AM REGENT FDA Approval ANDA 090386

ANDA 090386

AM REGENT

FDA Drug Application

Application #090386

Application Sponsors

ANDA 090386AM REGENT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1MG/ML0METOPROLOL TARTRATEMETOPROLOL TARTRATE

FDA Submissions

ORIG1AP2009-09-30
LABELING; LabelingSUPPL3AP2019-10-30STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90386
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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