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FDA Drug Application 020386 by MERCK SHARP DOHME

Application Number020386
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/14/1995N31205000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP012/29/1995SE4       
AP011/22/1995SLR       
AP012/1/1995SCM       
AP07/18/1996SLR       
AP08/7/1996SCS       
AP02/25/1998SLR       
AP011/7/1997SLR3673007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf 11/7/1997
AP010/13/1998SCS2613008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386-s008_cozaar.pdf 10/13/1998
AP03/9/1998SCM       
AP03/27/1998SCM       
AP08/31/1998SLR       
AP04/3/1998SLR       
AP08/31/1998SLR       
AP08/31/1998SLR       
AP011/24/1998SLR1081015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386s015_Cozaar.pdf 11/24/1998
AP05/13/1999SCS       
AP06/9/1999SLR1202017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20386S017_Cozaar.pdf 6/9/1999
AP01/28/2000SLR2610018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf 1/28/2000
AP03/11/2004SLR7945019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf 3/16/2004
AP03/11/2004SLR8518019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf 5/6/2004
AP03/11/2004SLR9039019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm 6/4/2004
AP01/19/2000SLR2609020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf 6/6/2001
AP02/23/2000SCS       
AP010/3/2001SLR       
AP07/3/2001SCS       
AP05/16/2001SCS       
AP06/22/2001SCM       
AP08/24/2001SLR       
AP01/10/2002SCM       
AP09/17/2002SE18879028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-386s028_Cozaar.cfm 6/2/2004
AP09/17/2002SE12607028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20386se1-028ltr.pdf 9/17/2002
AP09/17/2002SE12608028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf 9/17/2002
AP03/11/2004SLR11062029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm 2/2/2005
AP03/11/2004SLR7946029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf 3/16/2004
AP03/11/2004SLR8517029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf 5/6/2004
AP010/23/2002SCS       
AP03/25/2003SE14474032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf 3/25/2003
AP03/25/2003SE14655032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20386se1-032ltr.pdf 3/28/2003
AP03/25/2003SE16113032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-386s032_Cozaar.cfm 7/8/2003
AP04/12/2005SLR11396039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf 4/13/2005
AP04/12/2005SLR11397039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf 4/13/2005
AP04/12/2005SLR11398040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf 4/13/2005
AP04/12/2005SLR11395040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf 4/13/2005
AP03/31/2006SLR13889042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s042ltr.pdf 4/7/2006
AP04/13/2006SLR13941043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf 4/14/2006
AP19/21/2006SLR13941043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf 4/14/2006
AP04/13/2006SLR14967043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf 9/25/2006
AP19/21/2006SLR14967043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf 9/25/2006
AP04/13/2006SLR14949043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf 9/25/2006
AP19/21/2006SLR14949043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf 9/25/2006
AP08/29/2006SLR14774045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf 8/30/2006
AP08/29/2006SLR14870045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s045ltr.pdf 9/18/2006
AP09/21/2006SLR14968046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043s046pi.pdf 9/25/2006
AP09/21/2006SLR14950046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf 9/25/2006
AP06/4/2009SLR22697049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf 6/4/2009
AP06/4/2009SLR22748049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020386s049ltr.pdf 6/16/2009
AP09/21/2010SLR26532052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf 9/23/2010
AP09/21/2010SLR26540052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020386s052ltr.pdf 9/27/2010
AP06/10/2011SLR29211053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP012/11/2015SLR44764054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020386Orig1s054ltr.pdf 12/15/2015
AP012/11/2015SLR44774054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf 12/15/2015
AP011/17/2011SLR30696056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf 11/21/2011
AP011/17/2011SLR30719056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf 11/21/2011
AP09/28/2012SLR33924057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf 10/2/2012
AP09/28/2012SLR33944057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020386Orig1s057ltr.pdf 10/3/2012
AP03/27/2013SLR35573058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020386Orig1s058ltr.pdf 3/29/2013
AP03/27/2013SLR35606058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf 4/1/2013
AP02/20/2014SCM       
AP01/17/2014SLR38337060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s060ltr_replace.pdf 1/21/2014
AP01/17/2014SLR38343060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf 1/22/2014
AP09/29/2014SLR40671061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf 9/30/2014
AP09/29/2014SLR40682061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s061ltr.pdf 10/1/2014




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