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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090901
Company: JUBILANT GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Discontinued None No No
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE;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
08/30/2011 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
02/04/2020 SUPPL-22 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/04/2020 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/04/2020 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/07/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/16/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/16/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/16/2012 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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