Documents
Application Sponsors
Marketing Status
Discontinued | 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 | 1998-05-29 | |
LABELING; Labeling | SUPPL | 4 | AP | 2007-02-05 | |
REMS; REMS | SUPPL | 6 | AP | 2012-07-09 | |
LABELING; Labeling | SUPPL | 7 | AP | 2012-07-09 | |
REMS; REMS | SUPPL | 8 | AP | 2013-04-15 | |
LABELING; Labeling | SUPPL | 9 | AP | 2014-12-19 | STANDARD |
REMS; REMS | SUPPL | 11 | AP | 2014-08-19 | |
REMS; REMS | SUPPL | 12 | AP | 2015-06-26 | |
LABELING; Labeling | SUPPL | 13 | AP | 2015-05-29 | STANDARD |
REMS; REMS | SUPPL | 14 | AP | 2016-04-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2016-10-31 | UNKNOWN |
REMS; REMS | SUPPL | 16 | AP | 2016-09-30 | |
REMS; REMS | SUPPL | 18 | AP | 2017-05-26 | |
REMS; REMS | SUPPL | 19 | AP | 2018-09-18 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 7 |
SUPPL | 11 | Null | 15 |
SUPPL | 12 | Null | 7 |
SUPPL | 13 | Null | 7 |
SUPPL | 14 | Null | 7 |
SUPPL | 15 | Null | 15 |
SUPPL | 16 | Null | 15 |
SUPPL | 18 | Null | 15 |
SUPPL | 19 | Null | 15 |
TE Codes
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 40241
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","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":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)