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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 021052

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NDA 021052 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 021052

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	12.5MG/5ML
Approval Date:	May 20, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	May 20, 1999	TE:		RLD:	No

Expired US Patents for NDA 021052

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-002	May 20, 1999	5,474,995*PED	⤷ Get Started Free
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999	5,474,995*PED	⤷ Get Started Free
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-002	May 20, 1999	6,063,811*PED	⤷ Get Started Free
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-002	May 20, 1999	5,691,374*PED	⤷ Get Started Free
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999	6,239,173*PED	⤷ Get Started Free
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999	6,063,811*PED	⤷ Get Started Free
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999	5,691,374*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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