BLA 761164

BIOVERATIV THERAPEUTICS INC

FDA Drug Application

Application #761164

Documents

• Label: 2022-02-04
• Medication Guide: 2022-02-04
• Letter: 2022-02-18
• Review: 2022-03-04
• Letter: 2022-10-20
• Letter: 2023-01-26
• Label: 2023-01-26
• Medication Guide: 2023-01-26

Application Sponsors

BLA 761164

BIOVERATIV THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1,100MG/22ML(50MG/ML)

0

ENJAYMO

SUTIMLIMAB-JOME

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2022-02-04	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2023-01-25	PRIORITY

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	6

CDER Filings

Accessdata Error

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

)