Last Updated: September 28, 2026

Details for New Drug Application (NDA): 217115

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NDA 217115 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, Macleods Pharms, Mankind Pharma, Micro Labs, Ne Rx Pharma, Ph Health, Pharmobedient, Piramal, Regcon Holdings, Rhodes Pharms, Shilpa, Somerset Theraps Llc, Umedica, Viwit Pharm, and Zydus, and is included in twenty-two NDAs. It is available from twenty-eight suppliers. Additional details are available on the VARENICLINE TARTRATE profile page.

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

Summary for 217115

Tradename:	VARENICLINE TARTRATE
Applicant:	Piramal
Ingredient:	varenicline tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 217115

Nicotinic Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Jul 23, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jul 23, 2024	TE:	AB	RLD:	No

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