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FDA Drug Application 018701 by JANSSEN PHARMS

Application Number	018701
Application Type	New Drug Application
Sponsor Applicant	JANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New ester, new salt, or other noncovalent derivative
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/14/1986	N
AP	6/10/1986	SCS
AP	2/24/1987	SLR
AP	6/15/1987	SCM
AP	6/15/1987	SCM
AP	6/15/1987	SLR
AP	10/28/1986	SLR
AP	1/28/1987	SCM
AP	1/28/1987	SLR
AP	1/28/1987	SCM
AP	1/28/1987	SLR
AP	11/18/1986	SLR
AP	8/24/1988	SCM
AP	8/24/1988	SCM
AP	9/28/1987	SLR
AP	6/17/1988	SCM
AP	1/18/1989	SCS
AP	1/18/1989	SCS
AP	10/20/1988	SCM
AP	10/20/1988	SLR
AP	1/19/1989	SLR
AP	1/31/1997	SCM
AP	1/31/1997	SLR
AP	2/16/1989	SCP
AP	5/10/1989	SCM
AP	10/31/1989	SLR
AP	12/21/1990	SCM
AP	4/21/1993	SLR
AP	6/29/1994	SCS
AP	4/27/1993	SLR
AP	5/22/1995	SCM
AP	9/7/1994	SCM
AP	5/10/1996	SCM
AP	9/11/1997	SCM
AP	6/23/1998	SCP
AP	5/2/2000	SLR
AP	4/13/2000	SCM
AP	4/17/2002	SLR	17046	046	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018701_S046_HALDOL_TABLETS_AP.pdf	7/6/2007
AP	5/4/2007	SLR	16438	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf	5/7/2007
AP	5/4/2007	SLR	16483	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s078, 018701s053ltr.pdf	5/9/2007
AP	8/12/2011	SLR	29783	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf	8/15/2011
AP	8/12/2011	SLR	29791	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf	8/16/2011
AP	9/19/2007	SLR	17943	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080, 018701s055ltr.pdf	9/25/2007
AP	5/13/2008	SLR	19826	056	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056ltr.pdf	5/14/2008
AP	5/13/2008	SLR	19944	056	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf	6/5/2008
AP	8/14/2008	SLR	20620	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082, 018701s057ltr.pdf	8/19/2008
AP	8/14/2008	SLR	20708	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf	8/29/2008
AP	7/19/2009	SLR	23024	059	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf	7/23/2009
AP	7/19/2009	SLR	23114	059	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf	8/4/2009
AP	12/1/2010	SLR	27188	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018701s062lbl.pdf	12/4/2010
AP	12/1/2010	SLR	27201	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf	12/6/2010
AP	3/1/2011	SLR	28087	063	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf	3/4/2011
AP	3/1/2011	SLR	28095	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063ltr.pdf	3/7/2011
AP	5/6/2013	SLR	35976	065	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701Orig1s065ltr.pdf	5/7/2013
AP	5/24/2013	SCM
AP	6/5/2013	SCM
AP	12/19/2013	SCM
AP	5/18/2016	SLR	46072	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701Orig1s072ltr.pdf	5/20/2016
AP	5/18/2016	SLR	46092	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf	5/20/2016

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