Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020528
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAVIK TRANDOLAPRIL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MAVIK TRANDOLAPRIL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MAVIK TRANDOLAPRIL 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
04/26/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020528Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020528s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020528Orig1s025ltr.pdf
01/29/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020528Orig1s024ltr.pdf
12/24/2014 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020528s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020528Orig1s023ltr.pdf
06/13/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/11/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528Orig1s021ltr.pdf
01/23/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf
09/14/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020528s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s019ltr.pdf
01/23/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s018ltr.pdf
11/10/2011 SUPPL-17 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020528s017ltr.pdf
04/08/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020528s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020528s016ltr.pdf
04/20/2010 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020528s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020528s012ltr.pdf
02/06/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20528slr008ltr.pdf
08/20/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/05/2000 SUPPL-4 Labeling

Label is not available on this site.

10/26/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/24/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/02/1997 SUPPL-1 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020528_s001ap.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020528s025lbl.pdf
01/29/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf
12/24/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020528s023lbl.pdf
09/11/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s021lbl.pdf
01/23/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf
01/23/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf
09/14/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020528s019lbl.pdf
04/20/2010 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020528s012lbl.pdf
04/08/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020528s016lbl.pdf

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