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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 078718

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NDA 078718 describes DEFEROXAMINE MESYLATE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, and West-ward Pharms Int, and is included in five NDAs. It is available from five 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 078718
Applicant:Fresenius Kabi Usa
Ingredient:deferoxamine mesylate
Formulation / Manufacturing:see details
Pharmacology for NDA: 078718
Mechanism of ActionIron Chelating Activity
Medical Subject Heading (MeSH) Categories for 078718
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 Fresenius Kabi USA, 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 Fresenius Kabi USA, LLC 63323-599 63323-599-30 1 VIAL in 1 BOX (63323-599-30) / 21.1 mL in 1 VIAL

Profile for product number 001

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

Profile for product number 002

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

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