Application 202019

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202019-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL			2024-02-28
A202019-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202019-002	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
2026-08-18 06:07:40	2026-07	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-02-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202019-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202019-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202019-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202019-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202019-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202019-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202019-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202019-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202019-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-002	AB	1	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202019-002	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 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VARENICLINE	VARENICLINE	Umedica Laboratories USA Inc.	f2e57493-d099-4055-8e92-67611c8d20f4	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: VARENICLINE generic name: VARENICLINE
VARENICLINE	VARENICLINE	A-S Medication Solutions	8a06d177-0e62-457d-b0c8-47f60a313a1c	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: VARENICLINE generic name: VARENICLINE
Varenicline	VARENICLINE TARTRATE	Ajanta Pharma USA Inc.	2f86bb7b-c6a6-4915-8ba1-17251540971c	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Varenicline
Varenicline	VARENICLINE TARTRATE	REMEDYREPACK INC.	d759167f-e0b2-46d5-a34a-3c8858e39590	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Varenicline
Varenicline	VARENICLINE TARTRATE	Marlex Pharmaceuticals, Inc.	29b6b4ca-aeef-1295-e063-6394a90a21b9	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Varenicline
Varenicline	VARENICLINE TARTRATE	Par Health USA, LLC	9e5c0ef3-3179-4d7b-bc76-901473c73ce8	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Varenicline
varenicline	VARENICLINE TARTRATE	AvKARE	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: varenicline
Varenicline	VARENICLINE TARTRATE	American Health Packaging	16a03b5e-03e0-4b0b-92a4-aaf0669906f7	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Varenicline
Varenicline	VARENICLINE TARTRATE	American Health Packaging	38be1217-cd55-416a-bf4b-6ede6bfd3727	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Varenicline
VARENICLINE TARTRATE	VARENICLINE TARTRATE	Lupin Pharmaceuticals, Inc.	bf20c4cc-1731-4873-8de1-b93d17591e9f	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: VARENICLINE generic name: VARENICLINE
Varenicline	VARENICLINE	Macleods Pharmaceuticals Limited	c325d582-8f43-40ea-b348-87837de97a07	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Varenicline generic name: VARENICLINE
varenicline	VARENICLINE	Nivagen Pharmaceuticals Inc.	077ec752-4145-4592-9ee1-6fdc9a04795a	2025-08-31	Warnings, Adverse reactions	Name fallback brand name: varenicline generic name: VARENICLINE
VARENICLINE	VARENICLINE	Golden State Medical Supply, Inc.	fa5a2672-2378-c27f-e053-6294a90aba65	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: VARENICLINE generic name: VARENICLINE
Varenicline	VARENICLINE	Aurobindo Pharma Limited	0004a0bb-87c0-46f8-b36a-95c98107395d	2025-05-08	Warnings, Adverse reactions	Name fallback brand name: Varenicline generic name: VARENICLINE
VARENICLINE	VARENICLINE	Apotex Corp	78d1857f-8708-5410-792f-4a3e5e7971a5	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: VARENICLINE generic name: VARENICLINE
Varenicline	VARENICLINE TARTRATE	Florida Pharmaceutical Products, LLC	2b9c8b1e-6193-4d8e-9b50-6aca27294263	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: Varenicline
Varenicline tartrate	VARENICLINE TARTRATE	Indoco Remedies Limited	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Varenicline
Varenicline	VARENICLINE TARTRATE	NorthStar RxLLC	9031aa0d-2f68-4b9d-903f-ac0e95cbf35f	2024-09-27	Warnings, Adverse reactions	Name fallback brand name: Varenicline
VARENICLINE	VARENICLINE	Bryant Ranch Prepack	dc0d2c60-b197-4bbf-a3fd-78e0f5a21440	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: VARENICLINE generic name: VARENICLINE
varenicline	VARENICLINE TARTRATE	A-S Medication Solutions	6351047a-9896-4a30-8e49-4d306ce9c9c0	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: varenicline