Details for New Drug Application (NDA): 210727

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NDA 210727 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 nineteen 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 suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFERASIROX	deferasirox	TABLET;ORAL	210727	ANDA	Amneal Pharmaceuticals NY LLC	69238-1486	69238-1486-3	30 TABLET, FILM COATED in 1 BOTTLE (69238-1486-3)
DEFERASIROX	deferasirox	TABLET;ORAL	210727	ANDA	Amneal Pharmaceuticals NY LLC	69238-1487	69238-1487-3	30 TABLET, FILM COATED in 1 BOTTLE (69238-1487-3)

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Dec 27, 2019	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	360MG
Approval Date:	Dec 27, 2019	TE:		RLD:	No

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

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