NDA 018445

MERCK

FDA Drug Application

Application #018445

Documents

• Letter: 2007-03-23
• Label: 2007-03-23
• Letter: 2006-01-30
• Label: 2006-01-25

Application Sponsors

NDA 018445

MERCK

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DOLOBID	DIFLUNISAL
002	TABLET;ORAL	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DOLOBID	DIFLUNISAL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-04-19	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1983-10-27	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1983-10-27	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1985-01-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1984-06-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-05-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-12-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-11-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-02-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1985-02-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1985-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1986-02-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1989-04-21	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1988-02-02	PRIORITY
LABELING; Labeling	SUPPL	25	AP	1986-08-15	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1986-08-15	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1988-02-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1994-03-28	PRIORITY
LABELING; Labeling	SUPPL	30	AP	1988-02-02	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1988-02-02	PRIORITY
LABELING; Labeling	SUPPL	32	AP	1988-02-02	PRIORITY
LABELING; Labeling	SUPPL	33	AP	1988-02-02	PRIORITY
LABELING; Labeling	SUPPL	34	AP	1988-02-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1988-05-03	PRIORITY
LABELING; Labeling	SUPPL	36	AP	1989-01-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1989-04-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1989-01-09	PRIORITY
LABELING; Labeling	SUPPL	40	AP	1989-01-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1991-11-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1991-12-06	PRIORITY
LABELING; Labeling	SUPPL	44	AP	1991-12-06	PRIORITY
LABELING; Labeling	SUPPL	46	AP	1994-08-22	PRIORITY
LABELING; Labeling	SUPPL	47	AP	1994-08-22	PRIORITY
LABELING; Labeling	SUPPL	48	AP	1994-08-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1994-08-18	PRIORITY
LABELING; Labeling	SUPPL	50	AP	1997-04-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1996-03-01	PRIORITY
LABELING; Labeling	SUPPL	52	AP	1998-05-15	PRIORITY
LABELING; Labeling	SUPPL	53	AP	1998-05-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1997-12-01	PRIORITY
LABELING; Labeling	SUPPL	57	AP	2006-01-24	PRIORITY
LABELING; Labeling	SUPPL	58	AP	2007-03-16	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18445
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)