HOSPIRA INC FDA Approval ANDA 065290

ANDA 065290

HOSPIRA INC

FDA Drug Application

Application #065290

Application Sponsors

ANDA 065290HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0CEFOTAXIME SODIUMCEFOTAXIME SODIUM
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0CEFOTAXIME SODIUMCEFOTAXIME SODIUM
003INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0CEFOTAXIME SODIUMCEFOTAXIME SODIUM

FDA Submissions

ORIG1AP2006-08-11
LABELING; LabelingSUPPL2AP2012-06-26

Submissions Property Types

SUPPL2Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65290
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOTAXIME SODIUM","activeIngredients":"CEFOTAXIME SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOTAXIME SODIUM","activeIngredients":"CEFOTAXIME SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOTAXIME SODIUM","activeIngredients":"CEFOTAXIME SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFOTAXIME SODIUM","submission":"CEFOTAXIME SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOTAXIME SODIUM","submission":"CEFOTAXIME SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOTAXIME SODIUM","submission":"CEFOTAXIME SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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