AM REGENT FDA Approval ANDA 090656

ANDA 090656

AM REGENT

FDA Drug Application

Application #090656

Application Sponsors

ANDA 090656AM REGENT

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION20MG/2ML (10MG/ML)0TORSEMIDETORSEMIDE
002INJECTABLE;INJECTION50MG/5ML (10MG/ML)0TORSEMIDETORSEMIDE

FDA Submissions

ORIG1AP2010-04-21

Submissions Property Types

ORIG1Null1

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90656
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"20MG\/2ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"50MG\/5ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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