ANDA 071636

ALVOGEN

FDA Drug Application

Application #071636

Application Sponsors

ANDA 071636

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAZODONE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-04-18
LABELING; Labeling	SUPPL	2	AP	1991-10-22
LABELING; Labeling	SUPPL	3	AP	1991-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-04-28
LABELING; Labeling	SUPPL	5	AP	1995-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-01-18
LABELING; Labeling	SUPPL	7	AP	1995-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-09-12
LABELING; Labeling	SUPPL	13	AP	2000-09-12
LABELING; Labeling	SUPPL	14	AP	2000-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-11-02
LABELING; Labeling	SUPPL	16	AP	2002-10-31
LABELING; Labeling	SUPPL	21	AP	2005-01-06
LABELING; Labeling	SUPPL	23	AP	2005-08-15
LABELING; Labeling	SUPPL	29	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	30	AP	2020-06-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	29	Null	15
SUPPL	30	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71636
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAZODONE HYDROCHLORIDE","activeIngredients":"TRAZODONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAZODONE HYDROCHLORIDE","submission":"TRAZODONE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)