ANDA 211228

ASCENT PHARMS INC

FDA Drug Application

Application #211228

Application Sponsors

ANDA 211228

ASCENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-06-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211228
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/03\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-03
        )

)