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Last Updated: March 28, 2024

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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength12.5MG/5ML
Approval Date:May 20, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:May 20, 1999TE:RLD:No

Expired US Patents for NDA 021052

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-001 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-002 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-002 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck VIOXX rofecoxib SUSPENSION;ORAL 021052-001 May 20, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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