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Back to FDA Applications sponsored by THERAVANCE BIOPHARMA
FDA Drug Application 022110 by THERAVANCE BIOPHARMA
Application Number
022110
Application Type
New Drug Application
Sponsor Applicant
THERAVANCE BIOPHARMA
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
9/11/2009
N
23318
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022110s000ltr.pdf
9/16/2009
AP
0
9/11/2009
N
23405
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022110s000lbl.pdf
9/18/2009
AP
0
9/11/2009
N
23454
000
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf
9/25/2009
AP
0
9/11/2009
N
24155
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000TOC.cfm
11/25/2009
AP
0
9/11/2009
N
24156
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000_SumR.pdf
11/25/2009
AP
0
9/11/2009
N
29651
000
REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65
8/2/2011
AP
0
7/27/2011
SLR
29619
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022110s002ltr_corrected.pdf
7/27/2011
AP
0
6/21/2013
S
36380
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf
6/25/2013
AP
0
6/21/2013
S
36389
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf
6/26/2013
AP
0
2/1/2013
SCM
AP
0
5/31/2013
SCM
AP
0
2/7/2014
SLR
38480
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s007lbl.pdf
2/10/2014
AP
0
12/12/2013
SCM
AP
0
3/13/2014
SCM
38848
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s009lbl.pdf
3/19/2014
AP
0
11/12/2014
S
40985
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s010ltr.pdf
11/14/2014
AP
0
12/3/2014
SLR
41152
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s011ltr.pdf
12/4/2014
AP
0
12/3/2014
SLR
41196
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s011lbl.pdf
12/10/2014
AP
0
5/6/2016
SE8
45887
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s012ltr.pdf
5/9/2016
AP
0
5/6/2016
SE8
45891
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf
5/9/2016
AP
0
3/23/2016
S
45503
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s013ltr.pdf
3/25/2016
AP
0
3/23/2016
S
45520
013
REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65
3/29/2016
Back to FDA Applications sponsored by THERAVANCE BIOPHARMA