Details for New Drug Application (NDA): 216229

NDA 216229 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, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal, and Stevens J, and is included in thirty-two 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 216229

Tradename:	DEFERASIROX
Applicant:	Annora Pharma
Ingredient:	deferasirox
Patents:	0

Pharmacology for NDA: 216229

Mechanism of Action

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

Suppliers and Packaging for NDA: 216229

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFERASIROX	deferasirox	GRANULE;ORAL	216229	ANDA	Camber Pharmaceuticals, Inc.	31722-029	31722-029-32	30 PACKET in 1 CARTON (31722-029-32) / 1 GRANULE in 1 PACKET
DEFERASIROX	deferasirox	GRANULE;ORAL	216229	ANDA	Camber Pharmaceuticals, Inc.	31722-030	31722-030-32	30 PACKET in 1 CARTON (31722-030-32) / 1 GRANULE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	180MG
Approval Date:	Sep 22, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	360MG
Approval Date:	Sep 22, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	90MG
Approval Date:	Mar 16, 2023	TE:	AB	RLD:	No

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