Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077056
Company: TEVA
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
08/02/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077056ltrTA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2015 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/05/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/05/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

05/03/2013 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

10/03/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/03/2012 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/31/2011 SUPPL-7 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/31/2011 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/31/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/21/2009 SUPPL-3 Labeling

Label is not available on this site.

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