AUROBINDO PHARMA LTD FDA Approval ANDA 209666

ANDA 209666

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209666

Application Sponsors

ANDA 209666AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)0MILRINONE LACTATE IN DEXTROSE 5%MILRINONE LACTATE
002INJECTABLE;INJECTIONEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)0MILRINONE LACTATE IN DEXTROSE 5%MILRINONE LACTATE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209666
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILRINONE LACTATE IN DEXTROSE 5%","activeIngredients":"MILRINONE LACTATE","strength":"EQ 20MG BASE\/100ML (EQ 0.2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MILRINONE LACTATE IN DEXTROSE 5%","activeIngredients":"MILRINONE LACTATE","strength":"EQ 40MG BASE\/200ML (EQ 0.2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-03
        )

)

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