NDA 018226

VALIDUS PHARMS

FDA Drug Application

Application #018226

Documents

• Letter: 2002-10-29
• Letter: 2002-10-29
• Review: 2003-03-07
• Label: 2002-10-29
• Label: 2002-10-29
• Review: 2003-03-07

Application Sponsors

NDA 018226

VALIDUS PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

BUMEX

BUMETANIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1983-02-28	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1984-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-08-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	1985-09-06
LABELING; Labeling	SUPPL	11	AP	1989-01-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-10-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	1991-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-06-11	STANDARD
LABELING; Labeling	SUPPL	18	AP	1993-10-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	1998-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1999-01-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-02-24	STANDARD
LABELING; Labeling	SUPPL	24	AP	2002-10-29	STANDARD
LABELING; Labeling	SUPPL	25	AP	2002-10-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18226
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)