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Back to FDA Applications sponsored by CONCORDIA PHARMS INC
FDA Drug Application 021287 by CONCORDIA PHARMS INC
Application Number
021287
Application Type
New Drug Application
Sponsor Applicant
CONCORDIA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
6/12/2003
N
5975
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287ltr.pdf
6/22/2003
AP
0
6/12/2003
N
5987
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf
6/22/2003
AP
0
6/12/2003
N
6624
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_uroxatral_toc.cfm
9/9/2003
AP
0
7/15/2003
SLR
6165
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287slr001ltr.pdf
7/28/2003
AP
0
7/15/2003
SLR
15642
001
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_S001_UROXATRALTOC.cfml
1/10/2007
AP
0
3/17/2006
SLR
13775
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf
3/22/2006
AP
0
3/17/2006
SLR
13799
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s005ltr.pdf
3/23/2006
AP
0
11/16/2006
SLR
15378
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf
11/22/2006
AP
0
11/16/2006
SLR
15390
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s007ltr.pdf
11/22/2006
AP
0
3/29/2007
SLR
16123
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf
3/31/2007
AP
0
3/29/2007
SLR
16178
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021287s008ltr.pdf
4/9/2007
AP
0
5/6/2008
SLR
19798
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s009ltr.pdf
5/9/2008
AP
0
9/18/2008
SLR
20865
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf
9/19/2008
AP
0
9/18/2008
SLR
20873
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s011ltr.pdf
9/23/2008
AP
0
5/20/2009
SLR
22613
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf
5/25/2009
AP
0
5/20/2009
SLR
22630
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021287s013ltr.pdf
5/27/2009
AP
0
4/9/2010
SLR
25258
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s014ltr.pdf
4/13/2010
AP
0
4/9/2010
SLR
25303
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf
4/19/2010
AP
0
12/15/2010
SE8
27295
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf
12/16/2010
AP
0
12/15/2010
SE8
27306
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s016ltr.pdf
12/21/2010
AP
0
5/30/2013
SLR
36167
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021287Orig1s017ltr.pdf
5/31/2013
AP
0
5/30/2013
SLR
36213
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf
6/4/2013
AP
0
4/21/2014
SLR
39120
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf
4/22/2014
AP
0
4/21/2014
SLR
40170
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021287Orig1s018ltr.pdf
8/6/2014
AP
0
3/23/2016
SCM
AP
0
10/18/2016
SCM
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