Details for New Drug Application (NDA): 210519

NDA 210519 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 210519

Tradename:	DEFERASIROX
Applicant:	Alkem Labs Ltd
Ingredient:	deferasirox
Patents:	0

Pharmacology for NDA: 210519

Mechanism of Action

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

Suppliers and Packaging for NDA: 210519

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	210519	ANDA	Ascend Laboratories, LLC	67877-549	67877-549-30	30 TABLET, FOR SUSPENSION in 1 BOTTLE (67877-549-30)
DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	210519	ANDA	Ascend Laboratories, LLC	67877-550	67877-550-30	30 TABLET, FOR SUSPENSION in 1 BOTTLE (67877-550-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	125MG
Approval Date:	Nov 20, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	250MG
Approval Date:	Nov 20, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	500MG
Approval Date:	Nov 20, 2019	TE:	AB	RLD:	No

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