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FDA Drug Application 019643 by MERCK

Application Number019643
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/31/1987N       
AP03/1/1988SLR       
AP07/6/1988SCM       
AP03/3/1988SLR       
AP011/22/1988SCP       
AP03/21/1989SLR       
AP012/20/1988SLR       
AP012/14/1988SLR       
AP02/21/1991SLR       
AP010/20/1989SLR       
AP08/28/1991SLR       
AP03/12/1991SCS       
AP04/10/1991SLR       
AP012/19/1991SLR16997017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019643_S017_MEVACOR_TABLETS_AP.pdf 7/6/2007
AP03/28/1991SE2       
AP010/24/1991SLR       
AP011/22/1993SLR       
AP011/27/1991SCF       
AP04/15/1992SCS       
AP012/17/1992SCP       
AP011/24/1993SLR       
AP011/23/1993SLR       
AP011/27/1992SLR       
AP08/9/1993SCP       
AP05/17/1994SLR       
AP05/17/1994SLR       
AP02/8/1995SE1       
AP012/20/1994SCS       
AP07/5/1994SLR       
AP012/21/1994SLR       
AP08/1/1995SCM       
AP02/9/1996SLR       
AP01/23/1995SLR       
AP05/3/1995SE2       
AP08/8/1995SCS       
AP08/8/1995SLR       
AP04/30/1996SCS       
AP012/26/1996SCS       
AP02/6/1997SLR       
AP03/27/1997SCM       
AP08/12/1997SLR4301050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s050.pdf 8/12/1997
AP06/25/1997SCS4302051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf 6/25/1997
AP011/20/1997SCP       
AP04/22/1998SLR4303053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf 6/25/1997
AP06/29/1998SLR       
AP03/11/1999SE14813055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor_appltr.pdf 3/11/1999
AP03/11/1999SE1899055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor.cfm 5/17/2000
AP08/28/1998SLR       
AP03/1/1999SLR       
AP08/22/2000SLR       
AP09/14/2000SCM       
AP04/17/2007SLR16265061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf 4/20/2007
AP04/17/2007SLR16316061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s061_LTR.pdf 4/25/2007
AP04/26/2001SLR3587062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf 8/17/2001
AP04/26/2001SLR3588064   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf 8/17/2001
AP04/26/2001SLR5325064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf 4/16/2003
AP08/1/2001SCS       
AP06/26/2001SCM       
AP02/14/2002SE53585067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643s067ltr.pdf 2/14/2002
AP02/14/2002SE53586067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf 2/14/2002
AP01/30/2002SCS       
AP010/22/2001SLR5331069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf 4/17/2003
AP09/23/2002SCM       
AP09/20/2002SLR3576071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643slr071ltr.pdf 9/20/2002
AP09/20/2002SLR3577071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf 9/20/2002
AP010/17/2003S17004073   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019643_S073_MEVACOR_TABLETS_AP.pdf 7/6/2007
AP04/7/2005SE811372075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19643s075ltr.pdf 4/12/2005
AP04/7/2005SE811380075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf 4/12/2005
AP011/4/2005SLR13031076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf 11/8/2005
AP011/4/2005SLR13098076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s076ltr.pdf 11/18/2005
AP06/13/2005SLR11800077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s077ltr.pdf 6/14/2005
AP06/13/2005SLR11812077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf 6/14/2005
AP05/29/2007SLR16679078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s078ltr.pdf 6/4/2007
AP05/29/2007SLR16698078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf 6/4/2007
AP012/7/2007SCM18859079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s079ltr.pdf 1/9/2008
AP03/9/2009SCS21984080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019643s080ltr.pdf 3/11/2009
AP03/9/2009SCS22031080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf 3/17/2009
AP06/30/2010SLR25910081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019643s081ltr.pdf 7/2/2010
AP06/30/2010SLR25926081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf 7/6/2010
AP06/10/2011SLR29217082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP02/2/2011SLR27716084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf 2/4/2011
AP02/2/2011SLR27752084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019643s084ltr.pdf 2/7/2011
AP02/28/2012SLR31930085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf 2/28/2012
AP02/28/2012SLR31931085Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR31939085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643s085ltr.pdf 2/28/2012
AP02/28/2012SLR32305085   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019643s085.pdf 3/30/2012
AP010/31/2012SLR34239086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf 11/5/2012
AP010/31/2012SLR34280086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf 11/6/2012
AP010/31/2012SLR34240087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf 11/5/2012
AP010/31/2012SLR34279087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf 11/6/2012
AP02/27/2014SLR38631088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019643Orig1s088ltr.pdf 2/28/2014
AP02/27/2014SLR38651088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf 3/4/2014




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