ANDA 080780

IMPAX LABS

FDA Drug Application

Application #080780

Application Sponsors

ANDA 080780

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG

0

PREDNISOLONE

PREDNISOLONE

FDA Submissions

	ORIG	1	AP	1973-07-13
LABELING; Labeling	SUPPL	39	AP	2001-03-16
LABELING; Labeling	SUPPL	40	AP	1989-12-13
LABELING; Labeling	SUPPL	41	AP	1991-10-28
LABELING; Labeling	SUPPL	42	AP	1991-10-28
LABELING; Labeling	SUPPL	43	AP	1996-10-18

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80780
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE","activeIngredients":"PREDNISOLONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISOLONE","submission":"PREDNISOLONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)