HOSPIRA INC FDA Approval ANDA 203950

ANDA 203950

HOSPIRA INC

FDA Drug Application

Application #203950

Documents

Letter2015-12-16

Application Sponsors

ANDA 203950HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2015-12-11

Submissions Property Types

ORIG1Null7

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203950
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203950Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-11
        )

)

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