ANDA 074448

AUROLIFE PHARMA LLC

FDA Drug Application

Application #074448

Application Sponsors

ANDA 074448

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	50MG	0	FLURBIPROFEN	FLURBIPROFEN
002	TABLET;ORAL	100MG	0	FLURBIPROFEN	FLURBIPROFEN

FDA Submissions

	ORIG	1	AP	1995-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-11-20
LABELING; Labeling	SUPPL	3	AP	1999-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-04-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-03-25

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74448
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURBIPROFEN","activeIngredients":"FLURBIPROFEN","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLURBIPROFEN","activeIngredients":"FLURBIPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLURBIPROFEN","submission":"FLURBIPROFEN","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLURBIPROFEN","submission":"FLURBIPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)