NDA 214985

IDORSIA PHARMACEUTICALS LTD.

FDA Drug Application

Application #214985

Documents

• Letter: 2022-01-11
• Label: 2022-01-11
• Medication Guide: 2022-01-11
• Review: 2022-02-14
• Federal Register Notice: 2022-07-13
• Letter: 2022-11-09
• Label: 2022-11-10
• Medication Guide: 2022-11-10

Application Sponsors

NDA 214985

IDORSIA PHARMACEUTICALS LTD.

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET; ORAL	25MG	0	QUVIVIQ	DARIDOREXANT
002	TABLET; ORAL	50MG	0	QUVIVIQ	DARIDOREXANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2022-01-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

IDORSIA PHARMACEUTICALS LTD.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214985
            [companyName] => IDORSIA PHARMACEUTICALS LTD.
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/214985s000lbl.pdf#page=22"]
            [products] => [{"drugName":"QUVIVIQ","activeIngredients":"DARIDOREXANT","strength":"25MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"QUVIVIQ","activeIngredients":"DARIDOREXANT","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/07\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214985s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/07\/2022","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\\\/2022\\\/214985s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214985Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-07
        )

)