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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078215

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (FERRIC OXYHYDROXIDE)
EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Marketing Status: Prescription
Active Ingredient: FERRIC OXYHYDROXIDE
Proprietary Name: SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078215
Product Number: 001
Approval Date: Mar 31, 2011
Applicant Holder Full Name: WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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