HOSPIRA INC FDA Approval ANDA 202864

ANDA 202864

HOSPIRA INC

FDA Drug Application

Application #202864

Documents

Letter2015-09-09

Application Sponsors

ANDA 202864HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001INJECTABLE;INJECTIONEQ 250MG BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
002INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
003INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
004INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2015-09-04

Submissions Property Types

ORIG1Null7

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202864
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202864Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/15\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-02-15
        )

)

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