Documents
Application Sponsors
BLA 761143 | HORIZON THERAPEUTICS IRELAND | |
Marketing Status
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
)
)