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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214512

ALENDRONATE SODIUM (ALENDRONATE SODIUM)
EQ 70MG BASE/75ML
Marketing Status: Prescription
Active Ingredient: ALENDRONATE SODIUM
Proprietary Name: ALENDRONATE SODIUM
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 70MG BASE/75ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A214512
Product Number: 001
Approval Date: May 11, 2023
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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