Application Sponsors
Marketing Status
Application Products
001 | TABLET, FOR SUSPENSION;ORAL | 40MG | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2005-07-12 | |
LABELING; Labeling | SUPPL | 2 | AP | 2006-09-20 | |
LABELING; Labeling | SUPPL | 3 | AP | 2006-03-23 | |
LABELING; Labeling | SUPPL | 5 | AP | 2007-04-04 | |
LABELING; Labeling | SUPPL | 6 | AP | 2009-11-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-11-05 | |
LABELING; Labeling | SUPPL | 11 | AP | 2014-12-13 | STANDARD |
REMS; REMS | SUPPL | 17 | AP | 2018-09-18 | |
Submissions Property Types
SUPPL | 6 | Null | 7 |
SUPPL | 8 | Null | 0 |
SUPPL | 11 | Null | 7 |
SUPPL | 17 | Null | 15 |
TE Codes
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 77142
[companyName] => SPECGX LLC
[docInserts] => ["",""]
[products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET, FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)