Last Updated: September 28, 2026

Details for New Drug Application (NDA): 218900

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NDA 218900 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, Micro Labs, Somerset Theraps Llc, Specgx Llc, and Yaopharma Co Ltd, and is included in twenty-six NDAs. It is available from twenty-two suppliers. Additional details are available on the TOFACITINIB CITRATE profile page.

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

Summary for 218900

Tradename:	TOFACITINIB CITRATE
Applicant:	Saptalis Pharms
Ingredient:	tofacitinib citrate
Patents:	0

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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