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Back to FDA Applications sponsored by ACTELION PHARMS LTD
FDA Drug Application 021290 by ACTELION PHARMS LTD
Application Number
021290
Application Type
New Drug Application
Sponsor Applicant
ACTELION PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
Therapeutic Potential
Standard
Orphan Code
V
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
11/20/2001
N
3998
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer_Approv.pdf
11/20/2001
AP
0
11/20/2001
N
3999
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf
11/20/2001
AP
0
11/20/2001
N
5186
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer.cfm
11/20/2001
AP
0
11/20/2001
N
5587
000
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089801.pdf
5/7/2003
AP
0
11/20/2001
N
35061
000
REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=61
2/4/2013
AP
0
10/6/2003
SE8
6764
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21290se8-001ltr.pdf
10/6/2003
AP
0
10/6/2003
SE8
6785
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8-001_tracleer_lbl.pdf
10/10/2003
AP
0
10/6/2003
SE8
7245
001
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-290S001_Tracleer.cfm
12/15/2003
AP
0
11/24/2004
SLR
10675
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21290s004ltr.pdf
12/2/2004
AP
0
11/29/2005
SE8
13205
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf
12/5/2005
AP
0
11/29/2005
SE8
13220
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf
12/6/2005
AP
0
11/29/2005
SLR
13206
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf
12/5/2005
AP
0
11/29/2005
SLR
13221
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf
12/6/2005
AP
0
2/15/2007
SE8
15866
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf
2/21/2007
AP
0
2/15/2007
SE8
15889
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s010ltr.pdf
2/23/2007
AP
0
6/1/2007
SLR
16665
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s011ltr.pdf
6/4/2007
AP
0
8/7/2009
SE1
23156
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf
8/11/2009
AP
0
8/7/2009
SE1
23157
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012SUMR.pdf
8/11/2009
AP
0
8/7/2009
SE1
23165
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s012ltr.pdf
8/13/2009
AP
0
2/13/2009
SLR
21856
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s014ltr.pdf
2/18/2009
AP
0
2/13/2009
SLR
21888
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf
2/20/2009
AP
0
3/17/2009
SLR
22064
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf
3/20/2009
AP
0
3/17/2009
SLR
22085
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s015ltr.pdf
3/24/2009
AP
0
8/7/2009
SLR
23205
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s016ltr.pdf
8/20/2009
AP
0
8/7/2009
SLR
23396
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf
9/17/2009
AP
0
2/19/2010
SLR
24848
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021290s018ltr.pdf
2/25/2010
AP
0
2/19/2010
SLR
24963
018
REMS
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021290s018REMS.pdf
3/5/2010
AP
0
2/8/2011
SLR
27800
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021290s019lbl.pdf
2/9/2011
AP
0
2/8/2011
SLR
27826
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021290s019ltr.pdf
2/14/2011
AP
0
10/4/2012
SE8
33991
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022mg.pdf
10/5/2012
AP
0
10/4/2012
SE8
33992
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022lbl.pdf
10/5/2012
AP
0
10/4/2012
SE8
33998
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021290Orig1s022ltr.pdf
10/9/2012
AP
0
6/3/2013
SCM
AP
0
7/1/2013
SLR
36440
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf
7/3/2013
AP
0
7/1/2013
SLR
36458
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021290Orig1s025ltr.pdf
7/5/2013
AP
0
12/4/2015
S
44701
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s027s029lbl.pdf
12/8/2015
AP
0
12/4/2015
S
44711
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf
12/9/2015
AP
0
12/4/2015
SLR
44675
029
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf
12/8/2015
AP
0
12/4/2015
SLR
44712
029
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf
12/9/2015
AP
0
10/7/2016
SCM
AP
0
10/20/2016
SLR
47427
033
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s033ltr.pdf
10/21/2016
AP
0
10/20/2016
SLR
47428
033
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021290s033lbl.pdf
10/21/2016
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