PRINSTON INC FDA Approval ANDA 086989

ANDA 086989

PRINSTON INC

FDA Drug Application

Application #086989

Application Sponsors

ANDA 086989PRINSTON INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0METHOCARBAMOLMETHOCARBAMOL

FDA Submissions

ORIG1AP1979-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-06-19
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1986-06-19
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-11-08
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1988-11-08
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1988-11-08

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0

TE Codes

001PrescriptionAA

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86989
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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