Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203145
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
| 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 | 12.5MG;320MG | TABLET;ORAL | Prescription | AB | No | No |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/07/2023 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/14/2022 | SUPPL-26 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/20/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/29/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2015 | 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; 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;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; 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 |