Last Updated: July 26, 2026

Details for New Drug Application (NDA): 219370

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NDA 219370 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 219370

Tradename:	TOFACITINIB CITRATE
Applicant:	Auson
Ingredient:	tofacitinib citrate
Patents:	0

Pharmacology for NDA: 219370

Mechanism of Action	Janus Kinase Inhibitors

Suppliers and Packaging for NDA: 219370

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOFACITINIB CITRATE	tofacitinib citrate	SOLUTION;ORAL	219370	ANDA	IPG Pharmaceuticals, Inc	71085-099	71085-099-24	1 BOTTLE in 1 CARTON (71085-099-24) / 240 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 1MG BASE/ML
Approval Date:	Jun 9, 2026	TE:	AA	RLD:	No

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