BLA 761091

CELLTRION INC

FDA Drug Application

Application #761091

Documents

• Label: 2018-12-14
• Letter: 2018-12-21
• Review: 2019-03-21
• Letter: 2019-05-17
• Letter: 2019-05-17
• Label: 2019-05-17
• Label: 2019-05-17

Application Sponsors

BLA 761091

CELLTRION INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

420MG

0

HERZUMA

TRASTUZUMAB-PKRB

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-14	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2019-05-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6

CDER Filings

CELLTRION INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761091
            [companyName] => CELLTRION INC
            [docInserts] => [{"name":"Skip to common links","url":"#footer-heading"},{"name":"Skip to topics menu","url":"#fda-topmenu-home"}]
            [products] => [{"drugName":"HERZUMA","activeIngredients":"TRASTUZUMAB-PKRB","strength":"420MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/16\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761091s001s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2019","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761091s001s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761091s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761091s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761091Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761091Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/16\/2019","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761091s001s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"05\/16\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761091s001s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2019-05-16
        )

)