BLA 761210

JANSSEN BIOTECH

FDA Drug Application

Application #761210

Documents

• Label: 2021-05-21
• Letter: 2021-05-24
• Review: 2021-06-23
• Letter: 2021-12-22
• Label: 2021-12-23
• Label: 2022-11-07
• Letter: 2022-11-07

Application Sponsors

BLA 761210

JANSSEN BIOTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

350MG/7ML(50MG/ML)

0

RYBREVANT

AMIVANTAMAB-VMJW

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-05-21	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-11-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6

CDER Filings

JANSSEN BIOTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761210
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYBREVANT","activeIngredients":"AMIVANTAMAB-VMJW","strength":"350MG\/7ML(50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761210s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761210s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761210Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)