NDA 215206

ABBVIE INC

FDA Drug Application

Application #215206

Documents

• Letter: 2021-09-29
• Label: 2021-09-29
• Review: 2021-11-01

Application Sponsors

NDA 215206

ABBVIE INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	10MG	2	QULIPTA	ATOGEPANT
002	TABLET;ORAL	30MG	2	QULIPTA	ATOGEPANT
003	TABLET;ORAL	60MG	2	QULIPTA	ATOGEPANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-09-28

PRIORITY

Submissions Property Types

ORIG

1

Null

40

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215206
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QULIPTA","activeIngredients":"ATOGEPANT","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"QULIPTA","activeIngredients":"ATOGEPANT","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"QULIPTA","activeIngredients":"ATOGEPANT","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"09\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215206Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215206Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215206Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-09-28
        )

)