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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 216615

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NDA 216615 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-eight 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-two suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

Summary for 216615

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

Medical Subject Heading (MeSH) Categories for 216615

Nicotinic Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Apr 8, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Apr 8, 2025	TE:	AB	RLD:	No

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