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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/20/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_Vioxx.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/09/2016 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021042Orig1s033,021052Orig1s024ltr.pdf | |
| 09/14/2004 | SUPPL-28 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21042s028,21052s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S028_VIOXX.pdf |
| 08/19/2004 | SUPPL-26 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21052s019,026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S026_VIOXX.pdf | |
| 12/16/2003 | SUPPL-24 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s024_021052_s017_VioxxtmTOC.cfm |
| 12/16/2003 | SUPPL-23 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042slr023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s023_VioxxtmTOC.cfm |
| 06/27/2003 | SUPPL-22 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm |
| 06/27/2003 | SUPPL-21 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm |
| 06/27/2003 | SUPPL-20 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm |
| 08/06/2003 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042se8-018,21052se8-012ltr.pdf | |
| 05/19/2003 | SUPPL-17 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s017_021052_s011_VioxxTOC.cfm |
| 06/25/2002 | SUPPL-16 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S016_VIOXX.pdf |
| 04/06/2002 | SUPPL-15 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S015_VIOXX.pdf |
| 04/11/2002 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 04/11/2002 | SUPPL-13 | Labeling |
Label
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 04/11/2002 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 06/13/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021042_S011_VIOXX.pdf |
| 04/11/2002 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 01/10/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 04/11/2002 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 04/11/2002 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm | |
| 08/10/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S004_VIOXX.pdf |
| 03/17/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_S002_VIOXX.pdf |
| 02/25/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S001_VIOXX.pdf |
| 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 |