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Back to FDA Applications sponsored by SCHERING
FDA Drug Application 022003 by SCHERING
Application Number
022003
Application Type
New Drug Application
Sponsor Applicant
SCHERING
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
9/15/2006
N
14839
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022003lbl.pdf
9/18/2006
AP
0
9/15/2006
N
14898
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022003ltr.pdf
9/20/2006
AP
0
9/15/2006
N
15338
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022003s000_NoxafilTOC.cfm
11/9/2006
AP
0
5/20/2008
SLR
19871
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf
5/21/2008
AP
0
5/20/2008
SLR
19872
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf
5/21/2008
AP
0
2/19/2009
SLR
21892
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022003s007lbl.pdf
2/20/2009
AP
0
2/19/2009
SLR
21900
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022003s007ltr.pdf
2/23/2009
AP
0
9/8/2010
SLR
26447
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf
9/10/2010
AP
0
9/8/2010
SLR
26478
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf
9/13/2010
AP
0
6/21/2012
SLR
32982
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf
6/22/2012
AP
0
6/21/2012
SLR
32987
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf
6/25/2012
AP
0
6/21/2012
SLR
32983
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf
6/22/2012
AP
0
6/21/2012
SLR
32988
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf
6/25/2012
AP
0
1/7/2014
SCM
AP
0
6/16/2014
SCM
AP
0
6/15/2015
SCM
AP
0
7/14/2015
SLR
43389
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s016ltr.pdf
7/16/2015
AP
0
7/14/2015
SLR
43441
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003Orig1s016lbl.pdf
7/22/2015
AP
0
8/13/2015
SCM
AP
0
11/16/2015
SLR
44500
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf
11/18/2015
AP
0
11/16/2015
SLR
44541
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/19/2015
AP
0
4/11/2016
SCM
AP
0
11/16/2015
SLR
44501
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf
11/18/2015
AP
0
11/16/2015
SLR
44542
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/19/2015
AP
0
9/9/2016
SLR
47032
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf
9/12/2016
AP
0
9/9/2016
SLR
47040
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf
9/15/2016
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