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FDA Drug Application 017911 by MERCK

Application Number017911
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/27/1978N23915000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf 11/16/2009
AP08/14/1979SCE       
AP07/23/1979SCM       
AP08/8/1979SLR       
AP08/6/1979SLR       
AP05/12/1981SLR       
AP010/1/1979SCS       
AP08/8/1979SCS       
AP012/14/1981SCP       
AP012/14/1981SLR       
AP012/21/1981SCP       
AP06/5/1981SCM       
AP04/27/1981SCP       
AP05/12/1993SCF       
AP011/20/1984SCM       
AP06/29/1982SLR       
AP06/22/1982SLR       
AP06/22/1982SLR       
AP06/29/1983SCS       
AP05/29/1984SCS       
AP08/13/1984SCS       
AP05/31/1989SLR       
AP01/26/1984SLR       
AP07/26/1984SCM       
AP011/26/1984SLR       
AP02/5/1986SLR       
AP02/5/1986SLR       
AP02/5/1986SLR       
AP01/9/1989SLR       
AP01/9/1989SLR       
AP01/9/1989SLR       
AP05/3/1988SCM       
AP01/9/1989SLR       
AP01/9/1989SLR       
AP02/6/1989SCS       
AP01/9/1989SLR       
AP05/31/1989SLR       
AP05/31/1989SLR       
AP07/27/1992SCS       
AP06/1/1995SLR       
AP07/10/1995SLR       
AP08/18/1994SCS       
AP010/24/1994SCS       
AP03/1/1996SCM       
AP05/2/1997SCS       
AP04/14/1997SCS       
AP010/5/2006SLR15068065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s065_lbl.pdf 10/11/2006
AP010/5/2006SLR15093065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s065ltr.pdf 10/13/2006
AP010/30/2001SLR       
AP02/7/2001SCS       
AP01/24/2006SLR13491068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf 1/25/2006
AP01/24/2006SLR13527068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s068ltr.pdf 1/30/2006
AP08/23/2007SLR17710070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf 8/27/2007
AP08/23/2007SLR17722070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017911s070ltr.pdf 8/27/2007
AP03/30/2009SLR22157072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017911s072ltr.pdf 4/3/2009
AP03/30/2009SLR22181072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017911s072lbl.pdf 4/3/2009
AP06/4/2010SLR25711073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf 6/7/2010
AP06/4/2010SLR25724073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s073ltr.pdf 6/10/2010
AP012/23/2010SLR27369074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf 12/26/2010
AP012/23/2010SLR27411074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s074ltr.pdf 12/28/2010




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