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Last Updated: March 28, 2024

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 one supplier. 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 ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.
Summary for 078215
Pharmacology for NDA: 078215
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 ferric oxyhydroxide INJECTABLE;INJECTION 078215 ANDA Hikma Pharmaceuticals USA Inc. 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 ferric oxyhydroxide INJECTABLE;INJECTION 078215 ANDA Hikma Pharmaceuticals USA Inc. 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;INJECTIONStrengthEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Approval Date:Mar 31, 2011TE:ABRLD:No

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