Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020818
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription AB Yes No
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription AB Yes No
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription AB Yes No
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription AB Yes No
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/06/1998 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_PRNTLBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020818_diovan_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2019 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020818s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020818Orig1s075ltr.pdf
08/01/2016 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

11/13/2015 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/27/2015 SUPPL-66 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020818s066lbl.pdf
05/22/2015 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/24/2014 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s064ltr.pdf
03/17/2014 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf
05/30/2014 SUPPL-60 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s060ltr.pdf
04/23/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/17/2014 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf
10/04/2012 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818Orig1s056ltr.pdf
07/26/2012 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf
01/18/2012 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf
02/16/2012 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818s051ltr.pdf
12/12/2011 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf
06/03/2011 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s047ltr.pdf
12/12/2011 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf
04/21/2010 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020818s043ltr.pdf
07/31/2008 SUPPL-36 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020818s036ltr.pdf
09/06/2007 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020818s035_ltr.pdf
11/20/2006 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s032ltr.pdf
04/28/2006 SUPPL-27 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s027LTR.pdf
07/07/2005 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020818s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020818s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20818s024PiJul7.pdf
01/15/2003 SUPPL-16 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818S016_Diovan_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818s016_Diovan.cfm
08/01/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/06/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/17/2002 SUPPL-12 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20818s12ltr.pdf
10/23/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/27/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/02/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/01/2000 SUPPL-6 Labeling

Label is not available on this site.

04/18/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1999 SUPPL-4 Labeling

Label is not available on this site.

04/28/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2019 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020818s075lbl.pdf
07/27/2015 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020818s066lbl.pdf
09/24/2014 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s064lbl.pdf
05/30/2014 SUPPL-60 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf
03/17/2014 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf
03/17/2014 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf
10/04/2012 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s056lbl.pdf
07/26/2012 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s054lbl.pdf
02/16/2012 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf
01/18/2012 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf
12/12/2011 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s049lbl.pdf
12/12/2011 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s046lbl.pdf
06/03/2011 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s047lbl.pdf
04/21/2010 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf
11/20/2006 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf
04/28/2006 SUPPL-27 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf
07/07/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020818s024lbl.pdf
03/06/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_PRNTLBL.PDF

DIOVAN HCT

TABLET;ORAL; 12.5MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

TABLET;ORAL; 12.5MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

TABLET;ORAL; 25MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

TABLET;ORAL; 12.5MG;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

TABLET;ORAL; 25MG;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

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