JANSSEN BIOTECH FDA Approval BLA 761145

BLA 761145

JANSSEN BIOTECH

FDA Drug Application

Application #761145

Documents

Label2020-05-01
Letter2020-05-05

Application Sponsors

BLA 761145JANSSEN BIOTECH

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION120MG;2000UNITS/ML0DARZALEX FASPRODARATUMUMAB;HYALURONIDASE-FIHJ

FDA Submissions

UNKNOWN; ORIG1AP2020-05-01STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

JANSSEN BIOTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761145
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARZALEX FASPRO","activeIngredients":"DARATUMUMAB;HYALURONIDASE-FIHJ","strength":"120MG;2000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761145s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/01\/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\\\/761145s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761145Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-01
        )

)

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