NDA 211765

ALLERGAN

FDA Drug Application

Application #211765

Documents

• Label: 2019-12-23
• Letter: 2019-12-26
• Review: 2020-01-22
• Letter: 2021-03-04

Application Sponsors

NDA 211765

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	1	UBRELVY	UBROGEPANT
002	TABLET;ORAL	100MG	1	UBRELVY	UBROGEPANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-12-23	STANDARD
LABELING; Labeling	SUPPL	2	TA	2020-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211765
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"UBRELVY","activeIngredients":"UBROGEPANT","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"UBRELVY","activeIngredients":"UBROGEPANT","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211765s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211765s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211765Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211765Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)