ASCENT PHARMS INC FDA Approval ANDA 210175

ANDA 210175

ASCENT PHARMS INC

FDA Drug Application

Application #210175

Application Sponsors

ANDA 210175ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
002TABLET;ORAL10MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-02-02STANDARD
REMS; REMSSUPPL2AP2018-09-18
LABELING; LabelingSUPPL3AP2021-02-08STANDARD
LABELING; LabelingSUPPL4AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL3Null15
SUPPL4Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210175
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)

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