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FDA Drug Application 020387 by MERCK SHARP DOHME

Application Number020387
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/28/1995N       
AP011/6/1995SCE       
AP011/22/1995SLR       
AP012/1/1995SCM3738003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-387S003_Hyzaar.pdf 4/30/2002
AP07/18/1996SLR       
AP011/7/1997SLR3674005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf 11/7/1997
AP08/24/1998SLR2284006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S006_Hyzaar.pdf 8/24/1998
AP03/27/1998SCP       
AP011/10/1998SCF2285008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S008_Hyzaar.pdf 11/10/1998
AP04/3/1998SLR       
AP08/25/1998SLR2286010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S010_Hyzaar.pdf 8/25/1998
AP011/24/1998SLR1083011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20387s011_Hyzaar.pdf 11/24/1998
AP06/9/1999SLR1204012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20387S012_Hyzaar.pdf 6/9/1999
AP09/30/2003SLR6922013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm 11/25/2003
AP09/30/2003SLR6759013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf 9/30/2003
AP09/30/2003SLR6775013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf 10/10/2003
AP01/28/2000SLR2612014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf 1/28/2001
AP09/30/2003SLR6923015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm 11/25/2003
AP09/30/2003SLR6760015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf 9/30/2003
AP09/30/2003SLR6776015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf 10/10/2003
AP02/23/2000SCS       
AP01/19/2000SLR2611017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf 1/19/2000
AP010/3/2001SLR       
AP07/3/2001SCS       
AP05/16/2001SCS       
AP06/22/2001SCM       
AP08/24/2001SLR       
AP01/10/2002SCM       
AP011/7/2002SLR2283024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20387slr024ltr.pdf 11/7/2002
AP010/23/2002SCS       
AP01/8/2003SCM       
AP09/30/2003SE16924027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm 11/25/2003
AP09/30/2003SE16761027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf 9/30/2003
AP09/30/2003SE16747027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf 10/9/2003
AP04/5/2005SE811376033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s033ltr.pdf 4/12/2005
AP04/5/2005SE811384033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s033lbl.pdf 4/12/2005
AP04/12/2005SLR11399034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf 4/13/2005
AP04/12/2005SLR11402034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf 4/13/2005
AP04/12/2005SLR11400035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf 4/13/2005
AP04/12/2005SLR11401035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf 4/13/2005
AP010/20/2005SE212952037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s037lbl.pdf 10/24/2005
AP010/20/2005SE212970037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s037ltr.pdf 10/25/2005
AP010/20/2005SE227869037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020387_s037_hyzaar.pdf 2/15/2011
AP04/20/2006SLR13974038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s038lbl.pdf 4/21/2006
AP04/20/2006SLR13983038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s038LTR.pdf 4/25/2006
AP012/21/2006SLR15604040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s040ltr.pdf 1/8/2007
AP08/29/2006SLR14773041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s041lbl.pdf 8/30/2006
AP08/29/2006SLR14869041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s041ltr.pdf 9/18/2006
AP06/12/2009SLR22770045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020387s045ltr.pdf 6/17/2009
AP06/12/2009SLR22787045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020387s045lbl.pdf 6/22/2009
AP012/11/2015SLR44765047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020387Orig1s047ltr.pdf 12/15/2015
AP012/11/2015SLR44775047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020387s047lbl.pdf 12/15/2015
AP09/21/2010SLR26533048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020387s048lbl.pdf 9/23/2010
AP09/21/2010SLR26541048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020387s048ltr.pdf 9/27/2010
AP06/10/2011SLR29213050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP08/17/2011SLR29825052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s052ltr.pdf 8/18/2011
AP08/17/2011SLR29849052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s052lbl.pdf 8/24/2011
AP011/17/2011SLR30697054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf 11/21/2011
AP011/17/2011SLR30718054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387Orig1s054Lbl_REPLACEMENT.pdf 11/21/2011
AP08/26/2011SLR29920055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s055lbl.pdf 8/30/2011
AP08/26/2011SLR29927055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s055ltr.pdf 8/31/2011
AP09/28/2012SLR33921056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf 10/2/2012
AP09/28/2012SLR33945056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020387Orig1s056ltr.pdf 10/3/2012
AP03/27/2013SLR35572057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020387Orig1s057ltr.pdf 3/29/2013
AP03/27/2013SLR35610057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020387s057lbl.pdf 4/1/2013
AP01/17/2014SLR38336059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s059_replace_ltr.pdf 1/21/2014
AP01/17/2014SLR38344059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf 1/22/2014
AP09/30/2014SLR40673060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s060lbl.pdf 9/30/2014
AP09/30/2014SLR40683060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s060ltr.pdf 10/1/2014




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