ASCENT PHARMS INC FDA Approval ANDA 210354

ANDA 210354

ASCENT PHARMS INC

FDA Drug Application

Application #210354

Application Sponsors

ANDA 210354ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, CHEWABLE;ORAL2.5MG0METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
002TABLET, CHEWABLE;ORAL5MG0METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
003TABLET, CHEWABLE;ORAL10MG0METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-12-29STANDARD
LABELING; LabelingSUPPL3AP2021-06-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

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
        )

)

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