Last Updated: July 21, 2026

Generic Companies with Tentative Approvals for: tofacitinib citrate

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tofacitinib citrate 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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Applicant	Generic Name	NDA	Strength	Dosage Form
Sinotherapeutics Inc	tofacitinib citrate	216001	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL
Biocon Pharma	tofacitinib citrate	219442	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL
Dexcel	tofacitinib citrate	218668	22MG	TABLET, EXTENDED RELEASE;ORAL
Micro Labs	tofacitinib citrate	209738	EQ 5MG BASE	TABLET;ORAL
Biocon Pharma	tofacitinib citrate	219442	EQ 22MG BASE	TABLET, EXTENDED RELEASE;ORAL
Specgx Llc	tofacitinib citrate	219395	5MG	TABLET
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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