BAXTER HLTHCARE CORP FDA Approval ANDA 076427

ANDA 076427

BAXTER HLTHCARE CORP

FDA Drug Application

Application #076427

Application Sponsors

ANDA 076427BAXTER HLTHCARE CORP

Marketing Status

Discontinued001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0MILRINONE LACTATEMILRINONE LACTATE
002INJECTABLE; INJECTION20MG/20ML0MILRINONE LACTATEMILRINONE LACTATE

FDA Submissions

ORIG1AP2004-09-21
LABELING; LabelingSUPPL8AP2006-06-27

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76427
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILRINONE LACTATE","activeIngredients":"MILRINONE LACTATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MILRINONE LACTATE","activeIngredients":"MILRINONE LACTATE","strength":"20MG\/20ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MILRINONE LACTATE","submission":"MILRINONE LACTATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MILRINONE LACTATE","submission":"MILRINONE LACTATE","actionType":"20MG\/20ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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