Details for New Drug Application (NDA): 021042

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NDA 021042 describes VIOXX, which is a drug marketed by Merck and is included in two NDAs. Additional details are available on the VIOXX profile page.

The generic ingredient in VIOXX is rofecoxib. There are two drug master file entries for this compound. Additional details are available on the rofecoxib profile page.

Summary for 021042

Tradename:	VIOXX
Applicant:	Merck
Ingredient:	rofecoxib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	May 20, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 20, 1999	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 25, 2000	TE:		RLD:	No

Expired US Patents for NDA 021042

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-003	Feb 25, 2000	⤷ Sign Up	⤷ Sign Up
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999	⤷ Sign Up	⤷ Sign Up
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999	⤷ Sign Up	⤷ Sign Up
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-002	May 20, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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