Last Updated: May 16, 2026

Generic Companies with Tentative Approvals for: tofacitinib

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tofacitinib 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
Dexcel	tofacitinib citrate	218668	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL
Msn Pharms Inc	tofacitinib citrate	217299	10MG	TABLET;ORAL
Apotex Inc	tofacitinib	218096	5MG	TABLET
Biocon Pharma	tofacitinib citrate	219442	EQ 22MG BASE	TABLET, EXTENDED RELEASE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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