Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021283
Company: NOVARTIS
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/18/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21283lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021283_ORIGINAL_APPROVAL_PACKAGE.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/22/2021 | SUPPL-59 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283Orig1s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021283Orig1s059ltr.pdf | |
| 04/19/2021 | SUPPL-58 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021283Orig1s058ltr.pdf | |
| 06/12/2019 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021283s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021283Orig1s053ltr.pdf | |
| 02/03/2017 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021283s50lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021283Orig1s050ltr.pdf | |
| 07/31/2015 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2015 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021283s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021283Orig1s046ltr.pdf | |
| 09/26/2014 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s044ltr.pdf | |
| 03/17/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s041,s042ltr.pdf | |
| 03/17/2014 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021283Orig1s041,s042ltr.pdf | |
| 10/18/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2012 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s039ltr.pdf | |
| 07/26/2012 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf | |
| 01/18/2012 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf | |
| 02/28/2012 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021283s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s035ltr.pdf | |
| 12/12/2011 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021283s033ltr.pdf | |
| 06/03/2011 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021283s032ltr.pdf | |
| 06/15/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021283s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021283s027ltr.pdf | |
| 11/29/2007 | SUPPL-24 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021283s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021283s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021283Orig1s024.pdf | |
| 08/17/2007 | SUPPL-21 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021283s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021283Orig1s021.pdf |
| 11/22/2006 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021283s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021283s018ltr.pdf | |
| 11/30/2004 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21283s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21283s012ltr.pdf | |
| 08/03/2005 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021283s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021283s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021283_S011_DIOVANTOC.cfm | |
| 08/01/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20665S004_DIOVAN_PRNTLBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020665s004_diovan_toc.cfm | |
| 04/29/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2002 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283S002_Diovan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21283s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-283s002_Diovan.cfm | |
| 08/14/2002 | SUPPL-1 | 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
DIOVAN
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |
TABLET;ORAL; 160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |
TABLET;ORAL; 320MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |