Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020818
Company: NOVARTIS
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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020818s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020818Orig1s080ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020818s080lbl.pdf | |
| 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 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 204382 | AMNEAL PHARMS |
| 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 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 204382 | AMNEAL PHARMS |
| 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 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET;ORAL | Prescription | No | AB | 204382 | AMNEAL PHARMS |
| 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 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET;ORAL | Prescription | No | AB | 204382 | AMNEAL PHARMS |
| 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 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET;ORAL | Prescription | No | AB | 204382 | AMNEAL PHARMS |
| 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 |