WATSON LABS TEVA FDA Approval ANDA 086179

ANDA 086179

WATSON LABS TEVA

FDA Drug Application

Application #086179

Application Sponsors

ANDA 086179WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL350MG0CARISOPRODOLCARISOPRODOL

FDA Submissions

ORIG1AP1979-06-12
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1986-09-22
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1986-09-22
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1984-10-10
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1987-08-24
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1987-04-16
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1987-08-24
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1987-08-24
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1988-08-22
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1988-08-22
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1988-08-22
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1988-08-22
MANUF (CMC); Manufacturing (CMC)SUPPL28AP1994-02-02
MANUF (CMC); Manufacturing (CMC)SUPPL29AP1994-02-02
LABELING; LabelingSUPPL30AP1992-05-01
MANUF (CMC); Manufacturing (CMC)SUPPL31AP1996-06-06
MANUF (CMC); Manufacturing (CMC)SUPPL32AP1996-06-06
MANUF (CMC); Manufacturing (CMC)SUPPL33AP1997-07-07
MANUF (CMC); Manufacturing (CMC)SUPPL34AP1997-07-07
MANUF (CMC); Manufacturing (CMC)SUPPL35AP1997-07-07

Submissions Property Types

SUPPL8Null0
SUPPL9Null0
SUPPL15Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL27Null0
SUPPL28Null0
SUPPL29Null0
SUPPL31Null0
SUPPL32Null0
SUPPL33Null0
SUPPL34Null0
SUPPL35Null0

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86179
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARISOPRODOL","submission":"CARISOPRODOL","actionType":"350MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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