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FDA Drug Application 018029 by NOVARTIS

Application Number	018029
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/30/1982	N	16557	000	http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm	5/10/2007
AP	3/30/1982	N	24072	000	http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089095.pdf	11/20/2009
AP	10/31/1988	SCS
AP	9/14/1983	SCS
AP	3/13/1985	SCE
AP	1/21/1986	SLR
AP	10/7/1986	SCS
AP	4/20/1987	SCS
AP	7/21/1988	SCS
AP	7/9/1997	SLR
AP	3/9/1990	SCM
AP	3/9/1994	SCS
AP	7/9/1997	SLR
AP	4/15/1994	SCS
AP	6/18/1993	SCS
AP	5/31/1994	SCS
AP	8/19/1994	SCM
AP	7/9/1997	SLR
AP	12/15/1995	SLR
AP	7/9/1997	SLR
AP	2/20/1998	SLR
AP	4/24/1998	SCS
AP	8/12/1998	SCS
AP	9/17/1998	SCM
AP	11/24/1998	SCM
AP	4/15/1999	SCP
AP	5/21/2004	SLR	8681	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf	5/27/2004
AP	5/21/2004	N	8682	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf	5/27/2004
AP	3/13/2001	SCS
AP	8/15/2001	SCS
AP	1/11/2002	SLR	3219	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf	1/11/2002
AP	5/29/2002	SCM
AP	6/12/2002	SCS
AP	8/8/2006	SLR	14646	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf	8/9/2006
AP	8/8/2006	SLR	14677	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf	8/11/2006
AP	8/8/2006	SLR	14647	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf	8/9/2006
AP	8/8/2006	SLR	14678	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf	8/11/2006
AP	4/25/2007	SLR	16353	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf	5/1/2007
AP	4/25/2007	SLR	16395	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf	5/1/2007
AP	11/15/2010	SLR	26973	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf	11/17/2010
AP	11/15/2010	SLR	26983	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf	11/18/2010
AP	12/9/2010	SLR	27272	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf	12/10/2010
AP	12/9/2010	SLR	27290	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf	12/15/2010
AP	6/7/2013	SLR	36254	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf	6/11/2013
AP	6/7/2013	SLR	36260	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf	6/11/2013
AP	10/25/2013	SCM
AP	12/13/2013	SLR	38049	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf	12/16/2013
AP	12/13/2013	SLR	38059	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf	12/17/2013
AP	4/17/2015	SLR	42589	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf	4/21/2015
AP	4/17/2015	SLR	42604	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf	4/21/2015
AP	12/1/2015	SCM

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