Application 208692

Type: NDA
Sponsor: EXELIXIS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CABOMETYX	CABOZANTINIB S-MALATE	TABLET;ORAL	EQ 20MG BASE	Yes	No
002	CABOMETYX	CABOZANTINIB S-MALATE	TABLET;ORAL	EQ 40MG BASE	Yes	No
003	CABOMETYX	CABOZANTINIB S-MALATE	TABLET;ORAL	EQ 60MG BASE	Yes	Yes

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	TE codes	RLD / RS	Approval date
N208692-001	CABOMETYX	CABOZANTINIB S-MALATE	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2016-04-25
N208692-002	CABOMETYX	CABOZANTINIB S-MALATE	EQ 40MG BASE	TABLET / ORAL	AB	RLD	2016-04-25
N208692-003	CABOMETYX	CABOZANTINIB S-MALATE	EQ 60MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N208692-001	AB
N208692-002	AB
N208692-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208692-001	7579473	2026-08-14		Drug substance, Drug product	2016-05-24
N208692-001	11091439	2030-01-15		Drug substance	2021-08-31
N208692-001	11091440	2030-01-15		Drug product	2021-08-31
N208692-001	11098015	2030-01-15	U-1220		2021-08-31
N208692-001	11098015	2030-01-15	U-1480		2021-08-31
N208692-001	11098015	2030-01-15	U-2488		2021-08-31
N208692-001	11098015	2030-01-15	U-3225		2021-08-31
N208692-001	11098015	2030-01-15	U-4131		2021-08-31
N208692-001	11098015	2030-01-15	U-4156		2021-08-31
N208692-001	8877776	2030-10-08	U-3225	Drug substance, Drug product	2016-05-24
N208692-001	10034873	2031-07-18	U-2488		2019-02-12
N208692-001	10039757	2031-07-18	U-1480		2018-09-06
N208692-001	11298349	2032-02-10		Drug product	2022-04-12
N208692-001	12128039	2032-02-10	U-1220	Drug product	2024-11-25
N208692-001	12128039	2032-02-10	U-1480	Drug product	2024-11-25
N208692-001	12128039	2032-02-10	U-2488	Drug product	2024-11-25
N208692-001	12128039	2032-02-10	U-3225	Drug product	2024-11-25
N208692-001	12128039	2032-02-10	U-4131	Drug product	2024-11-25
N208692-001	12128039	2032-02-10	U-4156	Drug product	2024-11-25
N208692-001	9724342	2033-07-09		Drug product	2017-08-25
N208692-002	7579473	2026-08-14		Drug substance, Drug product	2016-05-24
N208692-002	11091439	2030-01-15		Drug substance	2021-08-31
N208692-002	11091440	2030-01-15		Drug product	2021-08-31
N208692-002	11098015	2030-01-15	U-1220		2021-08-31
N208692-002	11098015	2030-01-15	U-1480		2021-08-31
N208692-002	11098015	2030-01-15	U-2488		2021-08-31
N208692-002	11098015	2030-01-15	U-3225		2021-08-31
N208692-002	11098015	2030-01-15	U-4131		2021-08-31
N208692-002	11098015	2030-01-15	U-4156		2021-08-31
N208692-002	8877776	2030-10-08	U-3225	Drug substance, Drug product	2016-05-24
N208692-002	10034873	2031-07-18	U-2488		2019-02-12
N208692-002	10039757	2031-07-18	U-1480		2018-09-06
N208692-002	11298349	2032-02-10		Drug product	2022-04-12
N208692-002	12128039	2032-02-10	U-1220	Drug product	2024-11-25
N208692-002	12128039	2032-02-10	U-1480	Drug product	2024-11-25
N208692-002	12128039	2032-02-10	U-2488	Drug product	2024-11-25
N208692-002	12128039	2032-02-10	U-3225	Drug product	2024-11-25
N208692-002	12128039	2032-02-10	U-4131	Drug product	2024-11-25
N208692-002	12128039	2032-02-10	U-4156	Drug product	2024-11-25
N208692-002	9724342	2033-07-09		Drug product	2017-08-25
N208692-003	7579473	2026-08-14		Drug substance, Drug product	2016-05-24
N208692-003	11091439	2030-01-15		Drug substance	2021-08-31
N208692-003	11091440	2030-01-15		Drug product	2021-08-31
N208692-003	11098015	2030-01-15	U-1220		2021-08-31
N208692-003	11098015	2030-01-15	U-1480		2021-08-31
N208692-003	11098015	2030-01-15	U-2488		2021-08-31
N208692-003	11098015	2030-01-15	U-3225		2021-08-31
N208692-003	11098015	2030-01-15	U-4131		2021-08-31
N208692-003	11098015	2030-01-15	U-4156		2021-08-31
N208692-003	8877776	2030-10-08	U-3225	Drug substance, Drug product	2016-05-24
N208692-003	10034873	2031-07-18	U-2488		2019-02-12
N208692-003	10039757	2031-07-18	U-1480		2018-09-06
N208692-003	11298349	2032-02-10		Drug product	2022-04-12
N208692-003	12128039	2032-02-10	U-1220	Drug product	2024-11-25
N208692-003	12128039	2032-02-10	U-1480	Drug product	2024-11-25
N208692-003	12128039	2032-02-10	U-2488	Drug product	2024-11-25
N208692-003	12128039	2032-02-10	U-3225	Drug product	2024-11-25
N208692-003	12128039	2032-02-10	U-4131	Drug product	2024-11-25
N208692-003	12128039	2032-02-10	U-4156	Drug product	2024-11-25
N208692-003	9724342	2033-07-09		Drug product	2017-08-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208692-001	ODE-227	2026-01-14
N208692-001	ODE-375	2028-09-17
N208692-001	ODE-530	2032-03-26
N208692-002	ODE-227	2026-01-14
N208692-002	ODE-375	2028-09-17
N208692-002	ODE-530	2032-03-26
N208692-003	ODE-227	2026-01-14
N208692-003	ODE-375	2028-09-17
N208692-003	ODE-530	2032-03-26

