Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205545

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OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE; SODIUM BICARBONATE)
20MG/PACKET;1.68GM/PACKET
Marketing Status: Prescription

Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: OMEPRAZOLE AND SODIUM BICARBONATE
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 20MG/PACKET;1.68GM/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205545
Product Number: 001
Approval Date: Jul 27, 2016
Applicant Holder Full Name: AJANTA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE; SODIUM BICARBONATE)
40MG/PACKET;1.68GM/PACKET
Marketing Status: Prescription

Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: OMEPRAZOLE AND SODIUM BICARBONATE
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 40MG/PACKET;1.68GM/PACKET
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A205545
Product Number: 002
Approval Date: Jul 27, 2016
Applicant Holder Full Name: AJANTA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information