PAR PHARM FDA Approval ANDA 089657

ANDA 089657

PAR PHARM

FDA Drug Application

Application #089657

Application Sponsors

ANDA 089657PAR PHARM

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL325MG;400MG0METHOCARBAMOL AND ASPIRINASPIRIN; METHOCARBAMOL

FDA Submissions

ORIG1AP1988-11-04
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1989-05-19
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1989-05-19
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1997-11-26

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89657
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL AND ASPIRIN","activeIngredients":"ASPIRIN; METHOCARBAMOL","strength":"325MG;400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL AND ASPIRIN","submission":"ASPIRIN; METHOCARBAMOL","actionType":"325MG;400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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