Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078966
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;1.1GM CAPSULE;ORAL Discontinued None No No
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE;ORAL Discontinued None 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
05/25/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078966s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/27/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/13/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/13/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/13/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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