Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208847
Company: UMEDICA
Company: UMEDICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | AB | No | No |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | 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 |
---|---|---|---|---|---|---|---|
09/17/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/25/2021 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 12.5MG;20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 021532 | COSETTE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 209281 | ACCORD HLTHCARE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 204233 | ALEMBIC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 204801 | MACLEODS PHARMS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 207804 | PRINSTON INC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA |
TABLET;ORAL; 25MG;40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021532 | COSETTE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 209281 | ACCORD HLTHCARE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 204233 | ALEMBIC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 204801 | MACLEODS PHARMS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207804 | PRINSTON INC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA |
TABLET;ORAL; 12.5MG;40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021532 | COSETTE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 209281 | ACCORD HLTHCARE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 204233 | ALEMBIC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 204801 | MACLEODS PHARMS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207804 | PRINSTON INC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 200532 | TEVA PHARMS USA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA |