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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212879

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NDA 212879 describes VARENICLINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Dr Reddys, Hetero Labs Ltd Iii, Kanchan Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Ne Rx Pharma, Ph Health, Pharmobedient, Piramal, Regcon Holdings, Rhodes Pharms, Shilpa, Viwit Pharm, and Zydus, and is included in twenty NDAs. It is available from twenty-six suppliers. Additional details are available on the VARENICLINE TARTRATE profile page.

The generic ingredient in VARENICLINE TARTRATE is varenicline tartrate. There are twelve drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

Summary for 212879

Tradename:	VARENICLINE TARTRATE
Applicant:	Viwit Pharm
Ingredient:	varenicline tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 212879

Nicotinic Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	May 6, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	May 6, 2025	TE:	AB	RLD:	No

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