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Generated: November 19, 2018

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Details for New Drug Application (NDA): 040024

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NDA 040024 describes DEXFERRUM, which is a drug marketed by Luitpold and is included in one NDA. It is available from one supplier. Additional details are available on the DEXFERRUM profile page.

The generic ingredient in DEXFERRUM is iron dextran. There are eighty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the iron dextran profile page.
Summary for 040024
Tradename:DEXFERRUM
Applicant:Luitpold
Ingredient:iron dextran
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040024
Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 040024
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXFERRUM iron dextran INJECTABLE;INJECTION 040024 NDA American Regent, Inc. 0517-0134 0517-0134-10 10 VIAL, SINGLE-DOSE in 1 BOX (0517-0134-10) > 1 mL in 1 VIAL, SINGLE-DOSE
DEXFERRUM iron dextran INJECTABLE;INJECTION 040024 NDA American Regent, Inc. 0517-0234 0517-0234-10 10 VIAL, SINGLE-DOSE in 1 BOX (0517-0234-10) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG IRON/ML
Approval Date:Feb 23, 1996TE:BPRLD:No

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