APOTEX FDA Approval ANDA 203180

ANDA 203180

APOTEX

FDA Drug Application

Application #203180

Documents

Letter2021-12-20

Application Sponsors

ANDA 203180APOTEX

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL80MG0DASATINIBDASATINIB
002TABLET;ORAL140MG0DASATINIBDASATINIB

FDA Submissions

UNKNOWN; ORIG1AP2021-11-23

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203180
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-23
        )

)

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