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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021052
Company: MERCK

Other Important Information from FDA

Products on NDA 021052

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIOXX	ROFECOXIB	12.5MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No
VIOXX	ROFECOXIB	25MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021052

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 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_appltr.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-24	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-21	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/2004/021052_S021_VIOXX.pdf
08/19/2004	SUPPL-19	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/2004/021052_S019_VIOXX.pdf
12/16/2003	SUPPL-17	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
06/27/2003	SUPPL-16	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-15	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-14	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-12	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-11	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-10	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021052_S010_VIOXX.pdf
04/11/2002	SUPPL-9	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-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-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
04/11/2002	SUPPL-6	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-5	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-4	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
03/17/2000	SUPPL-3	Labeling		Label is not available on this site.
03/02/2000	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/28/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021052

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf
05/09/2016	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf
05/09/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf
08/19/2004	SUPPL-19	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf
08/06/2003	SUPPL-12	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-9	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-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
04/11/2002	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
04/11/2002	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf
04/11/2002	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		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/nda/99/021042_52_vioxx_prntlbl.pdf

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