NDA 021647

MERCK

FDA Drug Application

Application #021647

Documents

• Other: 2004-09-30
• Letter: 2004-03-28
• Label: 2004-04-05
• Review: 2005-12-16
• Other Important Information from FDA: 2004-09-30

Application Sponsors

NDA 021647

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 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2004-03-26

STANDARD

CDER Filings

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

)