Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION;ORAL | 5MG/5ML | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
002 | SOLUTION;ORAL | 10MG/5ML | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-06-30 | |
REMS; REMS | SUPPL | 2 | AP | 2013-04-15 | |
LABELING; Labeling | SUPPL | 3 | AP | 2014-04-16 | STANDARD |
REMS; REMS | SUPPL | 5 | AP | 2014-08-19 | |
REMS; REMS | SUPPL | 6 | AP | 2015-06-26 | |
REMS; REMS | SUPPL | 7 | AP | 2016-04-20 | |
LABELING; Labeling | SUPPL | 8 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2016-12-16 | STANDARD |
REMS; REMS | SUPPL | 10 | AP | 2016-09-30 | |
LABELING; Labeling | SUPPL | 11 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2017-01-23 | STANDARD |
REMS; REMS | SUPPL | 13 | AP | 2017-05-26 | |
LABELING; Labeling | SUPPL | 14 | AP | 2018-01-31 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2018-01-31 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2018-02-01 | STANDARD |
REMS; REMS | SUPPL | 17 | AP | 2018-09-18 | |
LABELING; Labeling | SUPPL | 18 | AP | 2018-09-21 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2019-10-11 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2021-06-02 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 15 |
SUPPL | 10 | Null | 15 |
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 | 17 | Null | 7 |
SUPPL | 18 | Null | 7 |
SUPPL | 23 | Null | 7 |
SUPPL | 24 | Null | 7 |
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 90707
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/16\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/090707Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/090707Orig1s003lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2014-04-16
)
)