TORRENT FDA Approval ANDA 215908

ANDA 215908

TORRENT

FDA Drug Application

Application #215908

Application Sponsors

ANDA 215908TORRENT

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL2MG0NITISINONENITISINONE
002CAPSULE;ORAL5MG0NITISINONENITISINONE
003CAPSULE;ORAL10MG0NITISINONENITISINONE
004CAPSULE;ORAL20MG0NITISINONENITISINONE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215908
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-09
        )

)

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