Application Sponsors
ANDA 208847 | UMEDICA LABS PVT LTD | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | TABLET;ORAL | 12.5MG;20MG | 0 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
002 | TABLET;ORAL | 25MG;40MG | 0 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
003 | TABLET;ORAL | 12.5MG;40MG | 0 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-09-17 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-01-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
UMEDICA LABS PVT LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208847
[companyName] => UMEDICA LABS PVT LTD
[docInserts] => ["",""]
[products] => [{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"25MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-09-17
)
)