BLA 761054

SAMSUNG BIOEPIS CO LTD

FDA Drug Application

Application #761054

Documents

• Label: 2017-04-21
• Medication Guide: 2017-04-21
• Letter: 2017-04-24
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Label: 2018-12-10
• Review: 2018-12-10
• Label: 2019-03-22
• Medication Guide: 2019-03-22
• Letter: 2019-06-27
• Label: 2019-06-28
• Medication Guide: 2019-06-28
• Letter: 2022-01-31
• Label: 2022-01-31

Application Sponsors

BLA 761054

SAMSUNG BIOEPIS CO LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG

0

RENFLEXIS

INFLIXIMAB-ABDA

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-04-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-03-21	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2019-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2022-01-27	N/A

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	9	Null	7

CDER Filings

SAMSUNG BIOEPIS CO LTD

cder:Array
(
    [0] => Array
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            [ApplNo] => 761054
            [companyName] => SAMSUNG BIOEPIS CO LTD
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761054s009lbl.pdf#page=52"]
            [products] => [{"drugName":"RENFLEXIS","activeIngredients":"INFLIXIMAB-ABDA","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/26\/2019","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761054s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761054s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761054Orig1s000lbledt.pdf\"}]","notes":""},{"actionDate":"04\/21\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761054Orig1s000TOC.cfm\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761054Orig1s000TOC.cfm\"},{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761054Orig1s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761054Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761054Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/26\/2019","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761054s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761054Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"03\/21\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761054s004lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2019-06-26
        )

)