NDA 215390

BIOXCEL THERAPEUTICS, INC.

FDA Drug Application

Application #215390

Documents

• Letter: 2022-04-06
• Label: 2022-04-11
• Letter: 2022-10-25
• Review: 2023-01-23
• Review: 2023-01-23

Application Sponsors

NDA 215390

BIOXCEL THERAPEUTICS, INC.

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FILM;SUBLINGUAL		0	IGALMI	DEXMEDETOMIDINE
002	FILM;SUBLINGUAL	180MCG	0	IGALMI	DEXMEDETOMIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-04-05

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

BIOXCEL THERAPEUTICS, INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215390
            [companyName] => BIOXCEL THERAPEUTICS, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"IGALMI","activeIngredients":"DEXMEDETOMIDINE","strength":"","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IGALMI","activeIngredients":"DEXMEDETOMIDINE","strength":"180MCG","dosageForm":"FILM;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215390Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-05
        )

)