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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202229

ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM)
333MG
Marketing Status: Prescription
Active Ingredient: ACAMPROSATE CALCIUM
Proprietary Name: ACAMPROSATE CALCIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 333MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A202229
Product Number: 001
Approval Date: Jul 16, 2013
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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