ANDA 062645

PLIVA

FDA Drug Application

Application #062645

Application Sponsors

ANDA 062645

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

165MG

0

ULTRAGRIS-165

GRISEOFULVIN, ULTRAMICROCRYSTALLINE

FDA Submissions

	ORIG	1	AP	1992-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62645
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRAGRIS-165","activeIngredients":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","strength":"165MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ULTRAGRIS-165","submission":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","actionType":"165MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)