Last Updated: May 20, 2026

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

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