ASCENT PHARMS INC FDA Approval ANDA 215414

ANDA 215414

ASCENT PHARMS INC

FDA Drug Application

Application #215414

Application Sponsors

ANDA 215414ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL25MG0TOPIRAMATETOPIRAMATE
002TABLET;ORAL50MG0TOPIRAMATETOPIRAMATE
003TABLET;ORAL100MG0TOPIRAMATETOPIRAMATE
004TABLET;ORAL200MG0TOPIRAMATETOPIRAMATE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215414
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-26
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.