BLA 761100

SAMSUNG BIOEPIS CO LTD

FDA Drug Application

Application #761100

Documents

• Label: 2019-01-18
• Letter: 2019-03-07
• Review: 2019-03-05
• Letter: 2022-02-07
• Label: 2022-02-07

Application Sponsors

BLA 761100

SAMSUNG BIOEPIS CO LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	150MG	0	ONTRUZANT	TRASTUZUMAB-DTTB
002	POWDER;IV (INFUSION)	420MG	0	ONTRUZANT	TRASTUZUMAB-DTTB

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2020-03-19	N/A

Submissions Property Types

ORIG

1

Null

7

CDER Filings

SAMSUNG BIOEPIS CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761100
            [companyName] => SAMSUNG BIOEPIS CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONTRUZANT","activeIngredients":"TRASTUZUMAB-DTTB","strength":"150MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761100s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761100s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761100Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761100Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-01-18
        )

)