ANDA 072484

AUROLIFE PHARMA LLC

FDA Drug Application

Application #072484

Application Sponsors

ANDA 072484

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAZODONE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1990-04-30
LABELING; Labeling	SUPPL	2	AP	1992-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-04-26
LABELING; Labeling	SUPPL	4	AP	1996-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-05-05
LABELING; Labeling	SUPPL	8	AP	1999-09-10
LABELING; Labeling	SUPPL	9	AP	2000-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-05-09
LABELING; Labeling	SUPPL	14	AP	2014-07-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	7

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72484
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)