HOSPIRA INC FDA Approval ANDA 203883

ANDA 203883

HOSPIRA INC

FDA Drug Application

Application #203883

Application Sponsors

ANDA 203883HOSPIRA INC

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2014-03-24

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203883
            [companyName] => HOSPIRA INC
            [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":"03\/24\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-09-17
        )

)

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