ASCENT PHARMS INC FDA Approval ANDA 207421

ANDA 207421

ASCENT PHARMS INC

FDA Drug Application

Application #207421

Application Sponsors

ANDA 207421ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL2.5MG0DRONABINOLDRONABINOL
002CAPSULE;ORAL5MG0DRONABINOLDRONABINOL
003CAPSULE;ORAL10MG0DRONABINOLDRONABINOL

FDA Submissions

UNKNOWN; ORIG1AP2020-02-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207421
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-07
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.