Documents
Application Sponsors
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
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
)
)