Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209400

OMEPRAZOLE (OMEPRAZOLE)
20MG
Marketing Status: Over-the-counter
Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209400
Product Number: 001
Approval Date: Jul 5, 2017
Applicant Holder Full Name: DEXCEL PHARMA TECHNOLOGIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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