Drugs@FDA: FDA-Approved Drugs
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 |