Application 217115

Type: ANDA
Sponsor: PIRAMAL

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217115-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2024-07-23
A217115-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217115-001	AB
A217115-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL		2024-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL		2024-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL		2024-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`a50c72e98297…`

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	A217115-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217115-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217115-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217115-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217115-002	AB	1	`011fe1cb6892…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217115-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217115-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-002	AB	1	`a50c72e98297…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
varenicline	VARENICLINE TARTRATE	A-S Medication Solutions	2d5dfa6e-e69d-414a-8ff2-44714debbbe2	2024-04-29	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
varenicline	VARENICLINE TARTRATE	Major Pharmaceuticals	1297c291-da28-4a73-9c28-d5adee36d7b7	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
Varenicline	VARENICLINE TARTRATE	Camber Pharmaceuticals, Inc.	7bd1abc8-2689-496b-b3f2-1cefe218ff5a	2023-11-08	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	0fefd790-b526-4f2f-8c83-5f39f7306556	2020-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	f22e3aef-714b-4014-8d77-83ee03fd1f57	2020-01-01	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
CHANTIX	VARENICLINE TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b4403cea-6300-4d89-8fde-5149a80b08b9	2017-12-18	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.