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Back to FDA Applications sponsored by ACTELION PHARMS LTD
FDA Drug Application 021779 by ACTELION PHARMS LTD
Application Number
021779
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
Priority
Orphan Code
V
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
12/29/2004
N
10918
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021779ltr.pdf
1/11/2005
AP
0
12/29/2004
N
10942
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021779lbl.pdf
1/11/2005
AP
0
12/29/2004
N
11290
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-779_Ventavis.cfm
3/28/2005
AP
0
8/24/2005
SE1
12670
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf
8/31/2005
AP
0
8/24/2005
SE1
12688
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf
8/31/2005
AP
0
8/24/2005
SCF
12671
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf
8/31/2005
AP
0
8/24/2005
SCF
12689
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf
8/31/2005
AP
0
12/8/2005
SCS
13256
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s003lbl.pdf
12/15/2005
AP
0
12/8/2005
SCS
13269
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s003ltr.pdf
12/15/2005
AP
0
3/4/2008
SLR
19358
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s006lbl.pdf
3/5/2008
AP
0
3/4/2008
SLR
19397
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s006ltr.pdf
3/7/2008
AP
0
9/22/2008
SLR
20875
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s008ltr.pdf
9/23/2008
AP
0
9/22/2008
SLR
20882
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s008lbl.pdf
9/25/2008
AP
0
8/7/2009
SCM
23436
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf
9/22/2009
AP
0
8/7/2009
SCM
24650
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021779s009ltr.pdf
1/27/2010
AP
0
8/7/2009
SCM
30818
009
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021779Orig1s009.pdf
10/10/2011
AP
0
4/20/2010
SLR
25338
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021779s010ltr.pdf
4/23/2010
AP
0
4/20/2010
SLR
25436
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021779s010lbl.pdf
5/3/2010
AP
0
2/8/2011
SLR
27801
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021779s012lbl.pdf
2/9/2011
AP
0
2/8/2011
SLR
27827
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021779s012ltr.pdf
2/14/2011
AP
0
4/26/2012
SLR
32574
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021779s013lbl.pdf
5/1/2012
AP
0
4/26/2012
SLR
32584
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021779Orig1s013ltr.pdf
5/2/2012
AP
0
11/22/2013
SLR
37906
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021779Orig1s014ltr_corrected.pdf
11/25/2013
AP
0
11/22/2013
SLR
37933
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021779s014lbl.pdf
11/26/2013
AP
0
11/10/2014
SCM
AP
0
1/5/2015
SCM
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