WATSON LABS TEVA FDA Approval ANDA 088567

ANDA 088567

WATSON LABS TEVA

FDA Drug Application

Application #088567

Application Sponsors

ANDA 088567WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL25MG0THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1984-05-11
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1985-10-08
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1985-10-08
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1985-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1985-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1985-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1988-05-15
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1987-10-26
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1988-06-09
LABELING; LabelingSUPPL18AP1988-04-22
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1988-06-09
LABELING; LabelingSUPPL20AP1988-07-05
LABELING; LabelingSUPPL21AP1990-09-17
LABELING; LabelingSUPPL22AP1991-02-04
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1997-01-31
LABELING; LabelingSUPPL24AP2015-11-03
LABELING; LabelingSUPPL25AP2017-02-24STANDARD

Submissions Property Types

SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL14Null0
SUPPL16Null0
SUPPL17Null0
SUPPL19Null0
SUPPL23Null0
SUPPL24Null15
SUPPL25Null7

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88567
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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