Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204068

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OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE; SODIUM BICARBONATE)
20MG;1.1GM
Marketing Status: Prescription

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: AB
Application Number: A204068
Product Number: 001
Approval Date: Jul 15, 2016
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE; SODIUM BICARBONATE)
40MG;1.1GM
Marketing Status: Prescription

Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: OMEPRAZOLE AND SODIUM BICARBONATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG;1.1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204068
Product Number: 002
Approval Date: Jul 15, 2016
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information