BLA 761066

SAMSUNG BIOEPIS CO LTD

FDA Drug Application

Application #761066

Documents

• Label: 2019-04-26
• Medication Guide: 2019-04-26
• Letter: 2019-04-29
• Review: 2019-06-18

Application Sponsors

BLA 761066

SAMSUNG BIOEPIS CO LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	25MG/0.5ML	0	ETICOVO	ETANERCEPT-YKRO
002	INJECTABLE;INJECTION	50MG/1ML	0	ETICOVO	ETANERCEPT-YKRO

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2019-04-25

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SAMSUNG BIOEPIS CO LTD

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(
    [0] => Array
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            [ApplNo] => 761066
            [companyName] => SAMSUNG BIOEPIS CO LTD
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761066s000lbl.pdf#page=31"]
            [products] => [{"drugName":"ETICOVO","activeIngredients":"ETANERCEPT-YKRO","strength":"25MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ETICOVO","activeIngredients":"ETANERCEPT-YKRO","strength":"50MG\/1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/25\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761066s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761066s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761066Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761066Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-04-25
        )

)