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Generated: May 27, 2019

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Details for New Drug Application (NDA): 020955

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NDA 020955 describes FERRLECIT, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the FERRLECIT profile page.

The generic ingredient in FERRLECIT is sodium ferric gluconate complex. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium ferric gluconate complex profile page.
Summary for 020955
Tradename:FERRLECIT
Applicant:Sanofi Aventis Us
Ingredient:sodium ferric gluconate complex
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020955
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 020955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FERRLECIT sodium ferric gluconate complex INJECTABLE;INJECTION 020955 NDA sanofi-aventis U.S. LLC 0024-2792 0024-2792-10 10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) > 5 mL in 1 VIAL, SINGLE-USE
FERRLECIT sodium ferric gluconate complex INJECTABLE;INJECTION 020955 NDA sanofi-aventis U.S. LLC 0024-2794 0024-2794-10 10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) > 5 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength62.5MG/5ML
Approval Date:Feb 18, 1999TE:ABRLD:Yes

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