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FDA Drug Application 020083 by JANSSEN PHARMS

Application Number	020083
Application Type	New Drug Application
Sponsor Applicant	JANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority*
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	9/11/1992	N
AP	10/13/1992	SCM
AP	12/28/1992	SLR
AP	6/9/1993	SCM
AP	3/29/1994	SE1
AP	5/9/1994	SCM
AP	11/9/1993	SLR
AP	10/12/1994	SCM
AP	9/8/1995	SCM
AP	9/15/1995	SCM
AP	5/23/1996	SLR
AP	3/22/1996	SCM
AP	12/10/1996	SLR
AP	8/6/1997	SLR
AP	8/6/1997	SLR
AP	11/3/1997	SCS
AP	7/27/1998	SCS
AP	7/27/1998	SCP
AP	2/17/1999	SCS
AP	9/29/1999	SCP
AP	5/9/2001	SLR	5449	025	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20083s25lbl.pdf	4/24/2003
AP	3/21/2001	SCE
AP	2/27/2002	SCS
AP	7/17/2002	SLR	3289	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf	7/17/2002
AP	7/17/2002	SLR	3290	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf	7/17/2002
AP	4/11/2002	SLR	3293	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083s29ltr.pdf	4/11/2002
AP	4/11/2002	SLR	3294	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s29lbl.pdf	4/11/2002
AP	10/10/2002	SCS
AP	7/17/2002	SLR	3291	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20083s28s31lbl.pdf	7/17/2002
AP	7/17/2002	SLR	3292	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20083slr028,031ltr.pdf	7/17/2002
AP	11/10/2003	SLR	6934	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20083slr033ltr.pdf	11/25/2003
AP	11/10/2003	SLR	7018	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20083slr033_sporanox_lbl.pdf	12/2/2003
AP	7/14/2004	SLR	9782	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf	7/21/2004
AP	7/14/2004	SLR	9783	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf	7/21/2004
AP	7/14/2004	SLR	9811	034	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf	7/21/2004
AP	7/14/2004	SLR	9784	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20083s034,035ltr.pdf	7/21/2004
AP	7/14/2004	SLR	9812	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20083s034,035lbl.pdf	7/21/2004
AP	3/5/2009	SLR	21970	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf	3/10/2009
AP	3/5/2009	SLR	22035	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf	3/17/2009
AP	3/5/2009	SLR	21971	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf	3/10/2009
AP	3/5/2009	SLR	22036	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf	3/17/2009
AP	3/5/2009	SLR	21972	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020083s040,s041,s044ltr.pdf	3/10/2009
AP	3/5/2009	SLR	22037	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020083s040s041s044lbl.pdf	3/17/2009
AP	7/29/2010	SLR	26072	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020083s046lbl.pdf	7/31/2010
AP	7/29/2010	SLR	26092	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020083s046,020657s024ltr.pdf	8/3/2010
AP	4/18/2012	SLR	32490	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf	4/20/2012
AP	4/18/2012	SLR	32499	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf	4/23/2012
AP	4/18/2012	SLR	32491	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf	4/20/2012
AP	4/18/2012	SLR	32500	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf	4/23/2012
AP	4/18/2012	SLR	32492	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf	4/20/2012
AP	4/18/2012	SLR	32501	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020083s048,s049,s050ltr.pdf	4/23/2012
AP	3/1/2013	SCM
AP	6/5/2013	SCM
AP	6/9/2014	SLR	39465	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020083s053lbl.pdf	6/10/2014
AP	6/9/2014	SLR	39511	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020083Orig1s053,020657Orig1s032ltr.pdf	6/11/2014
AP	4/11/2014	SCM
AP	6/13/2014	SCM
AP	4/16/2015	SLR	42561	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020083Orig1s058,020657Orig1s033ltr.pdf	4/17/2015
AP	4/16/2015	SLR	42564	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020083s058,020657s033lbl.pdf	4/17/2015
AP	9/29/2016	SCM

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