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FDA Drug Application 020261 by NOVARTIS

Application Number	020261
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
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	12/31/1993	N
AP	3/13/1995	SCS
AP	3/21/1994	SLR	23335	002		http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_s002_Lescol Capsules.pdf	9/16/2009
AP	11/28/1994	SCP	16994	003		http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S003_LESCOL_AP.pdf	7/6/2007
AP	11/10/1994	SCS	16993	004		http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S004_LESCOL_AP.pdf	7/6/2007
AP	5/3/1995	SLR
AP	3/20/1996	SE2
AP	10/17/1995	SCS	19192	007		http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S007_LESCOL_CAPSULES.pdf	2/19/2008
AP	12/22/1995	SCM
AP	2/8/1996	SCS	19191	009		http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S009_LESCOL_CAPSULES.pdf	2/19/2008
AP	4/30/1996	SCM	17888	010		http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020261_S010_LESCOL.pdf	9/14/2007
AP	10/8/1998	SCS	19587	011		http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S011_LESCOL_CAPSULES.pdf	4/2/2008
AP	10/1/1997	SE1
AP	6/16/1997	SCS	18113	013		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S013_LESCOL.pdf	9/26/2007
AP	4/21/1997	SCP	18112	014		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S014_LESCOL.pdf	9/26/2007
AP	11/20/1997	SCP	19214	015		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S016_LESCOL_TABLETS.pdf	2/19/2008
AP	4/23/1998	SCS	19213	016		http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S016_LESCOL_TABLETS.pdf	2/19/2008
AP	8/5/1998	SCM	19212	017		http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S017_LESCOL_TABLETS.pdf	2/19/2008
AP	3/8/1999	SE1	977	018		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm	5/8/1999
AP	3/8/1999	SE1	4785	018		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf	3/8/1999
AP	1/4/1999	SLR	19586	019		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S019_LESCOL_CAPSULES.pdf	4/2/2008
AP	4/21/1999	SCP	19196	020		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S020_LESCOL_CAPSULES.pdf	2/19/2008
AP	5/14/1999	SCS	19195	021		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S021_LESCOL_CAPSULES.pdf	2/19/2008
AP	3/8/1999	SE8	1240	022		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm	3/8/1999
AP	3/8/1999	SE8	4786	022		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf	3/8/1999
AP	10/14/1999	SCM
AP	10/23/2000	SE8	1503	024		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S24ltr.pdf	10/23/2000
AP	10/23/2000	SE8	1504	024		http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20261S24lbl.pdf	10/23/2000
AP	12/18/2000	SE1	1518	025		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S25ltr.pdf	12/18/2000
AP	7/26/2000	SCM
AP	10/6/2000	SLR	9159	028		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.cfm	6/8/2004
AP	10/6/2000	SLR	9160	028		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Approv.pdf	6/8/2004
AP	10/6/2000	SLR	9161	028		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf	6/8/2004
AP	5/23/2001	SCM	20469	029		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020261_s029_LESCOL_CAPSULES.pdf	8/4/2008
AP	9/25/2001	SLR	5405	030		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20261s30lbl.pdf	4/22/2003
AP	2/11/2002	SCM	20444	031		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s031_LESCOL_CAPSULES.pdf	8/4/2008
AP	9/6/2002	SLR	2776	032		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf	9/6/2002
AP	9/6/2002	SLR	2777	032		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf	9/6/2002
AP	9/6/2002	SLR	20443	032		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s032_LESCOL_CAPSULES.pdf	8/4/2008
AP	5/27/2003	SE1	5809	033		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf	6/8/2003
AP	5/27/2003	SE1	5880	033		http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf	6/8/2003
AP	5/27/2003	SE1	16195	033		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020261_S033_LESCOL_CAPS_AP.pdf	4/9/2007
AP	1/5/2005	SLR	10929	034		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf	1/11/2005
AP	1/5/2005	SLR	10940	034		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf	1/11/2005
AP	1/5/2005	SLR	23336	034		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020261_s034_Lescol Capsules.pdf	9/16/2009
AP	4/10/2006	SE2	13895	035		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf	4/12/2006
AP	4/10/2006	SE2	13906	035		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf	4/13/2006
AP	4/10/2006	SE5	13896	036		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf	4/12/2006
AP	4/10/2006	SE5	13907	036		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf	4/13/2006
AP	3/22/2006	SLR	13861	037		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf	4/5/2006
AP	3/22/2006	SLR	13864	037		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf	4/5/2006
AP	6/12/2007	SLR	16771	039		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf	6/14/2007
AP	6/12/2007	SLR	16776	039		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf	6/14/2007
AP	6/17/2011	SLR	29293	042		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf	6/28/2011
AP	6/17/2011	SLR	29310	042		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf	6/28/2011
AP	2/28/2012	SLR	31935	046		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf	2/28/2012
AP	2/28/2012	SLR	31938	046	Tracked Changes Label	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261S046-trackedchangeslbl.pdf	2/28/2012
AP	2/28/2012	SLR	31945	046		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf	2/28/2012
AP	2/28/2012	SLR	32303	046		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020261s046.pdf	3/30/2012
AP	6/25/2013	SCM
AP	10/31/2012	SLR	34251	048		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf	11/5/2012
AP	10/31/2012	SLR	34318	048		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf	11/6/2012
AP	6/17/2015	SCM
AP	11/5/2015	SCM
AP	9/19/2016	SCM

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