Application 021928

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHANTIX	VARENICLINE TARTRATE	TABLET;ORAL	EQ 0.5MG BASE	Yes	No
002	CHANTIX	VARENICLINE TARTRATE	TABLET;ORAL	EQ 1MG BASE	Yes	Yes

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
N021928-001	CHANTIX	VARENICLINE TARTRATE	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10
N021928-002	CHANTIX	VARENICLINE TARTRATE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021928-001	AB
N021928-002	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 3 · 82 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UTC	2026-02	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	CHANTIX	EQ 0.5MG BASE	TABLET / ORAL		RLD	2006-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	CHANTIX	EQ 1MG BASE	TABLET / ORAL		RLD	2006-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021928-001	CHANTIX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	CHANTIX	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2006-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021928-001	CHANTIX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	CHANTIX	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2006-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021928-001	CHANTIX	EQ 0.5MG BASE	TABLET / ORAL		RLD	2006-05-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	CHANTIX	EQ 1MG BASE	TABLET / ORAL		RLD, RS	2006-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021928-001	CHANTIX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-002	CHANTIX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021928-001	CHANTIX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021928-002	CHANTIX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021928-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021928-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021928-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021928-002	AB	1	`31067a03dcf5…`
2022-04-08 23:34 UTC	2022-04	N021928-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021928-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021928-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021928-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021928-002	AB	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021928-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021928-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	6890927	2022-05-06	U-56	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	7265119	2022-08-03	U-56	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	6890927*PED	2022-11-06		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	7265119*PED	2023-02-03		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	6890927	2022-05-06	U-56	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	7265119	2022-08-03	U-56	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	6890927*PED	2022-11-06		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	7265119*PED	2023-02-03		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021928-001	6890927	2022-05-06	U-56	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-001	7265119	2022-08-03	U-56	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-001	6890927*PED	2022-11-06		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-001	7265119*PED	2023-02-03		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	6890927	2022-05-06	U-56	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	7265119	2022-08-03	U-56	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	6890927*PED	2022-11-06		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	7265119*PED	2023-02-03		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021928-001	6890927	2022-05-06	U-56	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-001	7265119	2022-08-03	U-56	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-001	6890927*PED	2022-11-06		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-001	7265119*PED	2023-02-03		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	6890927	2022-05-06	U-56	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	7265119	2022-08-03	U-56	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	6890927*PED	2022-11-06		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	7265119*PED	2023-02-03		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021928-001	6410550	2020-05-10	U-56	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	6410550*PED	2020-11-10		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	6890927	2022-05-06	U-56	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	7265119	2022-08-03	U-56	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	6890927*PED	2022-11-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	7265119*PED	2023-02-03		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	6410550	2020-05-10	U-56	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	6410550*PED	2020-11-10		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	6890927	2022-05-06	U-56	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	7265119	2022-08-03	U-56	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	6890927*PED	2022-11-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	7265119*PED	2023-02-03		Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021928-001	6890927	2022-05-06	U-56	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-001	7265119	2022-08-03	U-56	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-001	6890927*PED	2022-11-06		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-001	7265119*PED	2023-02-03		Pediatric extension	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	M-237	2022-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-001	PED	2022-08-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	M-237	2022-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021928-002	PED	2022-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021928-001	M-237	2022-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-001	PED	2022-08-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	M-237	2022-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021928-002	PED	2022-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021928-001	M-237	2022-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-001	PED	2022-08-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	M-237	2022-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021928-002	PED	2022-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021928-001	M-183	2019-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	M-192	2019-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	PED	2020-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	PED	2020-06-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	M-237	2022-02-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-001	PED	2022-08-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	M-183	2019-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	M-192	2019-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	PED	2020-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	PED	2020-06-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	M-237	2022-02-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021928-002	PED	2022-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021928-001	M-237	2022-02-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-001	PED	2022-08-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-002	M-237	2022-02-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021928-002	PED	2022-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021928-001	M-237	2022-02-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021928-001	PED	2022-08-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021928-002	M-237	2022-02-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021928-002	PED	2022-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021928-001	M-237	2022-02-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021928-001	PED	2022-08-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021928-002	M-237	2022-02-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021928-002	PED	2022-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021928-001	M-237	2022-02-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021928-001	PED	2022-08-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021928-002	M-237	2022-02-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021928-002	PED	2022-08-22	`5aa47cf7b7d7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHANTIX	VARENICLINE TARTRATE	Pfizer Laboratories Div Pfizer Inc	f0ff4f27-5185-4881-a749-c6b7a0ca5696	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928 ndc (product): 0069-0471 ndc (product): 0069-0468 ndc (product): 0069-0469
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	0fefd790-b526-4f2f-8c83-5f39f7306556	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928 ndc (product): 63187-618
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	f22e3aef-714b-4014-8d77-83ee03fd1f57	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928 ndc (product): 71205-381
CHANTIX	VARENICLINE TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b4403cea-6300-4d89-8fde-5149a80b08b9	2017-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928 ndc (product): 43353-899

