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Back to FDA Applications sponsored by GILEAD
FDA Drug Application 021937 by GILEAD
Application Number
021937
Application Type
New Drug Application
Sponsor Applicant
GILEAD
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New combination
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
7/12/2006
N
14440
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021937lbl.pdf
7/12/2006
AP
0
7/12/2006
N
14512
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021937s000ltr.pdf
7/21/2006
AP
0
7/12/2006
N
15455
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021937TOC2.cfm
12/13/2006
AP
0
2/15/2008
SLR
19238
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s006ltr.pdf
2/20/2008
AP
0
2/15/2008
SLR
19275
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s006lbl.pdf
2/25/2008
AP
0
2/28/2008
SLR
19351
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s007ltr.pdf
3/4/2008
AP
0
2/28/2008
SLR
19374
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s007lbl.pdf
3/5/2008
AP
0
6/6/2008
SE8
19970
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s009ltr.pdf
6/9/2008
AP
0
6/6/2008
SE8
19998
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021937s009lbl.pdf
6/12/2008
AP
0
10/18/2008
SCP
21067
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021937s011ltr.pdf
10/23/2008
AP
0
1/7/2010
SE8
24474
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s012lbl.pdf
1/8/2010
AP
0
1/7/2010
SE8
24522
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s012ltr.pdf
1/15/2010
AP
0
8/6/2010
SLR
26179
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021937s019lbl.pdf
8/10/2010
AP
0
8/6/2010
SLR
26201
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021937s019ltr.pdf
8/11/2010
AP
0
9/16/2011
SLR
30036
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021937s023ltr.pdf
9/20/2011
AP
0
9/16/2011
SLR
30050
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021937s023lbl.pdf
9/20/2011
AP
0
6/14/2012
SLR
32917
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021937s025ltr.pdf
6/18/2012
AP
0
6/14/2012
SLR
32926
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021937s025lbl.pdf
6/18/2012
AP
0
4/17/2013
SLR
35759
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s027lbl.pdf
4/19/2013
AP
0
4/17/2013
SLR
35763
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s027ltr.pdf
4/23/2013
AP
0
11/8/2013
SCM
AP
0
10/23/2013
SLR
37553
031
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021937Orig1s031ltr.pdf
10/25/2013
AP
0
10/23/2013
SLR
37571
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021937s031lbl.pdf
10/25/2013
AP
0
7/11/2014
SCM
AP
0
11/26/2014
SCM
AP
0
1/23/2015
SLR
41678
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s034ltr.pdf
1/26/2015
AP
0
1/23/2015
SLR
41727
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s034lbl.pdf
1/29/2015
AP
0
1/12/2015
SCM
AP
0
11/20/2015
SLR
44558
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021937Orig1s037ltr.pdf
11/23/2015
AP
0
11/20/2015
SLR
44656
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021937s037lbl.pdf
12/3/2015
AP
0
2/11/2016
SLR
45163
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021937Orig1s039ltr.pdf
2/12/2016
AP
0
2/11/2016
SLR
45185
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021937s039lbl.pdf
2/18/2016
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