FDA Drug Application 018533 by JANSSEN PHARMS

Application Number	018533
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	6/12/1981	N	36602	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf	7/25/2013
AP	6/12/1981	N	38467	000	http://www.fda.gov/drugs/drugsafety/ucm362415.htm	2/7/2014
AP	9/29/1981	SCM
AP	6/23/1983	SLR
AP	6/30/1986	SLR
AP	6/23/1983	SLR
AP	4/15/1983	SCM
AP	4/15/1983	SCM
AP	9/8/1983	SCS
AP	7/9/1984	SCM
AP	7/9/1984	SCM
AP	6/30/1986	SLR
AP	6/30/1986	SLR
AP	6/30/1986	SLR
AP	6/30/1986	SLR
AP	6/19/1985	SCP
AP	5/10/1988	SCE
AP	7/8/1988	SCS
AP	4/14/1989	SLR
AP	3/15/1991	SLR
AP	12/28/1992	SLR
AP	10/13/1992	SCM
AP	12/28/1992	SLR
AP	9/20/1993	SCM
AP	3/22/1994	SLR
AP	9/8/1995	SCS
AP	9/8/1995	SCM
AP	9/15/1995	SCM
AP	7/8/1996	SLR
AP	4/8/1996	SCM
AP	6/14/1996	SCS
AP	3/17/1998	SCM
AP	5/28/1998	SCS
AP	7/24/1998	SCP
AP	4/13/1999	SCM
AP	9/17/1999	SCP
AP	4/1/2002	SCS
AP	8/13/2002	SCE
AP	7/25/2013	SLR	36601	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf	7/25/2013
AP	7/25/2013	SLR	36636	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018533Orig1s040ltr.pdf	7/29/2013
AP	2/25/2014	SLR	38607	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018533Orig1s041ltr.pdf	2/27/2014
AP	2/25/2014	SLR	38666	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf	3/5/2014

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