Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079182
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription AB No No
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/19/2013 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

OMEPRAZOLE AND SODIUM BICARBONATE

FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 205545 AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 079182 PAR PHARM
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 021636 SALIX

FOR SUSPENSION;ORAL; 40MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 205545 AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 079182 PAR PHARM
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 021636 SALIX

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