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FDA Drug Application 019201 by NOVARTIS

Application Number	019201
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 URL	Document Date
AP	7/28/1988	N	24202	000	http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089822.pdf	12/4/2009
AP	7/20/1989	SCS
AP	7/11/1989	SCS
AP	2/6/1989	SCM
AP	12/30/1988	SLR
AP	2/12/1991	SCS
AP	9/27/1989	SCP
AP	2/12/1990	SCS
AP	1/24/1990	SLR
AP	4/21/1992	SCS
AP	4/20/1993	SCM
AP	1/4/1993	SCS
AP	12/8/1994	SCS
AP	11/26/2002	SLR	2823	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19201slr018ltr.pdf	11/26/2002
AP	11/26/2002	SLR	11094	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-201s018_Voltaren.cfm	2/8/2005
AP	11/2/1995	SCM
AP	7/28/1995	SLR
AP	12/22/1995	SCM
AP	4/20/1998	SLR
AP	10/31/2001	SLR
AP	3/11/1997	SCS
AP	5/16/1997	SCM
AP	2/9/1999	SCM
AP	4/22/1999	SCP
AP	2/18/2000	SCM
AP	9/20/2000	SCS
AP	10/23/2000	SCM
AP	9/28/2001	SCS
AP	3/11/2002	SCM
AP	9/19/2002	SCS
AP	1/24/2006	SLR	13480	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf	1/25/2006
AP	1/24/2006	SLR	13537	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf	1/30/2006
AP	7/9/2007	SLR	17270	036	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf	7/10/2007
AP	7/9/2007	SLR	17283	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019201s036ltr.pdf	7/16/2007
AP	2/25/2009	SLR	21915	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019201s038ltr.pdf	2/27/2009
AP	2/25/2009	SLR	22015	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf	3/17/2009
AP	2/23/2011	SLR	27983	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28040	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf	3/4/2011
AP	2/23/2011	SLR	27984	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28041	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf	3/4/2011
AP	1/25/2013	SCM
AP	6/5/2014	SCM
AP	5/9/2016	SLR	45966	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf	5/11/2016
AP	5/9/2016	SLR	46003	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019201Orig1s046ltr.pdf	5/12/2016

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