Application Sponsors
| ANDA 203502 | AUROLIFE 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
| UNKNOWN; | ORIG | 1 | AP | 2015-08-31 | |
| REMS; REMS | SUPPL | 2 | AP | 2016-09-30 | |
| REMS; REMS | SUPPL | 3 | AP | 2017-05-26 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-02-18 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-06-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 203502
[companyName] => AUROLIFE 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":"08\/31\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-09-18
)
)