ALKEM LABS LTD FDA Approval ANDA 214753

ANDA 214753

ALKEM LABS LTD

FDA Drug Application

Application #214753

Application Sponsors

ANDA 214753ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL0.5MG0SIROLIMUSSIROLIMUS
002TABLET;ORAL1MG0SIROLIMUSSIROLIMUS
003TABLET;ORAL2MG0SIROLIMUSSIROLIMUS

FDA Submissions

UNKNOWN; ORIG1AP2021-03-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214753
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-12
        )

)

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