BLA 761291

JANSSEN BIOTECH

FDA Drug Application

Application #761291

Documents

• Label: 2022-10-26
• Letter: 2022-10-27
• Review: 2022-11-23

Application Sponsors

BLA 761291

JANSSEN BIOTECH

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	30MG/3ML(10MG/ML)	0	TECAYLI	TECLISTAMAB-CQYV
002	INJECTABLE;INJECTION	153MG/1.7ML(90MG/ML)	0	TECAYLI	TECLISTAMAB-CQYV

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-10-25

PRIORITY

Submissions Property Types

ORIG

1

Null

6

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
        )

)