ANI PHARMS INC FDA Approval ANDA 088194

ANDA 088194

ANI PHARMS INC

FDA Drug Application

Application #088194

Application Sponsors

ANDA 088194ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1983-04-14
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1983-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1984-01-17
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1984-01-17
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1984-01-17
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1986-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1986-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1986-11-07

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88194
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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