Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 500MG | 0 | DISULFIRAM | DISULFIRAM |
FDA Submissions
| ORIG | 1 | AP | 1984-08-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-02-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-01-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-01-09 | |
LABELING; Labeling | SUPPL | 7 | AP | 1989-01-10 | |
LABELING; Labeling | SUPPL | 8 | AP | 2009-04-03 | |
LABELING; Labeling | SUPPL | 9 | AP | 2009-06-04 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
CDER Filings
PAR PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 88793
[companyName] => PAR PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"DISULFIRAM","activeIngredients":"DISULFIRAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DISULFIRAM","submission":"DISULFIRAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)