TORRENT FDA Approval ANDA 211835

ANDA 211835

TORRENT

FDA Drug Application

Application #211835

Application Sponsors

ANDA 211835TORRENT

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL40MG0APREPITANTAPREPITANT
002CAPSULE;ORAL80MG0APREPITANTAPREPITANT
003CAPSULE;ORAL125MG0APREPITANTAPREPITANT

FDA Submissions

UNKNOWN; ORIG1AP2020-10-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211835
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"APREPITANT","activeIngredients":"APREPITANT","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"APREPITANT","activeIngredients":"APREPITANT","strength":"80MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"APREPITANT","activeIngredients":"APREPITANT","strength":"125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

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