BLA 761202

SAMSUNG BIOEPIS CO LTD

FDA Drug Application

Application #761202

Documents

• Label: 2021-09-20
• Letter: 2021-09-21
• Review: 2021-10-01
• Letter: 2022-06-10
• Label: 2022-06-13
• Letter: 2022-08-16

Application Sponsors

BLA 761202

SAMSUNG BIOEPIS CO LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.5MG(10MG/ML)

0

BYOOVIZ

RANIBIZUMAB-NUNA

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2021-09-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-08-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	6
SUPPL	4	Null	7

CDER Filings

SAMSUNG BIOEPIS CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761202
            [companyName] => SAMSUNG BIOEPIS CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BYOOVIZ","activeIngredients":"RANIBIZUMAB-NUNA","strength":"0.5MG(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761202s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761202s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761202Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-09-17
        )

)