BLA 761143

HORIZON THERAPEUTICS IRELAND

FDA Drug Application

Application #761143

Documents

• Letter: 2020-01-22
• Label: 2020-01-22
• Review: 2020-03-02
• Letter: 2021-10-27
• Label: 2021-10-27
• Label: 2022-12-07
• Letter: 2022-12-07

Application Sponsors

BLA 761143

HORIZON THERAPEUTICS IRELAND

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG

2

TEPEZZA

TEPROTUMUMAB-TRBW

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-01-21	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2021-10-26	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	14	Null	6
SUPPL	21	Null	6

CDER Filings

HORIZON THERAPEUTICS IRELAND

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761143
            [companyName] => HORIZON THERAPEUTICS IRELAND
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEPEZZA","activeIngredients":"TEPROTUMUMAB-TRBW","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761143s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761143s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761143Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761143Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-01-21
        )

)