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FDA Drug Application 020726 by NOVARTIS PHARMS

Application Number	020726
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS PHARMS
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 URL	Document Date
AP	7/25/1997	N	6417	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020726_femara_toc.cfm	8/7/2003
AP	3/17/1999	SCM
AP	4/22/1999	SCP
AP	2/5/2001	SCS
AP	5/23/2000	SCM
AP	2/26/2003	SE8	4050	005	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s005lbl.pdf	3/4/2003
AP	2/26/2003	SE8	4254	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726se8-005ltr.pdf	3/10/2003
AP	1/10/2001	SE1	1581	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20726S006LTR.PDF	1/10/2001
AP	1/10/2001	SE1	1582	006	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20726S006LBL.PDF	1/10/2001
AP	1/10/2001	SE1	1844	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-726S006_Femara.cfm	1/10/2001
AP	1/10/2002	SCM
AP	1/17/2003	SE8	4207	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s008lbl.pdf	1/17/2003
AP	1/17/2003	SE8	9001	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726s8ltr.pdf	6/4/2004
AP	10/29/2004	SE1	10509	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020726s011lbl.pdf	10/29/2004
AP	10/29/2004	SE1	11028	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20726s011ltr.pdf	1/26/2005
AP	12/28/2005	SE1	13338	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020726s012lbl.pdf	1/5/2006
AP	12/28/2005	SE1	13356	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020726s012rev2.pdf	1/6/2006
AP	6/26/2006	SLR	14353	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020726s013LTR.pdf	6/27/2006
AP	4/11/2007	SLR	16249	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020726s014LTR.pdf	4/20/2007
AP	4/11/2007	SLR	16278	014	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020726s014lbl.pdf	4/20/2007
AP	3/2/2010	SE8	24919	015	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf	3/3/2010
AP	3/2/2010	SE8	24992	015	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf	3/8/2010
AP	3/2/2010	SE8	24920	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf	3/3/2010
AP	3/2/2010	SE8	24993	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf	3/8/2010
AP	8/7/2008	SLR	20602	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020726s017ltr.pdf	8/13/2008
AP	7/7/2009	SLR	22926	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020726s018lbl.pdf	7/9/2009
AP	7/7/2009	SLR	22984	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020726s018ltr.pdf	7/17/2009
AP	6/25/2010	SLR	25830	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s019ltr.pdf	6/29/2010
AP	6/25/2010	SLR	25892	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s019lbl.pdf	7/1/2010
AP	4/30/2010	SE7	25465	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s020ltr.pdf	5/6/2010
AP	4/30/2010	SE7	25470	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s020lbl.pdf	5/6/2010
AP	12/23/2011	N	31243	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020726s024lbl.pdf	12/23/2011
AP	12/23/2011	N	31312	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020726s024ltr.pdf	1/3/2012
AP	7/11/2013	SCM
AP	1/15/2014	SLR	38297	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf	1/16/2014
AP	1/15/2014	SLR	38311	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020726Orig1s027ltr.pdf	1/17/2014
AP	12/23/2015	SCM

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