ALKEM LABS LTD FDA Approval ANDA 211143

ANDA 211143

ALKEM LABS LTD

FDA Drug Application

Application #211143

Application Sponsors

ANDA 211143ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
002TABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
003TABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE
004TABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATE0METOPROLOL SUCCINATEMETOPROLOL SUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211143
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 25MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 50MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 100MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 200MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)

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