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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205332

IBANDRONATE SODIUM (IBANDRONATE SODIUM)
EQ 3MG BASE/3ML
Marketing Status: Prescription
Active Ingredient: IBANDRONATE SODIUM
Proprietary Name: IBANDRONATE SODIUM
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 3MG BASE/3ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205332
Product Number: 001
Approval Date: Aug 19, 2015
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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