Back to FDA Applications sponsored by MERCK

FDA Drug Application 019643 by MERCK

Application Number	019643
Application Type	New Drug Application
Sponsor Applicant	MERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	8/31/1987	N
AP	3/1/1988	SLR
AP	7/6/1988	SCM
AP	3/3/1988	SLR
AP	11/22/1988	SCP
AP	3/21/1989	SLR
AP	12/20/1988	SLR
AP	12/14/1988	SLR
AP	2/21/1991	SLR
AP	10/20/1989	SLR
AP	8/28/1991	SLR
AP	3/12/1991	SCS
AP	4/10/1991	SLR
AP	12/19/1991	SLR	16997	017		http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019643_S017_MEVACOR_TABLETS_AP.pdf	7/6/2007
AP	3/28/1991	SE2
AP	10/24/1991	SLR
AP	11/22/1993	SLR
AP	11/27/1991	SCF
AP	4/15/1992	SCS
AP	12/17/1992	SCP
AP	11/24/1993	SLR
AP	11/23/1993	SLR
AP	11/27/1992	SLR
AP	8/9/1993	SCP
AP	5/17/1994	SLR
AP	5/17/1994	SLR
AP	2/8/1995	SE1
AP	12/20/1994	SCS
AP	7/5/1994	SLR
AP	12/21/1994	SLR
AP	8/1/1995	SCM
AP	2/9/1996	SLR
AP	1/23/1995	SLR
AP	5/3/1995	SE2
AP	8/8/1995	SCS
AP	8/8/1995	SLR
AP	4/30/1996	SCS
AP	12/26/1996	SCS
AP	2/6/1997	SLR
AP	3/27/1997	SCM
AP	8/12/1997	SLR	4301	050		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s050.pdf	8/12/1997
AP	6/25/1997	SCS	4302	051		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf	6/25/1997
AP	11/20/1997	SCP
AP	4/22/1998	SLR	4303	053		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019643a_s051_s053.pdf	6/25/1997
AP	6/29/1998	SLR
AP	3/11/1999	SE1	899	055		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor.cfm	5/17/2000
AP	3/11/1999	SE1	4813	055		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19643S55_Mevacor_appltr.pdf	3/11/1999
AP	8/28/1998	SLR
AP	3/1/1999	SLR
AP	8/22/2000	SLR
AP	9/14/2000	SCM
AP	4/17/2007	SLR	16265	061		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s061lbl.pdf	4/20/2007
AP	4/17/2007	SLR	16316	061		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s061_LTR.pdf	4/25/2007
AP	4/26/2001	SLR	3587	062		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf	8/17/2001
AP	4/26/2001	SLR	3588	064		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19643S062_Mevacor.pdf	8/17/2001
AP	4/26/2001	SLR	5325	064		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s64lbl.pdf	4/16/2003
AP	8/1/2001	SCS
AP	6/26/2001	SCM
AP	2/14/2002	SE5	3585	067		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643s067ltr.pdf	2/14/2002
AP	2/14/2002	SE5	3586	067		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s067lbl.pdf	2/14/2002
AP	1/30/2002	SCS
AP	10/22/2001	SLR	5331	069		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19643s69lbl.pdf	4/17/2003
AP	9/23/2002	SCM
AP	9/20/2002	SLR	3576	071		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643slr071ltr.pdf	9/20/2002
AP	9/20/2002	SLR	3577	071		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19643s71lbl.pdf	9/20/2002
AP	10/17/2003	S	17004	073		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019643_S073_MEVACOR_TABLETS_AP.pdf	7/6/2007
AP	4/7/2005	SE8	11372	075		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19643s075ltr.pdf	4/12/2005
AP	4/7/2005	SE8	11380	075		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19643s075lbl.pdf	4/12/2005
AP	11/4/2005	SLR	13031	076		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s076lbl.pdf	11/8/2005
AP	11/4/2005	SLR	13098	076		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s076ltr.pdf	11/18/2005
AP	6/13/2005	SLR	11800	077		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s077ltr.pdf	6/14/2005
AP	6/13/2005	SLR	11812	077		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019643s077lbl.pdf	6/14/2005
AP	5/29/2007	SLR	16679	078		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s078ltr.pdf	6/4/2007
AP	5/29/2007	SLR	16698	078		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019643s078lbl.pdf	6/4/2007
AP	12/7/2007	SCM	18859	079		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s079ltr.pdf	1/9/2008
AP	3/9/2009	SCS	21984	080		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019643s080ltr.pdf	3/11/2009
AP	3/9/2009	SCS	22031	080		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019643s080lbl.pdf	3/17/2009
AP	6/30/2010	SLR	25910	081		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019643s081ltr.pdf	7/2/2010
AP	6/30/2010	SLR	25926	081		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019643s081lbl.pdf	7/6/2010
AP	6/10/2011	SLR	29217	082		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf	6/17/2011
AP	2/2/2011	SLR	27716	084		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019643s084lbl.pdf	2/4/2011
AP	2/2/2011	SLR	27752	084		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019643s084ltr.pdf	2/7/2011
AP	2/28/2012	SLR	31930	085		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf	2/28/2012
AP	2/28/2012	SLR	31931	085	Tracked Changes Label	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085-trackedchangeslbl.pdf	2/28/2012
AP	2/28/2012	SLR	31939	085		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643s085ltr.pdf	2/28/2012
AP	2/28/2012	SLR	32305	085		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019643s085.pdf	3/30/2012
AP	10/31/2012	SLR	34239	086		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf	11/5/2012
AP	10/31/2012	SLR	34280	086		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf	11/6/2012
AP	10/31/2012	SLR	34240	087		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf	11/5/2012
AP	10/31/2012	SLR	34279	087		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s086087lbl.pdf	11/6/2012
AP	2/27/2014	SLR	38631	088		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019643Orig1s088ltr.pdf	2/28/2014
AP	2/27/2014	SLR	38651	088		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019643s088lbl.pdf	3/4/2014

Back to FDA Applications sponsored by MERCK