Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020665
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIOVAN VALSARTAN 80MG CAPSULE;ORAL Discontinued None No No
DIOVAN VALSARTAN 160MG CAPSULE;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
12/23/1996 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/pre96/020665_s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/03/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020665s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020665Orig1s039ltr.pdf
07/27/2015 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020665s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020665Orig1s038ltr.pdf
09/24/2014 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s037ltr.pdf
02/16/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/17/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s034,s035ltr.pdf
03/17/2014 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020665Orig1s034,s035ltr.pdf
10/29/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020665s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020665Orig1s033ltr.pdf
08/01/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/06/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/14/2002 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20665se1-016,21283se1-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s001_Diovan.cfm
10/23/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/02/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/27/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/18/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/29/1999 SUPPL-8 Labeling

Label is not available on this site.

12/03/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/27/1998 SUPPL-4 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020665s004_diovan_toc.cfm
08/18/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/15/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/27/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/03/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020665s039lbl.pdf
07/27/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020665s038lbl.pdf
09/24/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s037lbl.pdf
03/17/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf
03/17/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020665s034s035lbl.pdf
10/29/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020665s033lbl.pdf
08/14/2002 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20665s16lbl.pdf

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