ALKEM LABS LTD FDA Approval ANDA 213374

ANDA 213374

ALKEM LABS LTD

FDA Drug Application

Application #213374

Application Sponsors

ANDA 213374ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001GRANULE;ORAL90MG0DEFERASIROXDEFERASIROX
002GRANULE;ORAL180MG0DEFERASIROXDEFERASIROX
003GRANULE;ORAL360MG0DEFERASIROXDEFERASIROX

FDA Submissions

UNKNOWN; ORIG1AP2020-07-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213374
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"90MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"180MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"360MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-14
        )

)

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