BLA 125544

CELLTRION INC

FDA Drug Application

Application #125544

Documents

• Label: 2016-04-05
• Review: 2016-06-27
• Medication Guide: 2016-04-27
• Letter: 2016-04-05
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Addendum: 1900-01-01
• Letter: 2018-07-30
• Label: 2019-03-07
• Letter: 2019-06-19
• Medication Guide: 2019-06-20
• Label: 2019-06-20
• Label: 2021-06-24
• Medication Guide: 2021-06-24

Application Sponsors

BLA 125544

CELLTRION INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG

2

INFLECTRA

INFLIXIMAB-DYYB

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2016-04-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-07-27	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2019-06-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-06-17	STANDARD

Submissions Property Types

ORIG	1	Null	12
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	18	Null	7

CDER Filings

CELLTRION INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125544
            [companyName] => CELLTRION INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125544s009lbl.pdf#page=59"]
            [products] => [{"drugName":"INFLECTRA","activeIngredients":"INFLIXIMAB-DYYB","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/18\/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\\\/125544s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125544s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125544s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125544s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/05\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125544s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125544Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125544Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/18\/2019","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125544s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125544Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2018","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125544s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125544Orig1s008Ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-06-18
        )

)