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FDA Drug Application 019898 by BRISTOL MYERS SQUIBB

Application Number	019898
Application Type	New Drug Application
Sponsor Applicant	BRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	10/31/1991	N
AP	3/18/1992	SCM
AP	3/22/1993	SLR
AP	3/22/1993	SCS
AP	7/7/1992	SCP
AP	7/23/1993	SCS
AP	2/8/1994	SLR
AP	2/9/1994	SCF
AP	3/2/1994	SLR
AP	3/30/1995	SLR
AP	9/28/1994	SLR
AP	4/30/1996	SCS
AP	3/22/1996	SE1
AP	2/28/1996	SCS
AP	7/2/1996	SE1
AP	4/4/1996	SCS	18563	016		http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019898_S016_PRAVACOL_TABLETS.pdf	11/19/2007
AP	4/15/1997	SLR	4321	017		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019898a_s017_041597.pdf	4/15/1997
AP	3/27/1998	SE1	398	018		http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S018_Pravachol.pdf	3/27/1998
AP	5/20/1998	SLR
AP	3/11/1998	SE1	587	020		http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S020_Pravachol.pdf	3/11/1998
AP	8/17/1998	SLR
AP	10/26/1998	SCP
AP	2/11/1999	SCM	19171	023		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S023_PRAVACHOL_TABLETS.pdf	2/19/2008
AP	1/28/1999	SCM	19172	024		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S024_PRAVACHOL_TABLETS.pdf	2/19/2008
AP	4/9/1999	SCS	19173	025		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S025_PRAVACHOL_TABLETS.pdf	2/19/2008
AP	1/18/2000	SE1	1255	026		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF	1/18/2000
AP	1/18/2000	SE1	1261	027		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF	1/18/2000
AP	1/18/2000	SE2	1262	029		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF	1/18/2000
AP	1/18/2000	SE2	1263	030		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF	1/18/2000
AP	6/9/2000	SE1	1264	031		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S31LTR.PDF	6/9/2000
AP	6/9/2000	SE1	16212	031		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_S031_PRAVACHOL_TABLETS_AP.pdf	4/11/2007
AP	2/10/2000	SE1	1277	032		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/19898S32LTR.PDF	2/10/2000
AP	2/10/2000	SE1	3584	032		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898s032_Pravastatin.cfm	2/10/2000
AP	10/14/1999	SE1	1323	034		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF	10/14/1999
AP	10/14/1999	SE1	1324	034		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf	10/14/1999
AP	10/14/1999	SCM	1336	035		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF	10/14/1999
AP	10/14/1999	SCM	1337	035		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898S34.PDF	10/14/1999
AP	10/14/1999	SCM	1338	035		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf	10/14/1999
AP	9/13/1999	SLR	20532	036		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_s036_PRAVACHOL_TABLETS.pdf	8/8/2008
AP	6/23/2000	SE8	20491	037		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s037_PRAVACHOL_TABLETS.pdf	8/4/2008
AP	8/24/2000	SCF	20490	041		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s041_PRAVACHOL_TABLETS.pdf	8/4/2008
AP	6/15/2001	SE8	3582	042		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19898S42ltr.pdf	6/15/2001
AP	6/15/2001	SE8	3583	042		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf	6/15/2001
AP	3/12/2001	SCM	20471	043		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s043_PRAVACHOL TABS.pdf	8/4/2008
AP	3/14/2001	SCS	20470	044		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s044_PRAVACHOL TABS.pdf	8/4/2008
AP	8/13/2001	SCM
AP	12/18/2001	SE2	3677	046		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898s46ltr.pdf	12/18/2001
AP	12/18/2001	SE2	3678	046		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf	12/18/2001
AP	1/14/2002	SCM	18562	049		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S049_PRAVACOL_TABLETS.pdf	11/19/2007
AP	7/12/2002	SLR	3580	050		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898slr050ltr.pdf	7/12/2002
AP	7/12/2002	SLR	3581	050		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf	7/12/2002
AP	7/12/2002	SLR	20445	050		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_s050_PRAVACHOL TABS.pdf	8/4/2008
AP	6/14/2002	SCS	18561	051		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S051_PRAVACOL_TABLETS.pdf	11/19/2007
AP	10/29/2002	SE5	3578	052		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898se5-052ltr.pdf	10/29/2002
AP	10/29/2002	SE5	3579	052		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf	10/29/2002
AP	9/5/2003	SLR	6648	054		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19898slr054ltr.pdf	9/25/2003
AP	9/5/2003	SLR	6683	054		http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf	9/25/2003
AP	9/5/2003	SLR	20398	054		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019898_s054_PRAVACHOL TABS.pdf	8/1/2008
AP	7/6/2005	SLR	11987	058		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf	7/15/2005
AP	7/6/2005	SLR	11993	058		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019898s058ltr.pdf	7/15/2005
AP	2/28/2007	SE8	15981	060		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019898s060ltr.pdf	3/7/2007
AP	2/28/2007	SE8	15995	060		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf	3/7/2007
AP	5/18/2011	SLR	28873	061		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019898s061ltr.pdf	5/20/2011
AP	5/18/2011	SLR	28898	061		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf	5/23/2011
AP	5/18/2011	SLR	36720	061		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019898Orig1s061.pdf	8/7/2013
AP	2/28/2012	SLR	31941	062		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898s062ltr.pdf	2/28/2012
AP	2/28/2012	SLR	31947	062		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf	2/28/2012
AP	2/28/2012	SLR	31948	062	Tracked Changes Label	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062-trackedchangeslbl.pdf	2/28/2012
AP	2/28/2012	SLR	32304	062		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019898s062.pdf	3/30/2012
AP	10/31/2012	SLR	34246	063		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf	11/5/2012
AP	10/31/2012	SLR	34312	063		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf	11/6/2012
AP	10/31/2012	SLR	34247	064		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf	11/5/2012
AP	10/31/2012	SLR	34313	064		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf	11/6/2012
AP	5/29/2013	SCM
AP	7/5/2016	SLR	46470	066		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019898Orig1s066ltr.pdf	7/7/2016
AP	7/5/2016	SLR	46477	066		http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf	7/8/2016

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