ALKEM LABS LTD FDA Approval ANDA 209953

ANDA 209953

ALKEM LABS LTD

FDA Drug Application

Application #209953

Application Sponsors

ANDA 209953ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0RANOLAZINERANOLAZINE
002TABLET, EXTENDED RELEASE;ORAL1GM0RANOLAZINERANOLAZINE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-30STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209953
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)

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