Orange Book product · Brand (NDA)
VIOXX
ROFECOXIB
Brand (NDA)NDA 021052DISCN MERCK
At a glance
May 20, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 1999
27 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ROFECOXIB
Strength
12.5MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 021052
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
