ANI PHARMS INC FDA Approval ANDA 089602

ANDA 089602

ANI PHARMS INC

FDA Drug Application

Application #089602

Application Sponsors

ANDA 089602ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001CONCENTRATE;ORAL30MG/ML0THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1987-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1992-07-07
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1992-11-17
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1996-05-31
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-06-11
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-03-23
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-06-17

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89602
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"30MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"30MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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