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Generated: November 15, 2018

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Details for New Drug Application (NDA): 078215

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NDA 078215 describes SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, which is a drug marketed by West-ward Pharms Int and is included in one NDA. It is available from three suppliers. Additional details are available on the SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE profile page.

The generic ingredient in SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE is sodium ferric gluconate complex. There are one thousand four hundred and fifty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium ferric gluconate complex profile page.
Summary for 078215
Tradename:SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
Applicant:West-ward Pharms Int
Ingredient:sodium ferric gluconate complex
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078215
Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 078215
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE sodium ferric gluconate complex INJECTABLE;INJECTION 078215 ANDA West-Ward Pharmaceuticals Corp 0143-9298 0143-9298-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE sodium ferric gluconate complex INJECTABLE;INJECTION 078215 ANDA West-Ward Pharmaceutical Corp 0143-9570 0143-9570-10 10 VIAL in 1 CARTON (0143-9570-10) > 5 mL in 1 VIAL (0143-9570-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength62.5MG/5ML
Approval Date:Mar 31, 2011TE:ABRLD:No

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