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FDA Drug Application 020818 by NOVARTIS

Application Number	020818
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	3/6/1998	N	6453	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020818_diovan_toc.cfm	8/8/2003
AP	0	3/6/1998	N	8920	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_APPROV.PDF	6/2/2004
AP	0	3/6/1998	N	8921	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20818_DIOVAN_PRNTLBL.PDF	6/2/2004
AP	0	3/6/1998	N	31207	000	http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm	12/22/2011
AP	0	11/16/1998	SCS
AP	0	2/18/1999	SCM
AP	0	4/28/1999	SCP
AP	0	6/16/1999	SLR
AP	0	4/18/2000	SCS
AP	0	3/1/2000	SLR
AP	0	5/10/2000	SCM
AP	0	11/2/2000	SCM
AP	0	9/27/2001	SCM
AP	0	10/23/2001	SCM
AP	0	1/17/2002	SCS	1708	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20818s12ltr.pdf	1/17/2002
AP	0	4/29/2002	SCM
AP	0	11/6/2002	SCS
AP	0	8/1/2002	SCM
AP	0	1/15/2003	SE8	6115	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818s016_Diovan.cfm	7/8/2003
AP	0	1/15/2003	SE8	8922	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818S016_Diovan_Approv.pdf	6/2/2004
AP	1	7/7/2005	SLR	11976	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20818s024PiJul7.pdf	7/8/2005
AP	1	7/7/2005	SLR	11989	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020818s024lbl.pdf	7/15/2005
AP	1	7/7/2005	SLR	11999	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020818s024ltr.pdf	7/15/2005
AP	0	4/28/2006	SE2	14044	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s027LTR.pdf	5/2/2006
AP	0	4/28/2006	SE2	14046	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf	5/2/2006
AP	0	11/20/2006	SLR	15382	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf	11/22/2006
AP	0	11/20/2006	SLR	15438	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020818s032ltr.pdf	12/4/2006
AP	0	9/6/2007	SLR	17865	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020818s035_ltr.pdf	9/11/2007
AP	0	7/31/2008	SE1	20499	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020818s036ltr.pdf	8/5/2008
AP	0	4/21/2010	SLR	25342	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020818s043ltr.pdf	4/23/2010
AP	0	4/21/2010	SLR	25433	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf	5/3/2010
AP	0	12/12/2011	SLR	30926	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s046lbl.pdf	12/12/2011
AP	0	12/12/2011	SLR	30975	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf	12/14/2011
AP	0	6/3/2011	SLR	29076	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s047ltr.pdf	6/9/2011
AP	0	6/3/2011	SLR	29276	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s047lbl.pdf	6/27/2011
AP	0	12/12/2011	SLR	30927	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020818s049lbl.pdf	12/12/2011
AP	0	12/12/2011	SLR	30976	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020818s046,s049ltr.pdf	12/14/2011
AP	0	2/16/2012	SLR	31812	051	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818s051ltr.pdf	2/17/2012
AP	0	2/16/2012	SLR	31825	051	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf	2/17/2012
AP	0	1/18/2012	SLR	31435	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283s036,020818s053ltr.pdf	1/23/2012
AP	0	1/18/2012	SLR	31463	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf	1/23/2012
AP	0	7/26/2012	SLR	33289	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021283Orig1s037,020818Orig1s054ltr.pdf	7/30/2012
AP	0	7/26/2012	SLR	33311	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s054lbl.pdf	7/30/2012
AP	0	10/4/2012	SLR	33987	056	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s056lbl.pdf	10/5/2012
AP	0	10/4/2012	SLR	33993	056	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020818Orig1s056ltr.pdf	10/9/2012
AP	0	3/17/2014	SLR	38812	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf	3/19/2014
AP	0	3/17/2014	SLR	38835	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf	3/19/2014
AP	0	4/23/2014	SCM
AP	0	5/30/2014	SCM	39427	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s060ltr.pdf	6/3/2014
AP	0	5/30/2014	SCM	39437	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf	6/3/2014
AP	0	3/17/2014	SLR	38813	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818s058,s062ltr.pdf	3/19/2014
AP	0	3/17/2014	SLR	38836	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf	3/19/2014
AP	0	9/24/2014	SLR	40613	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020818Orig1s064ltr.pdf	9/26/2014
AP	0	9/24/2014	SLR	40632	064	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s064lbl.pdf	9/26/2014
AP	0	5/22/2015	SCM
AP	0	7/27/2015	SLR	43533	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020818s066lbl.pdf	7/30/2015
AP	0	11/13/2015	SCM
AP	0	8/1/2016	SCM

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