BLA 761059

SAMSUNG BIOEPIS CO LTD

FDA Drug Application

Application #761059

Documents

• Label: 2019-07-23
• Medication Guide: 2019-07-23
• Letter: 2019-09-05
• Review: 2019-09-05
• Letter: 2022-06-21
• Label: 2022-06-21
• Medication Guide: 2022-06-21
• Letter: 2022-08-16
• Label: 2022-08-17
• Letter: 2022-12-27
• Label: 2023-01-03

Application Sponsors

BLA 761059

SAMSUNG BIOEPIS CO LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/0.8ML

0

HADLIMA

ADALIMUMAB-BWWD

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-07-23	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2022-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2022-08-15	STANDARD
LABELING; Labeling	SUPPL	7	TA	2022-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	7
SUPPL	5	Null	46

CDER Filings

SAMSUNG BIOEPIS CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761059
            [companyName] => SAMSUNG BIOEPIS CO LTD
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761059s000lbl.pdf#page=36"]
            [products] => [{"drugName":"HADLIMA","activeIngredients":"ADALIMUMAB-BWWD","strength":"40MG\/0.8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/23\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761059s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761059s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761059Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761059Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-07-23
        )

)