NDA 017911

MERCK

FDA Drug Application

Application #017911

Documents

• Letter: 2006-10-13
• Letter: 2006-01-30
• Letter: 2007-08-27
• Letter: 2010-12-28
• Label: 2006-01-25
• Label: 2007-08-27
• Label: 2010-06-07
• Letter: 2009-04-03
• Letter: 2010-06-10
• Label: 2006-10-11
• Label: 2009-04-03
• Label: 2010-12-26
• Medication Guide: 2009-11-16

Application Sponsors

NDA 017911

MERCK

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CLINORIL	SULINDAC
002	TABLET;ORAL	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CLINORIL	SULINDAC

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-07-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	1979-08-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	1979-08-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	1981-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1981-12-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	1981-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1981-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-11-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	1982-06-29	STANDARD
LABELING; Labeling	SUPPL	18	AP	1982-06-22	STANDARD
LABELING; Labeling	SUPPL	20	AP	1982-06-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1984-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1984-08-13	STANDARD
LABELING; Labeling	SUPPL	27	AP	1989-05-31	STANDARD
LABELING; Labeling	SUPPL	31	AP	1984-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1984-07-26	STANDARD
LABELING; Labeling	SUPPL	34	AP	1984-11-26	STANDARD
LABELING; Labeling	SUPPL	35	AP	1986-02-05	STANDARD
LABELING; Labeling	SUPPL	37	AP	1986-02-05	STANDARD
LABELING; Labeling	SUPPL	38	AP	1986-02-05	STANDARD
LABELING; Labeling	SUPPL	40	AP	1989-01-09	STANDARD
LABELING; Labeling	SUPPL	43	AP	1989-01-09	STANDARD
LABELING; Labeling	SUPPL	44	AP	1989-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1988-05-03	STANDARD
LABELING; Labeling	SUPPL	46	AP	1989-01-09	STANDARD
LABELING; Labeling	SUPPL	47	AP	1989-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1989-02-06	STANDARD
LABELING; Labeling	SUPPL	50	AP	1989-01-09	STANDARD
LABELING; Labeling	SUPPL	51	AP	1989-05-31	STANDARD
LABELING; Labeling	SUPPL	52	AP	1989-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1992-07-27	STANDARD
LABELING; Labeling	SUPPL	57	AP	1995-06-01	STANDARD
LABELING; Labeling	SUPPL	58	AP	1995-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1994-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1994-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1996-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1997-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1997-04-14	STANDARD
LABELING; Labeling	SUPPL	65	AP	2006-10-05	STANDARD
LABELING; Labeling	SUPPL	66	AP	2001-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	2001-02-07	STANDARD
LABELING; Labeling	SUPPL	68	AP	2006-01-24	STANDARD
LABELING; Labeling	SUPPL	70	AP	2007-08-23	STANDARD
LABELING; Labeling	SUPPL	72	AP	2009-03-30	STANDARD
LABELING; Labeling	SUPPL	73	AP	2010-06-04	STANDARD
LABELING; Labeling	SUPPL	74	AP	2010-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	40	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	55	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	70	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17911
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)