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FDA Drug Application 021052 by MERCK

Application Number021052
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/20/1999N1044000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_Vioxx.cfm 5/20/1999
AP05/20/1999N10317000FDA Public Health Advisory  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm 9/30/2004
AP05/20/1999N10318000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 9/30/2004
AP05/20/1999N5199000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_appltr.pdf 5/20/1999
AP05/20/1999N5200000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_vioxx_prntlbl.pdf 5/20/1999
AP010/28/1999SLR       
AP03/2/2000SCE       
AP03/17/2000SLR       
AP04/11/2002SE82724004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SE82725004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SE82727004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR2728005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SLR2729005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SLR2730005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR2731006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SLR2732006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SLR2733006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SE12734007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 4/11/2002
AP04/11/2002SE12735007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 4/11/2002
AP04/11/2002SE12736007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 4/11/2002
AP04/11/2002SLR9623008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 6/30/2004
AP04/11/2002SLR9624008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 6/30/2004
AP04/11/2002SLR9625008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 6/30/2004
AP04/11/2002SLR9626009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-042s007_Vioxx.cfm 6/30/2004
AP04/11/2002SLR9627009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21042s7s8s10s12s13s14ltr.pdf 6/30/2004
AP04/11/2002SLR9628009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf 6/30/2004
AP06/25/2002SCM20416010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021052_S010_VIOXX.pdf 8/1/2008
AP05/19/2003SLR14203011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s017_021052_s011_VioxxTOC.cfm 6/1/2006
AP08/6/2003SE86503012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf 8/15/2003
AP08/6/2003SE86526012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21042se8-018,21052se8-012ltr.pdf 8/15/2003
AP06/27/2003SLR6058014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf 7/6/2003
AP06/27/2003SLR14207014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm 6/1/2006
AP06/27/2003SLR14208015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm 6/1/2006
AP06/27/2003SLR6059015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf 7/6/2003
AP06/27/2003SLR6060016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr014,015,016,21042slr020,021,022ltr.pdf 7/6/2003
AP06/27/2003SLR14209016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s020s021s022_021052_s014s015s016_VioxxTOC.cfm 6/1/2006
AP012/16/2003SLR14212017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021042_s024_021052_s017_VioxxtmTOC.cfm 6/1/2006
AP012/16/2003SLR7286017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21052slr017,21042slr024ltr.pdf 12/19/2003
AP08/19/2004SE510024019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf 8/19/2004
AP08/19/2004SE510042019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21052s019,026ltr.pdf 8/25/2004
AP08/19/2004SE520365019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021052_S019_VIOXX.pdf 7/31/2008
AP09/14/2004SLR10216021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21042s028,21052s021ltr.pdf 9/16/2004
AP09/14/2004SLR20364021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021052_S021_VIOXX.pdf 7/31/2008
AP05/9/2016SLR45917024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021042Orig1s033,021052Orig1s024ltr.pdf 5/11/2016
AP05/9/2016SLR45985024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf 5/11/2016




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