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
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
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
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 PHARMS LTD
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 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
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 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

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 PHARMS LTD
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 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
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 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

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 PHARMS LTD
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 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
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 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

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 PHARMS LTD
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 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
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 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

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