Application 022128

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SELZENTRY	MARAVIROC	TABLET;ORAL	150MG	Yes	No
002	SELZENTRY	MARAVIROC	TABLET;ORAL	300MG	Yes	Yes
003	SELZENTRY	MARAVIROC	TABLET;ORAL	25MG	Yes	No
004	SELZENTRY	MARAVIROC	TABLET;ORAL	75MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022128-001	SELZENTRY	MARAVIROC	150MG	TABLET / ORAL	AB	RLD	2007-08-06
N022128-002	SELZENTRY	MARAVIROC	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06
N022128-003	SELZENTRY	MARAVIROC	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04
N022128-004	SELZENTRY	MARAVIROC	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022128-001	AB
N022128-002	AB

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022128-003	SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022128-004	SELZENTRY	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022128-003	SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022128-004	SELZENTRY	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022128-003	SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022128-004	SELZENTRY	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022128-003	SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022128-004	SELZENTRY	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022128-003	SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022128-004	SELZENTRY	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022128-003	SELZENTRY	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022128-004	SELZENTRY	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2016-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022128-003	SELZENTRY	25MG	TABLET / ORAL		RLD	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022128-004	SELZENTRY	75MG	TABLET / ORAL		RLD	2016-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022128-003	SELZENTRY	25MG	TABLET / ORAL		RLD	2016-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022128-004	SELZENTRY	75MG	TABLET / ORAL		RLD	2016-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022128-003	SELZENTRY	25MG	TABLET / ORAL		RLD	2016-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022128-004	SELZENTRY	75MG	TABLET / ORAL		RLD	2016-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022128-001	SELZENTRY	150MG	TABLET / ORAL	AB	RLD	2007-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022128-002	SELZENTRY	300MG	TABLET / ORAL	AB	RLD, RS	2007-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022128-003	SELZENTRY	25MG	TABLET / ORAL		RLD	2016-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022128-004	SELZENTRY	75MG	TABLET / ORAL		RLD	2016-11-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022128-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022128-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022128-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022128-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022128-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022128-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022128-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022128-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022128-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022128-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022128-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022128-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022128-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022128-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022128-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022128-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022128-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022128-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022128-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022128-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022128-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022128-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022128-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022128-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022128-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022128-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022128-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022128-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022128-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022128-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022128-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022128-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022128-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022128-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022128-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022128-002	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 316 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-001	6667314*PED	2022-02-06		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-001	7368460	2022-11-25	U-824			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-001	7368460*PED	2023-05-25		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-002	6667314*PED	2022-02-06		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-002	7368460	2022-11-25	U-824			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-002	7368460*PED	2023-05-25		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-003	6667314*PED	2022-02-06		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-003	7368460	2022-11-25	U-824		2016-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-003	7368460*PED	2023-05-25		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-004	6667314*PED	2022-02-06		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-004	7368460	2022-11-25	U-824		2016-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022128-004	7368460*PED	2023-05-25		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022128-001	6667314*PED	2022-02-06		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-001	7368460	2022-11-25	U-824			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-001	7368460*PED	2023-05-25		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-002	6667314*PED	2022-02-06		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-002	7368460	2022-11-25	U-824			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-002	7368460*PED	2023-05-25		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-003	6667314*PED	2022-02-06		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-003	7368460	2022-11-25	U-824		2016-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-003	7368460*PED	2023-05-25		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-004	6667314*PED	2022-02-06		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-004	7368460	2022-11-25	U-824		2016-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022128-004	7368460*PED	2023-05-25		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022128-001	6667314*PED	2022-02-06		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-001	7368460	2022-11-25	U-824			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-001	7368460*PED	2023-05-25		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-002	6667314*PED	2022-02-06		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-002	7368460	2022-11-25	U-824			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-002	7368460*PED	2023-05-25		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-003	6667314*PED	2022-02-06		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-003	7368460	2022-11-25	U-824		2016-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-003	7368460*PED	2023-05-25		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-004	6667314*PED	2022-02-06		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-004	7368460	2022-11-25	U-824		2016-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022128-004	7368460*PED	2023-05-25		Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022128-001	6586430	2019-12-01	U-824	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-001	7576097	2021-05-25		Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-001	6667314	2021-08-06	U-824	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-001	7368460	2022-11-25	U-824			`74a2ff9319b5…`

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	N022128-001	NPP	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-001	NS	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-002	NPP	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-002	NS	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-003	NPP	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-003	NS	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-004	NPP	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022128-004	NS	2019-11-04	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022128-001	NPP	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-001	NS	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-002	NPP	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-002	NS	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-003	NPP	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-003	NS	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-004	NPP	2019-11-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022128-004	NS	2019-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022128-001	NPP	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-001	NS	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-002	NPP	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-002	NS	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-003	NPP	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-003	NS	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-004	NPP	2019-11-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022128-004	NS	2019-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022128-001	NPP	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-001	NS	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-002	NPP	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-002	NS	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-003	NPP	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-003	NS	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-004	NPP	2019-11-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022128-004	NS	2019-11-04	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SELZENTRY	MARAVIROC	A-S Medication Solutions	3c52dddd-0457-41cd-99e0-d30d4fd00ec5	2023-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022128 application number: NDA022128 ndc (product): 50090-6238
SELZENTRY	MARAVIROC	ViiV Healthcare Company	46f30ac5-c96b-429e-976d-8c5ee1c0761b	2022-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022128 application number: NDA022128 ndc (product): 49702-223 ndc (product): 49702-224

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-223	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-224	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-233	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
49702-235	SELZENTRY	maraviroc	ViiV Healthcare Company	NDA	Current
50090-1486	SELZENTRY	maraviroc	A-S Medication Solutions	NDA	Current
50090-6238	SELZENTRY	maraviroc	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65139	SUPPL	2020-11-03
65138	SUPPL	2020-11-03
65128	SUPPL	2020-11-03
54932	SUPPL	2018-07-20
54916	SUPPL	2018-07-19
54915	SUPPL	2018-07-19
50201	SUPPL	2017-10-26
45848	SUPPL	2016-11-08
16999	SUPPL	2015-05-11
29301	SUPPL	2015-04-22
38291	SUPPL	2014-04-01
6946	SUPPL	2014-03-28
38290	SUPPL	2013-02-20
29300	SUPPL	2013-02-19
16998	SUPPL	2013-02-06
29299	SUPPL	2013-02-04
38289	SUPPL	2012-08-22
6945	SUPPL	2012-08-15
38288	SUPPL	2011-10-25
6944	SUPPL	2011-10-25
16997	SUPPL	2010-06-03
6943	SUPPL	2010-06-03
6942	SUPPL	2009-11-27
16996	SUPPL	2009-11-23
6941	SUPPL	2008-11-28
42425	ORIG	2007-10-05
16995	ORIG	2007-08-07
6940	ORIG	2007-08-07