ALKEM LABS LTD FDA Approval ANDA 212451

ANDA 212451

ALKEM LABS LTD

FDA Drug Application

Application #212451

Documents

Letter2021-01-07

Application Sponsors

ANDA 212451ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL15MG0MORPHINE SULFATEMORPHINE SULFATE
002TABLET;ORAL30MG0MORPHINE SULFATEMORPHINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212451
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-03
        )

)

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