Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020665
Company: NOVARTIS
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 |