HOSPIRA INC FDA Approval ANDA 078815

ANDA 078815

HOSPIRA INC

FDA Drug Application

Application #078815

Documents

Review2013-04-23

Application Sponsors

ANDA 078815HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INTRAVENOUS50MG/VIAL0OXALIPLATINOXALIPLATIN
002INJECTABLE;INTRAVENOUS100MG/VIAL0OXALIPLATINOXALIPLATIN

FDA Submissions

ORIG1AP2009-09-30
LABELING; LabelingSUPPL2AP2016-06-24STANDARD
LABELING; LabelingSUPPL3AP2016-06-24STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78815
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXALIPLATIN","submission":"OXALIPLATIN","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXALIPLATIN","submission":"OXALIPLATIN","actionType":"100MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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