SPECTRUM PHARMS FDA Approval BLA 761148

BLA 761148

SPECTRUM PHARMS

FDA Drug Application

Application #761148

Documents

Letter2022-09-13
Label2022-09-16

Application Sponsors

BLA 761148SPECTRUM PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUS13.2MG/0.6ML0ROLONTISEFLAPEGRASTIM-XNST

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-09STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

SPECTRUM PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761148
            [companyName] => SPECTRUM PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROLONTIS","activeIngredients":"EFLAPEGRASTIM-XNST","strength":"13.2MG\/0.6ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761148Orig1s000Corrected_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-09
        )

)

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