ANI PHARMS INC FDA Approval ANDA 088273

ANDA 088273

ANI PHARMS INC

FDA Drug Application

Application #088273

Application Sponsors

ANDA 088273ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL100MG0THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1983-10-03
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1983-12-12
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1984-01-17
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1984-01-17
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1986-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1986-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1986-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1987-07-16
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1987-07-16

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88273
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"100MG","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.