INDOCO FDA Approval ANDA 209898

ANDA 209898

INDOCO

FDA Drug Application

Application #209898

Application Sponsors

ANDA 209898INDOCO

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL2.5MG0APIXABANAPIXABAN
002TABLET;ORAL5MG0APIXABANAPIXABAN

FDA Submissions

UNKNOWN; ORIG1AP2020-09-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

INDOCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209898
            [companyName] => INDOCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-14
        )

)

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