HOSPIRA INC FDA Approval ANDA 065232

ANDA 065232

HOSPIRA INC

FDA Drug Application

Application #065232

Documents

Other Important Information from FDA2008-09-19

Application Sponsors

ANDA 065232HOSPIRA INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0CEFTRIAXONECEFTRIAXONE SODIUM

FDA Submissions

ORIG1AP2005-08-02
LABELING; LabelingSUPPL6AP2008-11-14
LABELING; LabelingSUPPL9AP2008-11-14
LABELING; LabelingSUPPL10AP2009-08-27
LABELING; LabelingSUPPL11AP2009-08-27
LABELING; LabelingSUPPL12AP2010-09-10
LABELING; LabelingSUPPL13AP2012-02-17

Submissions Property Types

SUPPL10Null7
SUPPL11Null7
SUPPL12Null7
SUPPL13Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65232
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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