HOSPIRA INC FDA Approval ANDA 091007

ANDA 091007

HOSPIRA INC

FDA Drug Application

Application #091007

Documents

Letter2011-11-21

Application Sponsors

ANDA 091007HOSPIRA INC

Marketing Status

Discontinued001

Application Products

001POWDER;INTRAVENOUSEQ 500MG BASE/VIAL;500MG/VIAL0IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEM

FDA Submissions

ORIG1AP2011-11-16
LABELING; LabelingSUPPL6AP2015-12-28STANDARD

Submissions Property Types

ORIG1Null15
SUPPL6Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91007
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIPENEM AND CILASTATIN","activeIngredients":"CILASTATIN SODIUM; IMIPENEM","strength":"EQ 500MG BASE\/VIAL;500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IMIPENEM AND CILASTATIN","submission":"CILASTATIN SODIUM; IMIPENEM","actionType":"EQ 500MG BASE\/VIAL;500MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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