NDA 021042

MERCK

FDA Drug Application

Application #021042

Documents

• Letter: 1999-05-20
• Letter: 2002-04-11
• Letter: 2002-04-11
• Letter: 2002-04-11
• Letter: 2002-04-11
• Letter: 2003-08-15
• Letter: 2003-07-06
• Letter: 2004-08-25
• Letter: 2016-05-11
• Label: 1999-05-20
• Label: 2002-04-11
• Label: 2002-04-11
• Label: 2002-04-11
• Label: 2002-04-11
• Label: 2003-08-15
• Label: 2004-08-19
• Label: 2016-05-11
• Review: 2008-08-04
• Review: 2002-04-11
• Review: 2002-04-11
• Review: 2002-04-11
• Review: 2008-08-04
• Review: 2002-04-11
• Review: 2008-08-01
• Review: 2008-08-01
• Review: 2006-06-01
• Review: 2006-06-01
• Review: 2006-06-01
• Review: 2006-06-01
• Review: 2008-07-31
• Review: 2008-07-31
• Letter: 2002-04-11
• Letter: 2002-04-11
• Letter: 2002-04-11
• Letter: 2003-07-06
• Letter: 2003-07-06
• Letter: 2003-12-19
• Letter: 2003-12-19
• Letter: 2004-09-16
• Label: 2002-04-11
• Label: 2002-04-11
• Label: 2002-04-11
• Review: 1999-05-20
• Review: 2008-08-04
• Review: 2008-08-04
• Review: 2002-04-11
• Review: 2002-04-11
• Review: 2002-04-11
• Review: 2006-06-01
• Review: 2006-06-01
• Other Important Information from FDA: 2004-09-30
• Other: 2004-09-30
• Pediatric Medical Review: 1900-01-01
• Pediatric DD Summary Review: 1900-01-01
• Pediatric DD Summary Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Amendment 2: 1900-01-01

Application Sponsors

NDA 021042

MERCK

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	12.5MG	0	VIOXX	ROFECOXIB
002	TABLET;ORAL	25MG	0	VIOXX	ROFECOXIB
003	TABLET;ORAL	50MG	0	VIOXX	ROFECOXIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-05-20	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1999-10-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-03-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-08-10	PRIORITY
EFFICACY; Efficacy	SUPPL	7	AP	2002-04-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-01-10	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2002-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-06-13	PRIORITY
EFFICACY; Efficacy	SUPPL	12	AP	2002-04-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	2002-04-11	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-04-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-06-25	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2003-05-19	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2003-08-06	STANDARD
LABELING; Labeling	SUPPL	20	AP	2003-06-27	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-06-27	STANDARD
LABELING; Labeling	SUPPL	22	AP	2003-06-27	STANDARD
LABELING; Labeling	SUPPL	23	AP	2003-12-16	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-12-16	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	2004-08-19	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2004-09-14	STANDARD
LABELING; Labeling	SUPPL	33	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	21	Null	9
SUPPL	22	Null	9
SUPPL	26	Null	6
SUPPL	33	Null	7

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 21042
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)