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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214341


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NDA 214341 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 214341
Tradename:DEFERASIROX
Applicant:Annora Pharma
Ingredient:deferasirox
Patents:0
Pharmacology for NDA: 214341
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Cytochrome P450 2C8 Inhibitors
Cytochrome P450 3A4 Inducers
Iron Chelating Activity
Suppliers and Packaging for NDA: 214341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFERASIROX deferasirox TABLET;ORAL 214341 ANDA Camber Pharmaceuticals, Inc. 31722-011 31722-011-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-011-30)
DEFERASIROX deferasirox TABLET;ORAL 214341 ANDA Camber Pharmaceuticals, Inc. 31722-012 31722-012-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-012-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:May 14, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength180MG
Approval Date:May 14, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength360MG
Approval Date:May 14, 2021TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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