Last Updated: May 10, 2026

Details for New Drug Application (NDA): 213268

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NDA 213268 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, Umedica, Viwit Pharm, and Zydus, and is included in twenty-one NDAs. It is available from twenty-nine 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-three suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

Summary for 213268

Tradename:	VARENICLINE TARTRATE
Applicant:	Rhodes Pharms
Ingredient:	varenicline tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 213268

Nicotinic Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	May 21, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	May 21, 2025	TE:		RLD:	No

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