PAR PHARM FDA Approval ANDA 089136

ANDA 089136

PAR PHARM

FDA Drug Application

Application #089136

Application Sponsors

ANDA 089136PAR PHARM

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL5MG0METHYCLOTHIAZIDEMETHYCLOTHIAZIDE

FDA Submissions

ORIG1AP1986-02-12
LABELING; LabelingSUPPL4AP1988-05-13
LABELING; LabelingSUPPL5AP1988-12-14
LABELING; LabelingSUPPL6AP1992-01-16
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-04-01

Submissions Property Types

ORIG1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89136
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYCLOTHIAZIDE","activeIngredients":"METHYCLOTHIAZIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYCLOTHIAZIDE","submission":"METHYCLOTHIAZIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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