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Back to FDA Applications sponsored by JANSSEN PRODS
FDA Drug Application 202895 by JANSSEN PRODS
Application Number
202895
Application Type
New Drug Application
Sponsor Applicant
JANSSEN PRODS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
12/16/2011
N
31240
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf
12/23/2011
AP
0
12/16/2011
N
31268
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf
12/27/2011
AP
0
12/16/2011
N
33662
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895_prezista_toc.cfm
9/6/2012
AP
0
12/16/2011
N
33663
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895Orig1s000SumR.pdf
9/6/2012
AP
0
2/17/2012
SLR
31968
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895s001ltr.pdf
2/29/2012
AP
0
2/17/2012
SLR
32116
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s001lbl.pdf
3/15/2012
AP
0
6/1/2012
SLR
32814
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf
6/5/2012
AP
0
6/1/2012
SLR
32843
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf
6/7/2012
AP
0
11/9/2012
SLR
34370
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895Orig1s003ltr.pdf
11/14/2012
AP
0
11/9/2012
SLR
34395
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s003lbl.pdf
11/15/2012
AP
0
4/24/2013
SE8
35845
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf
4/25/2013
AP
0
4/24/2013
SE8
35869
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf
4/29/2013
AP
0
2/1/2013
SE8
35063
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf
2/4/2013
AP
0
2/1/2013
SE8
35085
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf
2/6/2013
AP
0
2/1/2013
SE8
35065
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf
2/4/2013
AP
0
2/1/2013
SE8
35082
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf
2/6/2013
AP
0
2/22/2013
SLR
35238
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf
2/26/2013
AP
0
2/22/2013
SLR
35254
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf
2/26/2013
AP
0
6/14/2013
SCM
AP
0
11/7/2013
SLR
37768
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf
11/8/2013
AP
0
11/7/2013
SLR
37776
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf
11/8/2013
AP
0
4/7/2014
SLR
38997
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf
4/8/2014
AP
0
4/7/2014
SLR
39011
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf
4/8/2014
AP
0
5/8/2014
SCM
AP
0
5/27/2015
SLR
42937
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf
5/28/2015
AP
0
5/27/2015
SLR
42939
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf
5/29/2015
AP
0
3/27/2015
SLR
42354
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf
4/1/2015
AP
0
3/27/2015
SLR
42399
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf
4/2/2015
AP
0
6/17/2016
SE8
46365
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf
6/21/2016
AP
0
6/17/2016
SE8
46386
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf
6/21/2016
AP
0
9/15/2016
SLR
47088
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf
9/20/2016
AP
0
9/15/2016
SLR
47109
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf
9/20/2016
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