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Back to FDA Applications sponsored by UNITED THERAP
FDA Drug Application 021272 by UNITED THERAP
Application Number
021272
Application Type
New Drug Application
Sponsor Applicant
UNITED THERAP
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
5/21/2002
N
3153
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21272ini.pdf
5/21/2002
AP
0
5/21/2002
N
3154
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf
5/21/2002
AP
0
5/21/2002
N
3155
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-272_Remodulin.cfm
7/31/2002
AP
0
11/24/2004
SE3
30829
002
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021272Orig1s002.pdf
10/10/2011
AP
0
1/20/2006
SLR
13549
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272s003ltr.pdf
1/30/2006
AP
0
3/20/2006
SE7
13774
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf
3/22/2006
AP
0
3/20/2006
SE7
13792
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272S005ltr.pdf
3/23/2006
AP
0
3/20/2006
SE7
44513
005
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021272Orig1s005.pdf
11/18/2015
AP
0
9/12/2008
SLR
20773
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf
9/16/2008
AP
0
9/12/2008
SLR
20855
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf
9/19/2008
AP
0
2/4/2008
SLR
19067
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s009ltr.pdf
2/7/2008
AP
0
2/4/2008
SLR
19132
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf
2/14/2008
AP
0
1/8/2010
SLR
24500
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf
1/12/2010
AP
0
1/8/2010
SLR
24518
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021272s011ltr.pdf
1/15/2010
AP
0
2/8/2011
SLR
27798
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf
2/9/2011
AP
0
2/8/2011
SLR
27825
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021272s015ltr.pdf
2/14/2011
AP
0
12/22/2014
SLR
41433
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021272Orig1s019ltr.pdf
12/30/2014
AP
0
12/22/2014
SLR
47172
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf
9/27/2016
AP
0
9/24/2013
SLR
37231
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf
9/26/2013
AP
0
9/24/2013
SLR
37240
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf
9/27/2013
AP
0
9/24/2013
SLR
37251
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf
9/27/2013
AP
0
9/24/2013
SLR
37268
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf
10/1/2013
AP
0
9/24/2013
SLR
38292
020
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf
1/16/2014
AP
1
9/26/2013
SLR
37231
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf
9/26/2013
AP
1
9/26/2013
SLR
37240
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf
9/27/2013
AP
1
9/26/2013
SLR
37251
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf
9/27/2013
AP
1
9/26/2013
SLR
37268
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf
10/1/2013
AP
1
9/26/2013
SLR
38292
020
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf
1/16/2014
AP
0
1/3/2014
SCM
AP
0
1/22/2016
SCM
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