PAR PHARM FDA Approval ANDA 088793

ANDA 088793

PAR PHARM

FDA Drug Application

Application #088793

Application Sponsors

ANDA 088793PAR PHARM

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG0DISULFIRAMDISULFIRAM

FDA Submissions

ORIG1AP1984-08-14
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1987-02-10
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-01-09
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1987-01-09
LABELING; LabelingSUPPL7AP1989-01-10
LABELING; LabelingSUPPL8AP2009-04-03
LABELING; LabelingSUPPL9AP2009-06-04

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.