Details for New Drug Application (NDA): 211824

NDA 211824 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Norvium Bioscience, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal, and Stevens J, and is included in thirty-three 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 211824

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

Pharmacology for NDA: 211824

Mechanism of Action

Cytochrome 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:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Nov 20, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	360MG
Approval Date:	Nov 20, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	180MG
Approval Date:	Jun 15, 2020	TE:	AB	RLD:	No

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