PAR PHARM FDA Approval ANDA 200792

ANDA 200792

PAR PHARM

FDA Drug Application

Application #200792

Documents

Letter2014-10-28
Other2015-06-30

Application Sponsors

ANDA 200792PAR PHARM

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006
Discontinued007

Application Products

001TABLET, EXTENDED RELEASE;ORAL5MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL7.5MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL10MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL15MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORAL20MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
006TABLET, EXTENDED RELEASE;ORAL30MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE
007TABLET, EXTENDED RELEASE;ORAL40MG0OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDE

FDA Submissions

ORIG1AP2014-10-24
REMS; REMSSUPPL2AP2016-04-20

Submissions Property Types

ORIG1Null1
SUPPL2Null15

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200792
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/24\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200792Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/20\/2016","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-04-20
        )

)

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