Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022283

ZEGERID OTC (OMEPRAZOLE; SODIUM BICARBONATE)
20MG/PACKET;1.68GM/PACKET
Marketing Status: Over-the-counter
Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: ZEGERID OTC
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 20MG/PACKET;1.68GM/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022283
Product Number: 001
Approval Date: Jun 17, 2013
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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