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Generated: November 13, 2018

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Details for New Drug Application (NDA): 017441

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NDA 017441 describes INFED, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the INFED profile page.

The generic ingredient in INFED 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 017441
Tradename:INFED
Applicant:Allergan Sales Llc
Ingredient:iron dextran
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017441
Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 017441
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INFED iron dextran INJECTABLE;INJECTION 017441 NDA Allergan, Inc. 0023-6082 0023-6082-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0023-6082-10) > 2 mL in 1 VIAL, SINGLE-DOSE
INFED iron dextran INJECTABLE;INJECTION 017441 NDA Actavis Pharma, Inc. 52544-931 52544-931-02 10 VIAL, SINGLE-DOSE in 1 CARTON (52544-931-02) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG IRON/ML
Approval Date:Approved Prior to Jan 1, 1982TE:BPRLD:Yes

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