JANSSEN BIOTECH FDA Approval BLA 761291

BLA 761291

JANSSEN BIOTECH

FDA Drug Application

Application #761291

Documents

Label2022-10-26
Letter2022-10-27
Review2022-11-23

Application Sponsors

BLA 761291JANSSEN BIOTECH

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION30MG/3ML(10MG/ML)0TECAYLITECLISTAMAB-CQYV
002INJECTABLE;INJECTION153MG/1.7ML(90MG/ML)0TECAYLITECLISTAMAB-CQYV

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-10-25PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

JANSSEN BIOTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761291
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECAYLI","activeIngredients":"TECLISTAMAB-CQYV","strength":"30MG\/3ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"TECAYLI","activeIngredients":"TECLISTAMAB-CQYV","strength":"153MG\/1.7ML(90MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-25
        )

)

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