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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 016267


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NDA 016267 describes DESFERAL, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. 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:Novartis
Ingredient:deferoxamine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016267
Mechanism of ActionIron Chelating Activity
Medical Subject Heading (MeSH) Categories for 016267
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 25, 2000TE:RLD:Yes

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