PLIVA FDA Approval ANDA 062646

ANDA 062646

PLIVA

FDA Drug Application

Application #062646

Application Sponsors

ANDA 062646PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL330MG0ULTRAGRIS-330GRISEOFULVIN, ULTRAMICROCRYSTALLINE

FDA Submissions

ORIG1AP1992-06-30
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2000-07-07

Submissions Property Types

ORIG1Null0
SUPPL2Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62646
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRAGRIS-330","activeIngredients":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","strength":"330MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ULTRAGRIS-330","submission":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","actionType":"330MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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