ANDA 071525

PLIVA

FDA Drug Application

Application #071525

Application Sponsors

ANDA 071525

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG

0

TRAZODONE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-03-09
LABELING; Labeling	SUPPL	2	AP	1988-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-09-20
LABELING; Labeling	SUPPL	5	AP	1991-12-16
LABELING; Labeling	SUPPL	6	AP	1992-04-30
LABELING; Labeling	SUPPL	7	AP	1993-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-05-11
LABELING; Labeling	SUPPL	9	AP	1994-01-11
LABELING; Labeling	SUPPL	10	AP	1995-04-21
LABELING; Labeling	SUPPL	11	AP	1996-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-10-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-07-07
LABELING; Labeling	SUPPL	17	AP	2000-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-03-30
LABELING; Labeling	SUPPL	23	AP	2002-11-12
LABELING; Labeling	SUPPL	26	AP	2005-07-08
LABELING; Labeling	SUPPL	27	AP	2005-11-29
LABELING; Labeling	SUPPL	37	AP	2007-06-25
LABELING; Labeling	SUPPL	40	AP	2008-08-13
LABELING; Labeling	SUPPL	43	AP	2009-07-08
LABELING; Labeling	SUPPL	53	AP	2014-07-01	STANDARD
LABELING; Labeling	SUPPL	54	AP	2014-07-11	STANDARD
LABELING; Labeling	SUPPL	55	AP	2014-07-18	STANDARD
LABELING; Labeling	SUPPL	63	AP	2022-11-09	STANDARD
LABELING; Labeling	SUPPL	72	AP	2022-11-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	53	Null	7
SUPPL	54	Null	7
SUPPL	55	Null	15
SUPPL	63	Null	7
SUPPL	72	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71525
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)