NDA 214517

VANDA PHARMACEUTICALS INC

FDA Drug Application

Application #214517

Documents

• Label: 2020-12-02
• Letter: 2020-12-02
• Review: 2021-07-19

Application Sponsors

NDA 214517

VANDA PHARMACEUTICALS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	20MG	2	HETLIOZ	TASIMELTEON
002	SUSPENSION;ORAL	4MG/ML	2	HETLIOZ LQ	TASIMELTEON

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2020-12-01

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

VANDA PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214517
            [companyName] => VANDA PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HETLIOZ","activeIngredients":"TASIMELTEON","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"HETLIOZ LQ","activeIngredients":"TASIMELTEON","strength":"4MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214517s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214517s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214517Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-12-01
        )

)