Application Sponsors
| ANDA 201187 | EPIC PHARMA LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG | 0 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2014-12-15 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-02-16 | STANDARD |
| REMS; REMS | SUPPL | 4 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 31 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 10 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
EPIC PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 201187
[companyName] => EPIC PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/15\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-4","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-09-18
)
)