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Last Updated: January 13, 2026

Generic Companies with Tentative Approvals for: varenicline

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varenicline Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Glossary

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Applicant	Generic Name	NDA	Strength	Dosage Form
Teva Pharms Usa	varenicline	201920	0.5MG	TABLET; ORAL
Watson Labs Inc	varenicline tartrate	201808	EQ 1MG BASE	TABLET;ORAL
Teva Pharms Usa	varenicline	201920	1MG	TABLET; ORAL
Watson Labs Inc	varenicline tartrate	201808	EQ 0.5MG BASE	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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