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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204923

OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE; SODIUM BICARBONATE)
20MG;1.1GM
Marketing Status: Over-the-counter
Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: OMEPRAZOLE AND SODIUM BICARBONATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG;1.1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204923
Product Number: 001
Approval Date: Nov 7, 2016
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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