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 | 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 | 2010-06-14 | |
| ORIG | 2 | AP | 2010-07-22 | |
| ORIG | 3 | AP | 2010-12-21 | |
| REMS; REMS | SUPPL | 4 | AP | 2012-10-12 | |
| REMS; REMS | SUPPL | 5 | AP | 2012-10-12 | |
| REMS; REMS | SUPPL | 6 | AP | 2013-04-15 | |
| LABELING; Labeling | SUPPL | 12 | AP | 2014-04-16 | STANDARD |
| REMS; REMS | SUPPL | 17 | AP | 2014-08-19 | |
| REMS; REMS | SUPPL | 18 | AP | 2015-06-26 | |
| REMS; REMS | SUPPL | 20 | AP | 2016-04-20 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2016-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 26 | AP | 2016-09-30 | |
| LABELING; Labeling | SUPPL | 27 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2018-09-28 | STANDARD |
| REMS; REMS | SUPPL | 29 | AP | 2017-05-26 | |
| REMS; REMS | SUPPL | 32 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2018-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2019-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| ORIG | 2 | Null | 42 |
| ORIG | 3 | Null | 42 |
| SUPPL | 4 | Null | 19 |
| SUPPL | 5 | Null | 19 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 42 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
IMPAX LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 79087
[companyName] => IMPAX LABS
[docInserts] => ["",""]
[products] => [{"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"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"7.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYMORPHONE HYDROCHLORIDE","submission":"OXYMORPHONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)