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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214559


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NDA 214559 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 214559
Tradename:DEFERASIROX
Applicant:Epic Pharma Llc
Ingredient:deferasirox
Patents:0
Pharmacology for NDA: 214559
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Cytochrome P450 2C8 Inhibitors
Cytochrome P450 3A4 Inducers
Iron Chelating Activity
Suppliers and Packaging for NDA: 214559
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFERASIROX deferasirox GRANULE;ORAL 214559 ANDA EPIC PHARMA, LLC 42806-371 42806-371-30 30 PACKET in 1 CARTON (42806-371-30) / 1 GRANULE in 1 PACKET
DEFERASIROX deferasirox GRANULE;ORAL 214559 ANDA EPIC PHARMA, LLC 42806-372 42806-372-30 30 PACKET in 1 CARTON (42806-372-30) / 1 GRANULE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength90MG
Approval Date:Mar 9, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength180MG
Approval Date:Mar 9, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength360MG
Approval Date:Mar 9, 2021TE:ABRLD:No

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Preferred Citation:

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