Application Sponsors
Marketing Status
Application Products
001 | CONCENTRATE;ORAL | 10MG/ML | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1994-11-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-09-27 | |
LABELING; Labeling | SUPPL | 3 | AP | 2002-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2011-10-21 | |
LABELING; Labeling | SUPPL | 10 | AP | 2022-12-14 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2022-12-14 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2022-12-14 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2022-12-14 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2022-12-14 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 8 | Null | 15 |
SUPPL | 10 | Null | 7 |
SUPPL | 11 | Null | 7 |
SUPPL | 15 | Null | 7 |
SUPPL | 18 | Null | 7 |
SUPPL | 20 | Null | 7 |
TE Codes
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 40088
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)