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FDA Drug Application 050625 by NOVARTIS

Application Number	050625
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/2/1990	N
AP	11/21/1991	SCP
AP	8/24/1990	SLR
AP	12/30/1992	SCS
AP	12/30/1992	SCE
AP	6/10/1991	SLR
AP	2/21/1992	SCS
AP	11/23/1992	SCS
AP	3/19/1993	SCS
AP	11/2/1992	SCP
AP	5/17/1993	SCP
AP	5/9/1994	SCS
AP	5/9/1994	SCS
AP	3/7/1995	SCM
AP	11/10/1994	SLR
AP	1/13/1995	SCS
AP	11/21/1995	SCE
AP	11/21/1995	SLR
AP	8/9/1996	SLR
AP	4/15/1996	SCS
AP	3/30/1998	SCM
AP	10/4/2000	SLR
AP	12/21/1999	SLR
AP	6/30/2000	SCM
AP	2/14/2003	SLR	4099	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf	3/5/2003
AP	2/14/2003	SLR	9415	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf	6/17/2004
AP	2/14/2003	SLR	4100	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf	3/5/2003
AP	2/14/2003	SLR	9416	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf	6/17/2004
AP	1/16/2002	SCM
AP	4/12/2002	SCM
AP	2/6/2004	SLR	7737	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf	2/27/2004
AP	2/6/2004	SLR	7819	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf	3/3/2004
AP	2/6/2004	SLR	7820	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf	3/3/2004
AP	2/6/2004	SLR	9414	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf	6/17/2004
AP	7/19/2005	SLR	12275	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf	7/26/2005
AP	7/19/2005	SLR	12287	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf	7/26/2005
AP	3/6/2006	SLR	13745	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf	3/10/2006
AP	3/6/2006	SLR	13820	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf	3/23/2006
AP	10/8/2009	SLR	23583	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf	10/14/2009
AP	10/8/2009	SLR	23773	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf	11/10/2009
AP	4/30/2010	SLR	25467	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf	5/6/2010
AP	4/30/2010	SLR	25488	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf	5/7/2010
AP	8/30/2012	SLR	33622	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf	8/31/2012
AP	8/30/2012	SLR	33635	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf	9/5/2012
AP	5/3/2013	SLR	35974	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf	5/7/2013
AP	5/3/2013	SLR	35989	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf	5/9/2013
AP	3/31/2015	SLR	42357	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf	4/1/2015
AP	3/31/2015	SLR	42377	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf	4/2/2015
AP	1/6/2016	SCM

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