ANDA 200792

PAR PHARM

FDA Drug Application

Application #200792

Documents

• Letter: 2014-10-28
• Other: 2015-06-30

Application Sponsors

ANDA 200792

PAR PHARM

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 007

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	7.5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	10MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	15MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	20MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	30MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	40MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2014-10-24
REMS; REMS	SUPPL	2	AP	2016-04-20

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15

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
        )

)