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2016-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL	AB	RLD	2016-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208692-002	CABOMETYX	EQ 40MG BASE	TABLET / ORAL		RLD	2016-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208692-003	CABOMETYX	EQ 60MG BASE	TABLET / ORAL		RLD, RS	2016-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208692-001	CABOMETYX	EQ 20MG BASE	TABLET / ORAL		RLD	2016-04-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N208692-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-003	AB	1	`84e616aacf4f…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,902 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	N208692-001	7579473	2026-08-14		Drug substance, Drug product	2016-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11091439	2030-01-15		Drug substance	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11091440	2030-01-15		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11098015	2030-01-15	U-4131		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11098015	2030-01-15	U-4156		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11098015	2030-01-15	U-2488		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11098015	2030-01-15	U-1220		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11098015	2030-01-15	U-1480		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11098015	2030-01-15	U-3225		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	8877776	2030-10-08	U-3225	Drug substance, Drug product	2016-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	10034873	2031-07-18	U-2488		2019-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	10039757	2031-07-18	U-1480		2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	11298349	2032-02-10		Drug product	2022-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	12128039	2032-02-10	U-1220	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	12128039	2032-02-10	U-1480	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	12128039	2032-02-10	U-2488	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	12128039	2032-02-10	U-3225	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	12128039	2032-02-10	U-4131	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	12128039	2032-02-10	U-4156	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-001	9724342	2033-07-09		Drug product	2017-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	7579473	2026-08-14		Drug substance, Drug product	2016-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11091439	2030-01-15		Drug substance	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11091440	2030-01-15		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11098015	2030-01-15	U-4156		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11098015	2030-01-15	U-4131		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11098015	2030-01-15	U-2488		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11098015	2030-01-15	U-1220		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11098015	2030-01-15	U-1480		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11098015	2030-01-15	U-3225		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	8877776	2030-10-08	U-3225	Drug substance, Drug product	2016-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	10034873	2031-07-18	U-2488		2019-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	10039757	2031-07-18	U-1480		2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	11298349	2032-02-10		Drug product	2022-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	12128039	2032-02-10	U-1220	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	12128039	2032-02-10	U-1480	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	12128039	2032-02-10	U-2488	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	12128039	2032-02-10	U-3225	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	12128039	2032-02-10	U-4156	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	12128039	2032-02-10	U-4131	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208692-002	9724342	2033-07-09		Drug product	2017-08-25	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 13 · 489 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208692-003	ODE-227	2026-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208692-003	ODE-375	2028-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-001	ODE-227	2026-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-001	ODE-375	2028-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-002	ODE-227	2026-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-002	ODE-375	2028-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-003	ODE-227	2026-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208692-003	ODE-375	2028-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-001	I-854	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-001	I-873	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-001	ODE-227	2026-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-001	ODE-375	2028-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-002	I-854	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-002	I-873	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-002	ODE-227	2026-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-002	ODE-375	2028-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-003	I-854	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-003	I-873	2024-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-003	ODE-227	2026-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208692-003	ODE-375	2028-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-001	I-854	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-001	I-873	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-001	ODE-227	2026-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-001	ODE-375	2028-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-002	I-854	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-002	I-873	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-002	ODE-227	2026-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-002	ODE-375	2028-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-003	I-854	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-003	I-873	2024-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-003	ODE-227	2026-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208692-003	ODE-375	2028-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-001	I-854	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-001	I-873	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-001	ODE-227	2026-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-001	ODE-375	2028-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-002	I-854	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-002	I-873	2024-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-002	ODE-227	2026-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208692-002	ODE-375	2028-09-17	`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
CABOMETYX	CABOZANTINIB	Exelixis, Inc.	3850cce2-6137-42e5-a792-d318c4a4b3b5	2025-10-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208692 application number: NDA208692 ndc (product): 42388-025 ndc (product): 42388-023 ndc (product): 42388-024

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83818	SUPPL	2025-10-20
83713	SUPPL	2025-10-09
83332	SUPPL	2025-09-11
83327	SUPPL	2025-09-11
81763	SUPPL	2025-03-28
81733	SUPPL	2025-03-26
75528	SUPPL	2023-09-21
75523	SUPPL	2023-09-21
73505	SUPPL	2023-02-15
73492	SUPPL	2023-02-14
71569	SUPPL	2022-07-15
71559	SUPPL	2022-07-15
68715	SUPPL	2021-09-22
68657	SUPPL	2021-09-20
66996	SUPPL	2021-04-07
66819	SUPPL	2021-03-19
65990	SUPPL	2021-01-26
65959	SUPPL	2021-01-22
63968	SUPPL	2020-07-20
63945	SUPPL	2020-07-17
61760	SUPPL	2020-02-04
61758	SUPPL	2020-02-03
57252	SUPPL	2019-01-18
57217	SUPPL	2019-01-15
51047	ORIG	2018-01-12
50903	SUPPL	2017-12-27
50776	SUPPL	2017-12-19
50443	SUPPL	2017-11-17
32914	ORIG	2016-04-27
24133	ORIG	2016-04-27
40637	ORIG	2016-04-25