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Details for New Drug Application (NDA): 078718

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NDA 078718 describes DEFEROXAMINE MESYLATE, which is a drug marketed by Watson Labs, Fresenius Kabi Usa, Hospira, and West-ward Pharms Int, and is included in four NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.

Summary for NDA: 078718

Tradename:
DEFEROXAMINE MESYLATE
Applicant:
Fresenius Kabi Usa
Ingredient:
deferoxamine mesylate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078718

Mechanism of ActionIron Chelating Activity

Suppliers and Packaging for NDA: 078718

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEFEROXAMINE MESYLATE
deferoxamine mesylate
INJECTABLE;INJECTION 078718 ANDA APP Pharmaceuticals, LLC 63323-597 63323-597-10 1 VIAL in 1 BOX (63323-597-10) > 5.3 mL in 1 VIAL
DEFEROXAMINE MESYLATE
deferoxamine mesylate
INJECTABLE;INJECTION 078718 ANDA APP Pharmaceuticals, LLC 63323-599 63323-599-30 1 VIAL in 1 BOX (63323-599-30) > 21.1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Sep 15, 2009TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/VIAL
Approval Date:Sep 15, 2009TE:APRLD:No


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