BLA 761067

SUN PHARMA GLOBAL

FDA Drug Application

Application #761067

Documents

• Letter: 2018-03-22
• Label: 2018-03-23
• Medication Guide: 2018-03-23
• Review: 2018-04-26
• Label: 2022-12-21
• Letter: 2022-12-21

Application Sponsors

BLA 761067

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/1ML

0

ILUMYA

TILDRAKIZUMAB-ASMN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-03-20	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2022-12-19	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	14	Null	6

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761067
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/761067s000lbl.pdf#page=10"]
            [products] => [{"drugName":"ILUMYA","activeIngredients":"TILDRAKIZUMAB-ASMN","strength":"100MG\/1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/20\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761067s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761067s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761067Orig1s000REPLACEMENT_ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761067Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-03-20
        )

)