FDA.reportPublic FDA data

Application 021290

Type
NDA
Sponsor
ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRACLEERBOSENTANTABLET;ORAL62.5MGYesNo
002TRACLEERBOSENTANTABLET;ORAL125MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10148-125bosentanbosentanCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-125bosentanbosentanCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-625bosentanbosentanCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-625bosentanbosentanCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-101TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent
66215-102TracleerbosentanActelion Pharmaceuticals US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85267SUPPL 2026-03-04
84133SUPPL 2025-11-12
84134SUPPL 2025-11-10
84083SUPPL 2025-11-06
83012SUPPL 2025-08-01
83004SUPPL 2025-07-31
79653SUPPL 2024-09-19
77457SUPPL 2024-02-09
77428SUPPL 2024-02-09
76400ORIG 2023-11-06
74456SUPPL 2023-06-07
74455SUPPL 2023-06-07
71490SUPPL2022-06-30
70934SUPPL2022-05-03
63026SUPPL2020-05-15
63015SUPPL2020-05-15
58800SUPPL2019-05-20
58797SUPPL2019-05-20
58770SUPPL2019-05-17
58507SUPPL2019-05-01
58478SUPPL2019-04-30
56184SUPPL2018-10-30
56109SUPPL2018-10-26
49671SUPPL2017-12-29
49711SUPPL2017-09-11
49684SUPPL2017-09-07
46449SUPPL2016-12-21
45578SUPPL2016-10-21
45572SUPPL2016-10-21
4945SUPPL2015-12-09
4944SUPPL2015-12-09
36599SUPPL2015-12-08
15124SUPPL2015-12-08
27403SUPPL2013-07-05
15123SUPPL2013-07-03
23990ORIG2013-02-04
4943SUPPL2012-10-09
36598SUPPL2012-10-05
27402SUPPL2011-02-14
36597SUPPL2011-02-09
27401SUPPL2010-02-25
15122SUPPL2009-09-17
27400SUPPL2009-08-20
4941SUPPL2009-08-13
36596SUPPL2009-08-11
24190SUPPL2009-08-11
27399SUPPL2009-03-24
14909SUPPL2009-03-20
14908SUPPL2009-02-20
4942SUPPL2009-02-18
27398SUPPL2007-06-04
4940SUPPL2007-02-23
14907SUPPL2007-02-21
4939SUPPL2005-12-06
4938SUPPL2005-12-06
36595SUPPL2005-12-05
14906SUPPL2005-12-05
27397SUPPL2004-12-02
42085SUPPL2003-12-15
14905SUPPL2003-10-10
4937SUPPL2003-10-06
27396ORIG2001-11-20
21578ORIG2001-11-20
14904ORIG2001-11-20