ANDA 089207

PAR PHARM

FDA Drug Application

Application #089207

Application Sponsors

ANDA 089207

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

16MG

0

METHYLPREDNISOLONE

METHYLPREDNISOLONE

FDA Submissions

	ORIG	1	AP	1988-04-25
LABELING; Labeling	SUPPL	2	AP	1995-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-06-07

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89207
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE","actionType":"16MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)