Last Updated: July 26, 2026

Details for New Drug Application (NDA): 219395

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NDA 219395 describes TOFACITINIB CITRATE, which is a drug marketed by Auson, Hikma, MSN, Saptalis Pharms, Sun Pharm Inds Inc, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Orient Pharma, Sinotherapeutics Inc, Zydus Pharms, Breckenridge, Concord Biotech Ltd, Macleods Pharms Ltd, Micro Labs, Somerset Theraps Llc, Specgx Llc, and Yaopharma Co Ltd, and is included in twenty-five NDAs. It is available from nineteen suppliers. Additional details are available on the TOFACITINIB CITRATE profile page.

The generic ingredient in TOFACITINIB CITRATE is tofacitinib citrate. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

Summary for 219395

Tradename:	TOFACITINIB CITRATE
Applicant:	Specgx Llc
Ingredient:	tofacitinib citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 3, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 3, 2026	TE:	AB	RLD:	No

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