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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022560

ATELVIA (RISEDRONATE SODIUM)
35MG
Marketing Status: Prescription
Active Ingredient: RISEDRONATE SODIUM
Proprietary Name: ATELVIA
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 35MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022560
Product Number: 001
Approval Date: Oct 8, 2010
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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