TORRENT FDA Approval ANDA 202375

ANDA 202375

TORRENT

FDA Drug Application

Application #202375

Application Sponsors

ANDA 202375TORRENT

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL5MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL
002TABLET;ORAL20MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL
003TABLET;ORAL40MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL

FDA Submissions

UNKNOWN; ORIG1AP2017-04-24
LABELING; LabelingSUPPL7AP2022-08-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL7Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202375
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-24
        )

)

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