`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021290
`Company: ACTELION PHARMS LTD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021290)
`
`Medication Guide (http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022mg.pdf)
`
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
`event=IndvRemsDetails.page&REMS=61)
`
`Products on NDA 021290
`
`CSVExcelPrint
`
`Drug Name
`
`Active
`Ingredients
`
`TRACLEER
`
`BOSENTAN
`
`BOSENTAN
`TRACLEER
`Showing 1 to 2 of 2 entries
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`Strength
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`62.5MG
`
`125MG
`
`Dosage
`Form/Route
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Marketing
`Status
`
`Prescription
`
`Prescription
`
`TE
`Code
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`None
`
`None
`
`RLD
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021290
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`11/20/2001 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`STANDARD
`;
`Orphan
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21290_Tracleer_Approv.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21290_Tracleer.cfm)
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`Showing 1 to 1 of 1 entries
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`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`12/16/2016 SUPPL30
`
`REMSModified
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s030ltr.pdf)
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`10/20/2016 SUPPL33
`
`12/04/2015 SUPPL29
`
`Labeling
`Package Insert
`
`Labeling
`Package Insert
`
`12/04/2015 SUPPL27
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`REMSModified
`
`07/01/2013 SUPPL25
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`REMSModified
`
`06/03/2013 SUPPL24
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021290s033lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s033ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s027s029lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021290Orig1s025ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`10/04/2012 SUPPL22
`
`02/08/2011
`
`SUPPL19
`
`Efficacy
`Labeling
`Change With
`Clinical Data
`
`Labeling
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021290Orig1s022ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021290s019lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021290s019ltr.pdf)
`
`02/19/2010 SUPPL18
`
`REMSModified
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021290s018ltr.pdf)
`
`08/07/2009 SUPPL16
`
`08/07/2009 SUPPL12
`
`REMS
`Proposal,
`Labeling
`
`EfficacyNew
`Indication
`
`03/17/2009 SUPPL15
`
`Labeling
`
`02/13/2009 SUPPL14
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s016ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s012ltr.pdf)
`Summary Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012SUMR.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s015ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s014ltr.pdf)
`
`06/01/2007 SUPPL11
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s011ltr.pdf)
`
`02/15/2007 SUPPL10
`
`Efficacy
`Labeling
`Change With
`Clinical Data
`
`11/29/2005
`
`SUPPL7
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s010ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`11/29/2005
`
`SUPPL6
`
`Efficacy
`Labeling
`Change With
`Clinical Data
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf)
`
`11/24/2004
`
`SUPPL4
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21290s004ltr.pdf)
`
`10/06/2003 SUPPL1
`
`Efficacy
`Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8
`001_tracleer_lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21290se8
`001ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21290S001_Tracleer.cfm)
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`Showing 1 to 19 of 19 entries
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`Labels for NDA 021290
`
`
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