Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
| Prescription | 007 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 40MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 5MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 7.5MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | 10MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 005 | TABLET, EXTENDED RELEASE;ORAL | 15MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 006 | TABLET, EXTENDED RELEASE;ORAL | 20MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 007 | TABLET, EXTENDED RELEASE;ORAL | 30MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-07-15 | |
| REMS; REMS | SUPPL | 3 | AP | 2014-08-19 | |
| REMS; REMS | SUPPL | 4 | AP | 2015-06-26 | |
| REMS; REMS | SUPPL | 6 | AP | 2016-04-20 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2017-03-10 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 2016-09-30 | |
| REMS; REMS | SUPPL | 11 | AP | 2017-05-26 | |
| REMS; REMS | SUPPL | 12 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2018-09-21 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
| 007 | Prescription | AB |
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 200822
[companyName] => HIKMA
[docInserts] => ["",""]
[products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2013\\\/200822Orig1s000.Approv.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/09\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-12","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-11","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-10","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/10\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/10\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2014","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/16\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-09
)
)