ANDA 210354

ASCENT PHARMS INC

FDA Drug Application

Application #210354

Application Sponsors

ANDA 210354

ASCENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, CHEWABLE;ORAL	2.5MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
002	TABLET, CHEWABLE;ORAL	5MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
003	TABLET, CHEWABLE;ORAL	10MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-06-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210354
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-29
        )

)