Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021647
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIOXX | ROFECOXIB | 12.5MG | TABLET; ORAL | Discontinued | None | No | No |
| VIOXX | ROFECOXIB | 25MG | TABLET; ORAL | Discontinued | None | No | No |
| VIOXX | ROFECOXIB | 50MG | TABLET; ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/26/2004 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21647_vioxx_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21647ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021647_000_VioxxTOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/26/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21647_vioxx_lbl.pdf |