ASCENT PHARMS INC FDA Approval ANDA 209021

ANDA 209021

ASCENT PHARMS INC

FDA Drug Application

Application #209021

Documents

Letter2017-11-15

Application Sponsors

ANDA 209021ASCENT PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;ORAL5MG/5ML0OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
002SOLUTION;ORAL100MG/5ML0OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-11-09STANDARD
REMS; REMSSUPPL2AP2018-09-18

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

ASCENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209021
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209021Orig1s000ltr.pdf\"}]","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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