WOODWARD FDA Approval ANDA 209708

ANDA 209708

WOODWARD

FDA Drug Application

Application #209708

Application Sponsors

ANDA 209708WOODWARD

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUSEQ 10MG BASE/5ML (EQ 2MG BASE/ML)0MIVACURIUM CHLORIDEMIVACURIUM CHLORIDE
002SOLUTION;INTRAVENOUSEQ 20MG BASE/10ML (EQ 2MG BASE/ML)0MIVACURIUM CHLORIDEMIVACURIUM CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-12STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

WOODWARD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209708
            [companyName] => WOODWARD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIVACURIUM CHLORIDE","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 10MG BASE\/5ML (EQ 2MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MIVACURIUM CHLORIDE","activeIngredients":"MIVACURIUM CHLORIDE","strength":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-12
        )

)

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