AKORN FDA Approval ANDA 090450

ANDA 090450

AKORN

FDA Drug Application

Application #090450

Application Sponsors

ANDA 090450AKORN

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS60MG/20ML (3MG/ML)0ADENOSINEADENOSINE
002SOLUTION;INTRAVENOUS90MG/30ML (3MG/ML)0ADENOSINEADENOSINE

FDA Submissions

ORIG1AP2014-10-02

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90450
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADENOSINE","activeIngredients":"ADENOSINE","strength":"60MG\/20ML (3MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ADENOSINE","activeIngredients":"ADENOSINE","strength":"90MG\/30ML (3MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ADENOSINE","submission":"ADENOSINE","actionType":"60MG\/20ML (3MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ADENOSINE","submission":"ADENOSINE","actionType":"90MG\/30ML (3MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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