TORRENT FDA Approval ANDA 212062

ANDA 212062

TORRENT

FDA Drug Application

Application #212062

Application Sponsors

ANDA 212062TORRENT

Marketing Status

Prescription001

Application Products

001TABLET;ORAL20MG0TADALAFILTADALAFIL

FDA Submissions

UNKNOWN; ORIG1AP2019-03-26STANDARD
LABELING; LabelingSUPPL2AP2021-01-26STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAB2

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212062
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-26
        )

)

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