Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021042
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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf | |
| 05/09/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf | |
| 05/09/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf | |
| 08/19/2004 | SUPPL-26 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf | |
| 08/06/2003 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf | |
| 04/11/2002 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf | |
| 04/11/2002 | SUPPL-13 | Labeling | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.htm | ||
| 04/11/2002 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf | |
| 04/11/2002 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf | |
| 04/11/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf | |
| 04/11/2002 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf | |
| 01/10/2001 | SUPPL-9 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf |
| 05/20/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21042lbl.pdf |