Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021042
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-Package Insert, Labeling-Medication Guide, 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf
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
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

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