Drugs@FDA: FDA-Approved Drugs
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | AB | No | No |
VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET;ORAL | Prescription | AB | No | No |
VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/21/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078020Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/11/2024 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/06/2019 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/01/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/15/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
07/15/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
12/14/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
VALSARTAN AND HYDROCHLOROTHIAZIDE
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 |