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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 214264

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NDA 214264 describes TOFACITINIB, which is a drug marketed by Aurobindo Pharma Ltd, Zydus Pharms, Hikma, Ajanta Pharma Ltd, and Micro Labs, and is included in six NDAs. Additional details are available on the TOFACITINIB profile page.

The generic ingredient in TOFACITINIB 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 214264

Tradename:	TOFACITINIB
Applicant:	Zydus Pharms
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:	Aug 19, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 22MG BASE
Approval Date:	Aug 19, 2021	TE:		RLD:	No

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