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FDA Drug Application 017919 by JANSSEN PHARMS

Application Number	017919
Application Type	New Drug Application
Sponsor Applicant	JANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	6/23/1977	N
AP	3/29/1978	SCS
AP	10/20/1977	SCS
AP	7/31/1978	SCS
AP	5/25/1978	SCS
AP	4/17/1978	SCS
AP	2/28/1978	SCS
AP	2/28/1978	SCS
AP	2/28/1978	SCS
AP	6/19/1979	SCF
AP	10/19/1979	SCP
AP	11/8/1979	SCS
AP	12/5/1979	SLR
AP	12/5/1979	SLR
AP	3/24/1980	SCM
AP	8/21/1980	SCM
AP	11/12/1980	SCS
AP	11/12/1980	SCS
AP	9/29/1982	SLR
AP	6/9/1983	SCS
AP	6/15/1983	SLR
AP	9/29/1983	SLR
AP	1/30/1984	SLR
AP	6/21/1984	SLR
AP	4/5/1985	SLR
AP	10/21/1985	SLR
AP	11/23/1987	SCS
AP	2/26/1987	SLR
AP	9/9/1988	SLR
AP	6/8/1988	SCM
AP	10/28/1988	SCS
AP	7/19/1989	SLR
AP	10/23/1989	SLR
AP	1/18/1990	SCS
AP	9/16/1991	SLR
AP	3/18/1991	SCS
AP	3/7/1994	SCF
AP	5/18/1993	SCS
AP	1/4/1994	SLR
AP	11/4/1993	SCM
AP	2/16/1995	SCS
AP	9/7/1995	SCS
AP	11/30/1995	SCM
AP	5/10/1996	SCS
AP	4/9/1996	SCS
AP	1/29/1997	SCS
AP	2/24/1997	SCS
AP	8/27/1999	SLR
AP	1/6/1999	SLR
AP	4/13/1998	SCM
AP	4/28/1998	SCM
AP	8/27/1999	SLR
AP	1/5/2000	SCP
AP	6/6/2000	SLR
AP	7/9/2001	SCS
AP	2/21/2002	SCM
AP	6/3/2002	SCS
AP	10/2/2013	SLR	37337	086	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf	10/4/2013
AP	10/2/2013	SLR	37360	086	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf	10/4/2013
AP	6/18/2012	SLR	32951	089	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf	6/20/2012
AP	6/18/2012	SLR	33188	089	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf	7/13/2012
AP	10/2/2013	SLR	37348	090	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf	10/4/2013
AP	10/2/2013	SLR	37332	092	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf	10/4/2013
AP	10/2/2013	SLR	37354	096	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf	10/4/2013
AP	9/11/2014	SCM
AP	10/29/2015	SLR	44356	099	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf	11/4/2015
AP	10/29/2015	SLR	44370	099	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf	11/4/2015

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