPSULE / ORAL		RLD, RS	2012-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26
N203756-001	11091439	2030-01-15		Drug substance	2021-08-31
N203756-001	11091440	2030-01-15		Drug product	2021-08-31
N203756-001	11098015	2030-01-15	U-1617		2021-08-31
N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04
N203756-001	11298349	2032-02-10		Drug product	2022-04-12
N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25
N203756-001	9717720	2032-02-10		Drug product	2017-08-23
N203756-002	7579473	2026-08-14		Drug substance, Drug product
N203756-002	11091439	2030-01-15		Drug substance	2021-08-31
N203756-002	11091440	2030-01-15		Drug product	2021-08-31
N203756-002	11098015	2030-01-15	U-1617		2021-08-31
N203756-002	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04
N203756-002	11298349	2032-02-10		Drug product	2022-04-12
N203756-002	12128039	2032-02-10	U-1617	Drug product	2024-11-25
N203756-002	9717720	2032-02-10		Drug product	2017-08-23

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 · 86 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	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 550 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	N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11091439	2030-01-15		Drug substance	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11091440	2030-01-15		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11098015	2030-01-15	U-1617		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11298349	2032-02-10		Drug product	2022-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	9717720	2032-02-10		Drug product	2017-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	7579473	2026-08-14		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11091439	2030-01-15		Drug substance	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11091440	2030-01-15		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11098015	2030-01-15	U-1617		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11298349	2032-02-10		Drug product	2022-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	9717720	2032-02-10		Drug product	2017-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11091439	2030-01-15		Drug substance	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11091440	2030-01-15		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11098015	2030-01-15	U-1617		2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11298349	2032-02-10		Drug product	2022-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	9717720	2032-02-10		Drug product	2017-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	7579473	2026-08-14		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11091439	2030-01-15		Drug substance	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11091440	2030-01-15		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11098015	2030-01-15	U-1617		2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11298349	2032-02-10		Drug product	2022-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	9717720	2032-02-10		Drug product	2017-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11091439	2030-01-15		Drug substance	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11091440	2030-01-15		Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11098015	2030-01-15	U-1617		2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11298349	2032-02-10		Drug product	2022-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	9717720	2032-02-10		Drug product	2017-08-23	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203756-001	ODE-33	2019-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203756-002	ODE-33	2019-11-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N203756-001	ODE-33	2019-11-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203756-002	ODE-33	2019-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203756-001	ODE-33	2019-11-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203756-002	ODE-33	2019-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203756-001	ODE-33	2019-11-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203756-002	ODE-33	2019-11-29	`ea99ee380514…`

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
COMETRIQ	CABOZANTINIB	Exelixis, Inc.	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	2025-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203756 application number: NDA203756 ndc (product): 42388-012 ndc (product): 42388-013 ndc (product): 42388-011

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83723	SUPPL	2025-10-10
83712	SUPPL	2025-10-09
75283	SUPPL	2023-08-24
75275	SUPPL	2023-08-24
69511	SUPPL	2021-12-07
65036	SUPPL	2020-10-27
64992	SUPPL	2020-10-23
61762	SUPPL	2020-02-04
61759	SUPPL	2020-02-03
51071	SUPPL	2018-01-17
51057	SUPPL	2018-01-17
49975	SUPPL	2017-10-06
49961	SUPPL	2017-10-06
32465	SUPPL	2016-05-24
40326	SUPPL	2016-05-23
43443	ORIG	2013-01-04
24448	ORIG	2013-01-04
40325	ORIG	2012-11-30
10248	ORIG	2012-11-30