U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205545
Company: AJANTA PHARMA LTD
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
07/27/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/06/2020 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/06/2020 SUPPL-1 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 STRIDES PHARMA
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 STRIDES PHARMA
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 021636 SALIX
Back to Top