Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021636

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ZEGERID (OMEPRAZOLE; SODIUM BICARBONATE)
20MG/PACKET;1.68GM/PACKET
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: ZEGERID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 20MG/PACKET;1.68GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021636
Product Number: 001
Approval Date: Jun 15, 2004
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZEGERID (OMEPRAZOLE; SODIUM BICARBONATE)
40MG/PACKET;1.68GM/PACKET
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE; SODIUM BICARBONATE
Proprietary Name: ZEGERID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 40MG/PACKET;1.68GM/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021636
Product Number: 002
Approval Date: Dec 21, 2004
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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