WATSON LABS INC FDA Approval ANDA 088337

ANDA 088337

WATSON LABS INC

FDA Drug Application

Application #088337

Application Sponsors

ANDA 088337WATSON LABS INC

Marketing Status

Discontinued001

Application Products

001TABLET;SUBLINGUAL2MG0ERGOSTATERGOTAMINE TARTRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-07-09
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1987-07-09
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1989-01-19
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1989-01-19
LABELING; LabelingSUPPL10AP1988-09-26
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1991-06-14

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL8Null0
SUPPL9Null0
SUPPL12Null0

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88337
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERGOSTAT","activeIngredients":"ERGOTAMINE TARTRATE","strength":"2MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERGOSTAT","submission":"ERGOTAMINE TARTRATE","actionType":"2MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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