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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 214194

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NDA 214194 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Cipla, Epic Pharma Llc, MSN, Pharmobedient, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Jubilant Generics, Piramal, and Stevens J, and is included in thirty-five NDAs. It is available from twenty suppliers. Additional details are available on the DEFERASIROX profile page.

The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

Summary for 214194

Tradename:	DEFERASIROX
Applicant:	Amneal
Ingredient:	deferasirox
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	180MG
Approval Date:	Feb 9, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	360MG
Approval Date:	Feb 9, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	90MG
Approval Date:	Aug 2, 2021	TE:		RLD:	No

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