HOSPIRA INC FDA Approval BLA 761111

BLA 761111

HOSPIRA INC

FDA Drug Application

Application #761111

Documents

Label2020-06-11
Letter2020-06-12

Application Sponsors

BLA 761111HOSPIRA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION6MG/0.6ML0NYVEPRIAPEGFILGRASTIM-APGF

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2020-06-10STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761111
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYVEPRIA","activeIngredients":"PEGFILGRASTIM-APGF","strength":"6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761111lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761111Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-10
        )

)

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