Last Updated: August 8, 2026

Details for New Drug Application (NDA): 217298

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NDA 217298 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, Sciegen Pharms, 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-six NDAs. It is available from twenty-one 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-three suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

Summary for 217298

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

Pharmacology for NDA: 217298

Mechanism of Action	Janus Kinase Inhibitors

Suppliers and Packaging for NDA: 217298

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOFACITINIB CITRATE	tofacitinib citrate	SOLUTION;ORAL	217298	ANDA	Novadoz Pharmaceuticals LLC	72205-121	72205-121-81	240 mL in 1 BOTTLE (72205-121-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 1MG BASE/ML
Approval Date:	Jun 3, 2026	TE:	AA	RLD:	No

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