Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076885
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG 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
11/08/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076885Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76885TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076885Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2019 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/07/2019 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/07/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/07/2019 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/03/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/03/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076885Orig1s000lbl.pdf

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