Application 212888

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CABENUVA	CABOTEGRAVIR;RILPIVIRINE	TABLET, FILM COATED	30MG	No	No
002	CABENUVA	CABOTEGRAVIR;RILPIVIRINE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	600MG/3ML; 900MG/3ML	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
N212888-001	CABENUVA KIT	CABOTEGRAVIR; RILPIVIRINE	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2021-01-21
N212888-002	CABENUVA KIT	CABOTEGRAVIR; RILPIVIRINE	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2021-01-21

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22
N212888-001	11389447	2027-06-30	U-3405		2022-08-17
N212888-001	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16
N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15
N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05
N212888-001	RE50189	2031-11-27	U-3348		2024-12-16
N212888-001	11389448	2032-04-13		Drug product	2025-04-30
N212888-001	12178815	2038-07-18	U-3348		2025-01-13
N212888-001	12636285	2040-10-01	U-3348		2026-06-10
N212888-001	12636286	2040-10-01	U-3348		2026-06-10
N212888-002	10927129	2026-04-28		Drug substance, Drug product	2021-03-22
N212888-002	11389447	2027-06-30	U-3405		2022-08-17
N212888-002	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16
N212888-002	11224597	2031-09-15	U-3348	Drug product	2022-02-15
N212888-002	12138264	2031-09-15	U-3348	Drug product	2024-12-05
N212888-002	RE50189	2031-11-27	U-3348		2024-12-16
N212888-002	11389448	2032-04-13		Drug product	2025-04-30
N212888-002	12178815	2038-07-18	U-3348		2025-01-13
N212888-002	12636285	2040-10-01	U-3348		2026-06-10
N212888-002	12636286	2040-10-01	U-3348		2026-06-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212888-001	NCE	2026-01-21
N212888-002	NCE	2026-01-21

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 · 70 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	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 408 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	N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	11389447	2027-06-30	U-3405		2022-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	RE50189	2031-11-27	U-3348		2024-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	11389448	2032-04-13		Drug product	2025-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	12178815	2038-07-18	U-3348		2025-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	11389447	2027-06-30	U-3405		2022-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	RE50189	2031-11-27	U-3348		2024-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	11389448	2032-04-13		Drug product	2025-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	12178815	2038-07-18	U-3348		2025-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	7125879	2025-04-21	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	11389447	2027-06-30	U-3405		2022-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	RE50189	2031-11-27	U-3348		2024-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	11389448	2032-04-13		Drug product	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	12178815	2038-07-18	U-3348		2025-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	7125879	2025-04-21	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	11389447	2027-06-30	U-3405		2022-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	RE50189	2031-11-27	U-3348		2024-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	11389448	2032-04-13		Drug product	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	12178815	2038-07-18	U-3348		2025-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212888-001	7125879	2025-04-21	U-3348	Drug substance, Drug product	2021-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	8410103	2026-04-28	U-3348	Drug substance, Drug product	2021-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	11389447	2027-06-30	U-3405		2022-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 178 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	N212888-001	NCE	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	NCE	2026-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	D-184	2025-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	NPP	2025-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	NCE	2026-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	D-184	2025-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	NPP	2025-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	NCE	2026-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212888-001	D-184	2025-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	NPP	2025-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	NCE	2026-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	D-184	2025-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	NPP	2025-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	NCE	2026-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	D-184	2025-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	NPP	2025-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	NCE	2026-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	D-184	2025-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	NPP	2025-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	NCE	2026-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	D-184	2025-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	NPP	2025-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	NCE	2026-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	D-184	2025-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	NPP	2025-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	NCE	2026-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	D-184	2025-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	NPP	2025-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	NCE	2026-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	D-184	2025-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	NPP	2025-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	NCE	2026-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	D-184	2025-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	NPP	2025-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	NCE	2026-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	D-184	2025-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	NPP	2025-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	NCE	2026-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-001	D-184	2025-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-001	NPP	2025-03-29	`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
Cabenuva	CABOTEGRAVIR AND RILPIVIRINE	ViiV Healthcare Company	1698baf3-f895-4c42-a1b1-e9ee3f20da36	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212888 application number: NDA212888 ndc (product): 49702-240 ndc (product): 49702-253

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-240	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current
49702-253	Cabenuva	cabotegravir and rilpivirine	ViiV Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84337	SUPPL	2025-11-28
84336	SUPPL	2025-11-28
82009	SUPPL	2025-04-25
81944	SUPPL	2025-04-21
79750	SUPPL	2024-09-26
79717	SUPPL	2024-09-24
76831	SUPPL	2023-12-14
76811	SUPPL	2023-12-14
73625	SUPPL	2023-02-28
73618	SUPPL	2023-02-28
70661	SUPPL	2022-03-30
70660	SUPPL	2022-03-30
70653	SUPPL	2022-03-30
70652	SUPPL	2022-03-30
70598	SUPPL	2022-03-25
70595	SUPPL	2022-03-24
70143	SUPPL	2022-02-10
70135	SUPPL	2022-02-09
70060	SUPPL	2022-02-03
70044	SUPPL	2022-02-01
66474	ORIG	2021-03-03
65999	ORIG	2021-01-26
65964	ORIG	2021-01-22