Details for New Drug Application (NDA): 207384

NDA 207384 describes DEFEROXAMINE MESYLATE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, and Hospira, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DEFEROXAMINE MESYLATE profile page.

The generic ingredient in DEFEROXAMINE MESYLATE is deferoxamine mesylate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.

Summary for 207384

Tradename:	DEFEROXAMINE MESYLATE
Applicant:	Gland
Ingredient:	deferoxamine mesylate
Patents:	0

Pharmacology for NDA: 207384

Mechanism of Action

Iron Chelating Activity

Medical Subject Heading (MeSH) Categories for 207384

Siderophores

Suppliers and Packaging for NDA: 207384

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	207384	ANDA	Apotex Corp.	60505-6236	60505-6236-6	4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6236-6)
DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	207384	ANDA	Apotex Corp.	60505-6237	60505-6237-6	4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6237-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Sep 29, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2GM/VIAL
Approval Date:	Sep 29, 2017	TE:	AP	RLD:	No

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