BIOVERATIV THERAPEUTICS INC FDA Approval BLA 761164

BLA 761164

BIOVERATIV THERAPEUTICS INC

FDA Drug Application

Application #761164

Documents

Label2022-02-04
Medication Guide2022-02-04
Letter2022-02-18
Review2022-03-04

Application Sponsors

BLA 761164BIOVERATIV THERAPEUTICS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1,100MG/22ML(50MG/ML)0ENJAYMOSUTIMLIMAB-JOME

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-02-04PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761164
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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