HOSPIRA INC FDA Approval ANDA 065231

ANDA 065231

HOSPIRA INC

FDA Drug Application

Application #065231

Documents

Other Important Information from FDA2008-09-19

Application Sponsors

ANDA 065231HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0CEFTRIAXONECEFTRIAXONE SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0CEFTRIAXONECEFTRIAXONE SODIUM

FDA Submissions

ORIG1AP2005-08-02
LABELING; LabelingSUPPL7AP2008-11-14
LABELING; LabelingSUPPL10AP2008-11-14
LABELING; LabelingSUPPL11AP2009-08-27
LABELING; LabelingSUPPL12AP2009-08-27
LABELING; LabelingSUPPL13AP2010-08-31
LABELING; LabelingSUPPL14AP2011-04-20

Submissions Property Types

SUPPL11Null7
SUPPL12Null7
SUPPL13Null7

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65231
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.