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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218668

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NDA 218668 describes TOFACITINIB CITRATE, which is a drug marketed by Hikma, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dexcel, Sinotherapeutics Inc, Zydus Pharms, and Micro Labs, and is included in nine NDAs. 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. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

Summary for 218668

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 11MG BASE
Approval Date:	Dec 16, 2024	TE:		RLD:	No

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