NDA 018413

AVET

FDA Drug Application

Application #018413

Application Sponsors

NDA 018413

AVET

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	20MG	0	FUROSEMIDE	FUROSEMIDE
002	TABLET;ORAL	40MG	0	FUROSEMIDE	FUROSEMIDE

FDA Submissions

	ORIG	1	AP	1983-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-04-25
LABELING; Labeling	SUPPL	13	AP	1988-08-05
LABELING; Labeling	SUPPL	15	AP	1991-06-25
LABELING; Labeling	SUPPL	16	AP	1992-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1992-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-10-27
LABELING; Labeling	SUPPL	20	AP	1992-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1997-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1999-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1999-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1999-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1999-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1999-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1999-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2000-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2000-01-28
LABELING; Labeling	SUPPL	34	AP	2000-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2001-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2001-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2002-07-29
LABELING; Labeling	SUPPL	49	AP	2009-02-06
LABELING; Labeling	SUPPL	51	AP	2009-02-06
LABELING; Labeling	SUPPL	54	AP	2009-03-12
LABELING; Labeling	SUPPL	58	AP	2010-12-27
LABELING; Labeling	SUPPL	60	AP	2012-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2015-08-07

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	60	Null	15
SUPPL	62	Null	0

CDER Filings

AVET

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18413
            [companyName] => AVET
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)