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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209738

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NDA 209738 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 209738

Tradename:	TOFACITINIB CITRATE
Applicant:	Micro Labs
Ingredient:	tofacitinib citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Mar 13, 2023	TE:		RLD:	No

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