PAR PHARM FDA Approval ANDA 088934

ANDA 088934

PAR PHARM

FDA Drug Application

Application #088934

Application Sponsors

ANDA 088934PAR PHARM

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL200MG0SULFINPYRAZONESULFINPYRAZONE

FDA Submissions

ORIG1AP1985-09-06
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-09-03
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-09-03
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1988-01-05
LABELING; LabelingSUPPL8AP1989-05-08

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL7Null0
SUPPL8Null0

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88934
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFINPYRAZONE","activeIngredients":"SULFINPYRAZONE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFINPYRAZONE","submission":"SULFINPYRAZONE","actionType":"200MG","submissionClassification":"CAPSULE;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.