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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 209433


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NDA 209433 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 are twenty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 209433
Tradename:DEFERASIROX
Applicant:Glenmark Speclt
Ingredient:deferasirox
Patents:0
Pharmacology for NDA: 209433
Mechanism of ActionCytochrome P450 1A2 Inhibitors
Cytochrome P450 2C8 Inhibitors
Cytochrome P450 3A4 Inducers
Iron Chelating Activity
Suppliers and Packaging for NDA: 209433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 209433 ANDA Glenmark Pharmaceuticals Inc., USA 68462-494 68462-494-90 90 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-90)
DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 209433 ANDA Glenmark Pharmaceuticals Inc., USA 68462-495 68462-495-90 90 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-495-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength125MG
Approval Date:Jan 6, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength250MG
Approval Date:Jan 6, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength500MG
Approval Date:Jan 6, 2020TE:ABRLD:No

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Preferred Citation:

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