MedPath
FDA Approval

Deferoxamine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 22, 2020
Labeling Type
Human Prescription Drug Label
Deferoxamine(95 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC

840771732

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Deferoxamine

Product Details

NDC Product Code
63323-597
Application Number
ANDA078718
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective Date
May 16, 2017
Code: V9TKO7EO6KClass: ACTIBQuantity: 95 mg in 1 mL

Deferoxamine

Product Details

NDC Product Code
63323-599
Application Number
ANDA078718
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective Date
May 16, 2017
Code: V9TKO7EO6KClass: ACTIBQuantity: 95 mg in 1 mL
© Copyright 2025. All Rights Reserved by MedPath