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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 215931

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NDA 215931 describes VARENICLINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Bionpharma, Dr Reddys, Endo Operations, Hetero Labs Ltd Iii, Indoco, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Piramal, and Zydus, and is included in fourteen NDAs. It is available from twenty-two 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. Twenty-six suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

Summary for 215931

Tradename:	VARENICLINE TARTRATE
Applicant:	Dr Reddys
Ingredient:	varenicline tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 215931

Nicotinic Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Oct 1, 2024	TE:	AB	RLD:	No

Profile for product number 002

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

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