Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211824


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NDA 211824 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Aurobindo Pharma, Cipla, 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-one suppliers. Additional details are available on the DEFERASIROX profile page.

The generic ingredient in DEFERASIROX is deferasirox. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 211824
Tradename:DEFERASIROX
Applicant:Alembic
Ingredient:deferasirox
Patents:0
Pharmacology for NDA: 211824
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Cytochrome P450 2C8 Inhibitors
Cytochrome P450 3A4 Inducers
Iron Chelating Activity
Suppliers and Packaging for NDA: 211824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFERASIROX deferasirox TABLET;ORAL 211824 ANDA Alembic Pharmaceuticals Limited 46708-410 46708-410-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-410-30)
DEFERASIROX deferasirox TABLET;ORAL 211824 ANDA Alembic Pharmaceuticals Limited 46708-410 46708-410-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-410-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:Nov 20, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength360MG
Approval Date:Nov 20, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength180MG
Approval Date:Jun 15, 2020TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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