WATSON LABS TEVA FDA Approval ANDA 071893

ANDA 071893

WATSON LABS TEVA

FDA Drug Application

Application #071893

Application Sponsors

ANDA 071893WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL250MG0ACETOHEXAMIDEACETOHEXAMIDE

FDA Submissions

ORIG1AP1987-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1991-02-27
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1991-02-27
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-01-28
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-02-27
LABELING; LabelingSUPPL7AP1991-09-09
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1996-10-30

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71893
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETOHEXAMIDE","activeIngredients":"ACETOHEXAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETOHEXAMIDE","submission":"ACETOHEXAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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