Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202544
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | AB | No | No |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | 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 |
---|---|---|---|---|---|---|---|
03/04/2019 | 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 |
---|---|---|---|---|---|
07/12/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
01/24/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
TELMISARTAN AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 12.5MG;40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021162 | BOEHRINGER INGELHEIM |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 203010 | ALEMBIC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 208727 | AUROBINDO PHARMA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 202544 | GLENMARK PHARMS LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 091351 | LUPIN LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 209028 | PRINSTON INC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 204221 | ZYDUS PHARMS |
TABLET;ORAL; 12.5MG;80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 021162 | BOEHRINGER INGELHEIM |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 203010 | ALEMBIC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 208727 | AUROBINDO PHARMA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 202544 | GLENMARK PHARMS LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 091351 | LUPIN LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 209028 | PRINSTON INC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Prescription | No | AB | 204221 | ZYDUS PHARMS |
TABLET;ORAL; 25MG;80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MICARDIS HCT | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 021162 | BOEHRINGER INGELHEIM |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 203010 | ALEMBIC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 208727 | AUROBINDO PHARMA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 202544 | GLENMARK PHARMS LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 091351 | LUPIN LTD |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 209028 | PRINSTON INC |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Prescription | No | AB | 204221 | ZYDUS PHARMS |