TORRENT FDA Approval ANDA 215016

ANDA 215016

TORRENT

FDA Drug Application

Application #215016

Application Sponsors

ANDA 215016TORRENT

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL1MG/ML0SIROLIMUSSIROLIMUS

FDA Submissions

UNKNOWN; ORIG1AP2021-12-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215016
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-27
        )

)

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