HOSPIRA INC FDA Approval ANDA 065226

ANDA 065226

HOSPIRA INC

FDA Drug Application

Application #065226

Application Sponsors

ANDA 065226HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0CEFAZOLIN SODIUMCEFAZOLIN SODIUM
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0CEFAZOLIN SODIUMCEFAZOLIN SODIUM

FDA Submissions

ORIG1AP2005-04-21
LABELING; LabelingSUPPL3AP2007-10-26
LABELING; LabelingSUPPL5AP2009-01-15
LABELING; LabelingSUPPL7AP2009-09-30
LABELING; LabelingSUPPL11AP2014-05-05STANDARD

Submissions Property Types

SUPPL7Null7
SUPPL11Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65226
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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