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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021283
Company: NOVARTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIOVAN VALSARTAN 80MG TABLET;ORAL Prescription AB Yes No
DIOVAN VALSARTAN 160MG TABLET;ORAL Prescription AB Yes No
DIOVAN VALSARTAN 320MG TABLET;ORAL Prescription AB Yes Yes
DIOVAN VALSARTAN 40MG TABLET;ORAL Prescription AB Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/21/2025 SUPPL-62 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021283Orig1s062lbl.pdf
07/22/2021 SUPPL-59 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283Orig1s059lbl.pdf
04/19/2021 SUPPL-58 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf
06/12/2019 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021283s053lbl.pdf
02/03/2017 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021283s50lbl.pdf
07/27/2015 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021283s046lbl.pdf
09/26/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s044lbl.pdf
03/17/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf
03/17/2014 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf
10/04/2012 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s039lbl.pdf
07/26/2012 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s037lbl.pdf
02/28/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s035lbl.pdf
01/18/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s036lbl.pdf
12/12/2011 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf
06/03/2011 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s032lbl.pdf
06/15/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021283s027lbl.pdf
11/29/2007 SUPPL-24 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021283s024lbl.pdf
11/22/2006 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021283s018lbl.pdf
08/03/2005 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021283s011lbl.pdf
11/30/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21283s012lbl.pdf
11/06/2002 SUPPL-4 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20665S004_DIOVAN_PRNTLBL.PDF
08/14/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf
04/05/2002 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283S002_Diovan_prntlbl.pdf
07/18/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21283lbl.pdf
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