BLA 761163

MORPHOSYS US INC

FDA Drug Application

Application #761163

Documents

• Label: 2020-07-31
• Letter: 2020-08-03
• Review: 2020-08-27
• Letter: 2021-06-03
• Label: 2021-06-03

Application Sponsors

BLA 761163

MORPHOSYS US INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

12MG/KG

0

Monjuvi (tafasitamab-cxix) for injection

TAFASITAMAB-CXIX

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-07-31

PRIORITY

Submissions Property Types

ORIG

1

Null

30

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
        )

)