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FDA Drug Application 021042 by MERCK

Application Number021042
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/20/1999N1019000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21042ltr.pdf 5/20/1999
AP05/20/1999N1020000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_Vioxx.cfm 5/20/1999
AP05/20/1999N1021000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21042lbl.pdf 5/20/1999
AP05/20/1999N10316000FDA Public Health Advisory  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm 9/30/2004
AP05/20/1999N10319000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 9/30/2004
AP02/25/2000SCS20475001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S001_VIOXX.pdf 8/4/2008
AP010/28/1999SLR20496002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_S002_VIOXX.pdf 8/4/2008
AP03/17/2000SLR       
AP03/7/2000SCS20474004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021042_S004_VIOXX.pdf 8/4/2008
AP08/10/2000SCM       
AP04/11/2002SE82706007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SE82707007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SE82708007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR2709008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SLR2710008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SLR2711008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP01/10/2001SCS2737009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP01/10/2001SCS2738009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP01/10/2001SCS2739009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR2712010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SLR2713010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SLR2714010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP06/13/2001SCS20456011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021042_S011_VIOXX.pdf 8/4/2008
AP04/11/2002SE12715012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SE12716012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SE12717012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR2718013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SLR2719013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.htm 4/11/2002
AP04/11/2002SLR2720013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR2721014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SLR2722014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SLR2723014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/6/2002SCM20418015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S015_VIOXX.pdf 8/1/2008
AP06/25/2002SCM20417016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021042_S016_VIOXX.pdf 8/1/2008
AP05/19/2003SLR14202017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s017_021052_s011_VioxxTOC.cfm 6/1/2006
AP08/6/2003SE86502018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf 8/15/2003
AP08/6/2003SE86525018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042se8-018,21052se8-012ltr.pdf 8/15/2003
AP06/27/2003SLR6061020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf 7/6/2003
AP06/27/2003SLR14204020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm 6/1/2006
AP06/27/2003SLR14205021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm 6/1/2006
AP06/27/2003SLR6062021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf 7/6/2003
AP06/27/2003SLR6063022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf 7/6/2003
AP06/27/2003SLR14206022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm 6/1/2006
AP012/16/2003SLR14210023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s023_VioxxtmTOC.cfm 6/1/2006
AP012/16/2003SLR7285023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042slr023ltr.pdf 12/19/2003
AP012/16/2003SLR7287024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr024ltr.pdf 12/19/2003
AP012/16/2003SLR14211024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s024_021052_s017_VioxxtmTOC.cfm 6/1/2006
AP08/19/2004SE510025026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf 8/19/2004
AP08/19/2004SE510043026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21052s019,026ltr.pdf 8/25/2004
AP08/19/2004SE520367026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S026_VIOXX.pdf 7/31/2008
AP09/14/2004SLR10215028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21042s028,21052s021ltr.pdf 9/16/2004
AP09/14/2004SLR20366028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021042_S028_VIOXX.pdf 7/31/2008
AP05/9/2016SLR45916033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021042Orig1s033,021052Orig1s024ltr.pdf 5/11/2016
AP05/9/2016SLR45984033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf 5/11/2016




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