Application 021647
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIOXX | ROFECOXIB | TABLET; ORAL | 12.5MG | No | No |
| 002 | VIOXX | ROFECOXIB | TABLET; ORAL | 25MG | No | No |
| 003 | VIOXX | ROFECOXIB | TABLET; ORAL | 50MG | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.