Application Sponsors
| ANDA 090065 | EPIC PHARMA LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2015-08-18 | |
| REMS; REMS | SUPPL | 4 | AP | 2016-09-30 | |
| REMS; REMS | SUPPL | 6 | AP | 2017-05-26 | |
| REMS; REMS | SUPPL | 9 | AP | 2018-09-18 | |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
EPIC PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 90065
[companyName] => EPIC PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)