MORPHOSYS US INC FDA Approval BLA 761163

BLA 761163

MORPHOSYS US INC

FDA Drug Application

Application #761163

Documents

Label2020-07-31
Letter2020-08-03
Review2020-08-27

Application Sponsors

BLA 761163MORPHOSYS US INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION12MG/KG0Monjuvi (tafasitamab-cxix) for injectionTAFASITAMAB-CXIX

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-07-31PRIORITY

Submissions Property Types

ORIG1Null30

CDER Filings

MORPHOSYS US INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761163
            [companyName] => MORPHOSYS US INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"Monjuvi (tafasitamab-cxix) for injection","activeIngredients":"TAFASITAMAB-CXIX","strength":"12MG\/KG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/31\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761163s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761163s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761163Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-31
        )

)

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