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FDA Drug Application 020685 by MERCK SHARP DOHME

Application Number020685
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP03/13/1996N       
AP08/22/1996SCM       
AP01/17/1997SCS       
AP012/5/1996SCE       
AP04/3/1997SCS       
AP02/19/1997SLR3675005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020685_s005ap.pdf 2/19/1997
AP03/24/1997SLR       
AP04/16/1997SCS       
AP11/1/1900SLR       
AP29/26/1997SLR       
AP11/1/1900SLR       
AP29/26/1997SLR       
AP011/21/1997SLR       
AP11/1/1900SLR       
AP29/26/1997SLR       
AP08/12/1997SCE       
AP09/26/1997SCS       
AP01/15/1998SCS       
AP010/1/1997SLR       
AP02/6/1998SE7       
AP02/6/1998SLR       
AP02/6/1998SLR       
AP011/18/1997SLR       
AP01/15/1998SCS       
AP06/12/1998SCS       
AP012/17/1998SCF995022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020685s022.pdf 12/17/1998
AP06/4/1999SLR       
AP012/2/1998SCP       
AP06/4/1999SLR       
AP06/4/1999SLR       
AP06/4/1999SLR       
AP06/4/1999SLR       
AP02/23/1999SCS       
AP010/23/2000SLR       
AP06/4/1999SLR       
AP06/4/1999SLR       
AP03/12/1999SCP       
AP06/4/1999SLR       
AP04/11/2000SLR       
AP06/4/1999SLR       
AP04/11/2000SLR       
AP010/25/1999SCE       
AP010/23/2000SLR       
AP03/21/2001SLR1412041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20685s41ltr.pdf 3/21/2001
AP03/21/2001SLR5480041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20685s041.pdf 4/25/2003
AP04/11/2000SLR       
AP010/23/2000SE88534043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-685-S043.pdf 5/6/2004
AP04/19/2000SCF18100044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020685_S044_Crixivan.pdf 9/26/2007
AP010/23/2000SLR       
AP05/7/2004SLR18099046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S046_Crixivan.pdf 9/26/2007
AP05/7/2004SLR8559046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr046,047ltr.pdf 5/7/2004
AP05/7/2004SLR8565046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf 5/7/2004
AP05/7/2004SLR8566047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr046,047_crixivan_lbl.pdf 5/7/2004
AP05/7/2004SLR8560047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr046,047ltr.pdf 5/7/2004
AP05/7/2004SLR18098047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S047_Crixivan.pdf 9/26/2007
AP07/10/2001SCP       
AP06/1/2001SCM       
AP01/25/2002SLR2621050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf 6/20/2002
AP01/25/2002SLR2616050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s50s53ltr.pdf 1/25/2002
AP07/13/2001SCS       
AP09/24/2001SCS18097052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020685_S052_Crixivan.pdf 9/26/2007
AP01/25/2002SLR2617053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s050,053,056LTR.pdf 6/20/2002
AP01/25/2002SLR2620053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf 6/20/2002
AP010/26/2001SCM18096054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020685_S054_Crixivan.pdf 9/26/2007
AP09/19/2002SLR2614055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s55lbl.pdf 9/19/2002
AP09/19/2002SLR2615055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685slr055ltr.pdf 9/19/2002
AP06/20/2002SLR2618056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20685s050,053,056LTR.pdf 6/20/2002
AP06/20/2002SLR2619056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20685s050s053s056lbl.pdf 6/20/2002
AP06/9/2003SLR5962057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20685slr057ltr.pdf 6/22/2003
AP06/9/2003SLR5998057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20685slr057_crixivan_lbl.pdf 6/22/2003
AP01/12/2004SLR7541058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685slr058ltr.pdf 1/14/2004
AP01/12/2004SLR7553058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685slr058_crixivan_lbl.pdf 1/15/2004
AP012/23/2004SLR10818060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20685s060ltr.pdf 12/29/2004
AP012/23/2004SLR10836060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20685s060lbl.pdf 12/29/2004
AP012/23/2004SLR18095060   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020685_S060_Crixivan.pdf 9/26/2007
AP01/12/2006SLR13390061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s061lbl.pdf 1/13/2006
AP01/12/2006SLR13456061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s061ltr.pdf 1/20/2006
AP08/7/2006SLR14642062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s062lbl.pdf 8/9/2006
AP08/7/2006SLR14672062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s062LTR.pdf 8/11/2006
AP012/8/2006SLR15464063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020685s063lbl.pdf 12/14/2006
AP012/8/2006SLR15564063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020685s063ltr.pdf 12/28/2006
AP07/18/2007SLR17336064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020685s064ltr.pdf 7/24/2007
AP07/18/2007SLR17355064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020685s064lbl.pdf 7/24/2007
AP04/16/2008SLR19713065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s065lbl.pdf 4/23/2008
AP04/16/2008SLR19679065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s065ltr.pdf 4/18/2008
AP04/17/2008SLR19683066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s066ltr.pdf 4/22/2008
AP04/17/2008SLR19929066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s066lbl.pdf 6/5/2008
AP012/10/2008SLR21359068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020685s068ltr.pdf 12/18/2008
AP012/10/2008SLR21487068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020685s068lbl.pdf 1/2/2009
AP010/15/2009SLR23663069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020685s069lbl.pdf 10/21/2009
AP010/15/2009SLR23987069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020685s069ltr.pdf 11/19/2009
AP04/26/2010SLR25351071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020685s071ltr.pdf 4/28/2010
AP04/26/2010SLR25413071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s071lbl.pdf 5/3/2010
AP06/10/2011SLR29212072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP011/19/2010SLR27229073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020685s073lbl.pdf 11/19/2010
AP02/17/2012SLR31853075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020685s075lbl.pdf 2/22/2012
AP02/17/2012SLR31899075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020685s075ltr.pdf 2/27/2012
AP07/24/2014SLR40012076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020685s076lbl.pdf 7/28/2014
AP07/24/2014SLR40014076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020685Orig1s076ltr.pdf 7/28/2014
AP03/27/2015SLR42408077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020685Orig1s077ltr.pdf 4/3/2015
AP03/27/2015SLR42463077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf 4/7/2015
AP09/15/2016SLR47091078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020685Orig1s078ltr.pdf 9/20/2016
AP09/15/2016SLR47155078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020685s078lbl.pdf 9/23/2016




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