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Back to FDA Applications sponsored by JANSSEN PHARMS
FDA Drug Application 022264 by JANSSEN PHARMS
Application Number
022264
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
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
7/31/2009
N
23199
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022264s000ltr.pdf
8/17/2009
AP
0
7/31/2009
N
23519
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022264lbl.pdf
10/1/2009
AP
0
7/31/2009
N
25543
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264_invega_sustenna_toc.cfm
5/13/2010
AP
0
7/31/2009
N
25544
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000sumr.pdf
5/13/2010
AP
0
7/31/2009
N
31197
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm
12/22/2011
AP
0
5/13/2010
SLR
25563
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s001lbl.pdf
5/17/2010
AP
0
5/13/2010
SLR
25580
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s001ltr.pdf
5/18/2010
AP
0
6/15/2011
SLR
29200
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s002lbl.pdf
6/16/2011
AP
0
6/15/2011
SLR
29256
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s002ltr.pdf
6/24/2011
AP
0
12/1/2010
SLR
27174
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s004lbl.pdf
12/4/2010
AP
0
12/1/2010
SLR
27248
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s004ltr.pdf
12/7/2010
AP
0
8/29/2012
SE8
33598
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022264Orig1s005ltr.pdf
8/30/2012
AP
0
8/29/2012
SE8
33609
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022264s005lbl.pdf
8/31/2012
AP
0
9/24/2011
SLR
30118
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s006ltr.pdf
9/28/2011
AP
0
9/24/2011
SLR
30160
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s006lbl.pdf
9/30/2011
AP
0
4/29/2014
SLR
39185
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf
5/1/2014
AP
0
4/29/2014
SLR
39206
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s010lbl.pdf
5/2/2014
AP
0
8/26/2013
SCM
AP
0
8/25/2014
SCM
AP
0
11/12/2014
SES
40987
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf
11/14/2014
AP
0
11/12/2014
SES
41346
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf
12/20/2014
AP
0
11/12/2014
SES
40986
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf
11/14/2014
AP
0
11/12/2014
SES
41347
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf
12/20/2014
AP
0
6/16/2015
SCM
AP
0
6/9/2015
SLR
43034
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022264Orig1s018ltr.pdf
6/10/2015
AP
0
6/9/2015
SLR
43043
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022264s018lbl.pdf
6/11/2015
AP
0
3/1/2016
SLR
45338
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf
3/3/2016
AP
0
3/1/2016
SLR
45353
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf
3/3/2016
AP
0
8/29/2016
SCM
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