Drug application
VIOXX (ROFECOXIB)
Drugs@FDA NDA 021647 · MERCK
Key facts
| Drug name | VIOXX |
|---|---|
| Active ingredients | ROFECOXIB |
| Application type | NDA |
| Application number | 021647 |
| Company | MERCK |
| Dosage forms | TABLET, ORAL |
| Strength | 12.5MG |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 6 - New Indication (no longer used) |
| Latest submission status date | Mar 26, 2004 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: