ASCENT PHARMS INC FDA Approval ANDA 212133

ANDA 212133

ASCENT PHARMS INC

FDA Drug Application

Application #212133

Application Sponsors

ANDA 212133ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL8MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL12MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL16MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL32MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212133
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"12MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"16MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"32MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-23
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.