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0468	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0468	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0468	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0468	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0468	CHANTIX	varenicline tartrate	Pfizer Labs, Division of Pfizer Inc.	NDA	Current
0069-0468	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0469	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0469	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0469	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0469	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0469	CHANTIX	varenicline tartrate	Pfizer Labs, Division of Pfizer Inc.	NDA	Current
0069-0469	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0471	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0471	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0471	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0471	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0471	CHANTIX	varenicline tartrate	Pfizer Labs, Division of Pfizer Inc.	NDA	Current
0069-0471	CHANTIX	varenicline tartrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
21695-633	Chantix	varenicline tartrate	Rebel Distributors Corp	NDA	Current
21695-945	CHANTIX	varenicline tartrate	Rebel Distributors Corp	NDA	Current
21695-946	Chantix	varenicline tartrate	Rebel Distributors Corp	NDA	Current
43353-899	CHANTIX	varenicline tartrate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-0995	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-0995	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-0998	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-0998	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-3528	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-4481	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-4481	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
50090-4482	CHANTIX	varenicline tartrate	A-S Medication Solutions	NDA	Current
63187-618	CHANTIX	varenicline tartrate	Proficient Rx LP	NDA	Current
63187-618	CHANTIX	varenicline tartrate	Proficient Rx LP	NDA	Current
63187-618	CHANTIX	varenicline tartrate	Proficient Rx LP	NDA	Current
63539-473	CHANTIX	varenicline tartrate	U.S. Pharmaceuticals	NDA	Current
63539-473	CHANTIX	varenicline tartrate	U.S. Pharmaceuticals	NDA	Current
63539-473	CHANTIX	varenicline tartrate	U.S. Pharmaceuticals	NDA	Current
63539-473	CHANTIX	varenicline tartrate	U.S. Pharmaceuticals	NDA	Current
63539-473	CHANTIX	varenicline tartrate	U.S. Pharmaceuticals	NDA	Current
68151-4952	CHANTIX	varenicline tartrate	Carilion Materials Management	NDA	Current
68151-4953	CHANTIX	varenicline tartrate	Carilion Materials Management	NDA	Current
69189-0492	CHANTIX	varenicline tartrate	Avera McKennan Hospital	NDA	Current
71205-381	CHANTIX	varenicline tartrate	Proficient Rx LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82879	SUPPL	2025-07-16
82878	SUPPL	2025-07-15
82877	SUPPL	2025-07-15
65822	SUPPL	2021-01-06
65819	SUPPL	2021-01-06
65818	SUPPL	2021-01-06
65817	SUPPL	2021-01-06
65816	SUPPL	2021-01-06
64839	SUPPL	2020-10-06
64838	SUPPL	2020-10-06
64837	SUPPL	2020-10-06
64836	SUPPL	2020-10-06
64835	SUPPL	2020-10-06
64834	SUPPL	2020-10-06
64832	SUPPL	2020-10-06
57789	SUPPL	2019-02-22
57753	SUPPL	2019-02-22
57752	SUPPL	2019-02-22
54428	SUPPL	2018-06-04
54427	SUPPL	2018-06-04
54416	SUPPL	2018-06-01
54415	SUPPL	2018-06-01
50094	SUPPL	2017-10-18
50091	SUPPL	2017-10-18
46450	SUPPL	2016-12-21
46266	SUPPL	2016-12-20
45079	SUPPL	2016-08-17
45078	SUPPL	2016-08-17
45127	SUPPL	2016-08-12
45126	SUPPL	2016-08-12
37902	SUPPL	2014-10-16
28872	SUPPL	2014-10-16
16597	SUPPL	2014-10-16
16596	SUPPL	2014-10-16
6483	SUPPL	2014-10-16
6481	SUPPL	2014-10-16
28871	SUPPL	2014-09-24
6484	SUPPL	2014-09-24
6482	SUPPL	2014-09-24
37903	SUPPL	2014-09-22
37901	SUPPL	2014-09-22
16595	SUPPL	2014-09-22
28869	SUPPL	2013-03-15
16593	SUPPL	2013-02-21
28870	SUPPL	2012-12-13
16594	SUPPL	2012-12-13
6480	SUPPL	2012-01-25
16592	SUPPL	2012-01-24
28868	SUPPL	2011-11-14
37900	SUPPL	2011-11-10
37899	SUPPL	2011-07-22
37898	SUPPL	2011-07-22
28866	SUPPL	2011-07-22
28865	SUPPL	2011-07-22
16590	SUPPL	2011-07-22
6478	SUPPL	2011-07-22
6479	SUPPL	2011-07-06
28864	SUPPL	2011-02-24
28867	SUPPL	2010-12-22
16591	SUPPL	2010-12-22
37897	SUPPL	2010-05-03
37896	SUPPL	2010-05-03
6477	SUPPL	2010-04-27
6475	SUPPL	2010-04-27
6476	SUPPL	2010-02-17
6474	SUPPL	2009-11-25
6472	SUPPL	2009-11-24
37894	SUPPL	2009-10-21
37895	SUPPL	2009-07-09
16589	SUPPL	2009-07-09
6473	SUPPL	2009-07-08
6471	SUPPL	2008-05-21
16588	SUPPL	2008-05-16
28863	SUPPL	2008-02-04
16587	SUPPL	2008-02-01
37893	SUPPL	2007-11-26
28862	SUPPL	2007-11-26
23685	ORIG	2006-09-01
21874	ORIG	2006-06-16
16586	ORIG	2006-05-16
6470	ORIG	2006-05-16
53437	ORIG	1900-01-01