Details for New Drug Application (NDA): 016267

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NDA 016267 describes DESFERAL, which is a drug marketed by Mitem Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the DESFERAL profile page.

The generic ingredient in DESFERAL 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 016267

Tradename:	DESFERAL
Applicant:	Mitem Pharma
Ingredient:	deferoxamine mesylate
Patents:	0

Pharmacology for NDA: 016267

Mechanism of Action	Iron Chelating Activity

Medical Subject Heading (MeSH) Categories for 016267

Siderophores

Suppliers and Packaging for NDA: 016267

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESFERAL	deferoxamine mesylate	INJECTABLE;INJECTION	016267	NDA	Novartis Pharmaceuticals Corporation	0078-0467	0078-0467-91	4 VIAL in 1 CARTON (0078-0467-91) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0078-0467-61)
DESFERAL	deferoxamine mesylate	INJECTABLE;INJECTION	016267	NDA	MITEM PHARMA	87081-467	87081-467-91	4 mL in 1 VIAL (87081-467-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 25, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 016267

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mitem Pharma	DESFERAL	deferoxamine mesylate	INJECTABLE;INJECTION	016267-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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