Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021290
Company: ACTELION PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRACLEER BOSENTAN 62.5MG TABLET;ORAL Prescription AB Yes No
TRACLEER BOSENTAN 125MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/20/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2019 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021290Orig1s039, 209279Orig1s005ltr.pdf
10/25/2018 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021290s037,209279s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209279Orig1s002,021290Orig1s037ltr.pdf
10/20/2017 SUPPL-35 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s035,209279Orig1s001Ltr.pdf
09/05/2017 SUPPL-34 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021290s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s034ltr.pdf
10/20/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021290s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s033ltr.pdf
04/26/2019 SUPPL-32 REMS - MODIFIED - D-N-A, REMS - MODIFIED - BIFURCATED Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s032,209279s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021290Orig1s032; 209279Orig1s004ltr.pdf
12/16/2016 SUPPL-30 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s030ltr.pdf
12/04/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf
12/04/2015 SUPPL-27 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s027s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf
07/01/2013 SUPPL-25 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021290Orig1s025ltr.pdf
06/03/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/04/2012 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021290Orig1s022ltr.pdf
02/08/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021290s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021290s019ltr.pdf
02/19/2010 SUPPL-18 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021290s018ltr.pdf
08/07/2009 SUPPL-16 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s016ltr.pdf
03/17/2009 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s015ltr.pdf
02/13/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s014ltr.pdf
08/07/2009 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012SUMR.pdf
06/01/2007 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s011ltr.pdf
02/15/2007 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s010ltr.pdf
11/29/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf
11/29/2005 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf
11/24/2004 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21290s004ltr.pdf
10/06/2003 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8-001_tracleer_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21290se8-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-290S001_Tracleer.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2019 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf
04/26/2019 SUPPL-32 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s032,209279s004lbl.pdf
04/26/2019 SUPPL-32 REMS - MODIFIED - BIFURCATED Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s032,209279s004lbl.pdf
10/25/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021290s037,209279s002lbl.pdf
09/05/2017 SUPPL-34 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021290s034lbl.pdf
10/20/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021290s033lbl.pdf
12/04/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf
12/04/2015 SUPPL-27 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s027s029lbl.pdf
07/01/2013 SUPPL-25 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf
10/04/2012 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022lbl.pdf
02/08/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021290s019lbl.pdf
08/07/2009 SUPPL-16 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf
08/07/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf
08/07/2009 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf
03/17/2009 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf
02/13/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf
02/15/2007 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf
11/29/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf
11/29/2005 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf
10/06/2003 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8-001_tracleer_lbl.pdf
11/20/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf

TRACLEER

TABLET;ORAL; 62.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 206002 ALVOGEN PINE BROOK
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 209742 AMNEAL PHARMS CO
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 206987 NATCO PHARMA LTD
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 205699 PAR PHARM INC
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 209324 SUN PHARM
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 207110 WATSON LABS INC
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 208695 WEST-WARD PHARMS INT
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 207760 ZYDUS PHARMS
TRACLEER BOSENTAN 62.5MG TABLET;ORAL Prescription Yes AB 021290 ACTELION PHARMS LTD

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 206002 ALVOGEN PINE BROOK
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 209742 AMNEAL PHARMS CO
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 206987 NATCO PHARMA LTD
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 205699 PAR PHARM INC
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 209324 SUN PHARM
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 207110 WATSON LABS INC
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 208695 WEST-WARD PHARMS INT
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 207760 ZYDUS PHARMS
TRACLEER BOSENTAN 125MG TABLET;ORAL Prescription Yes AB 021290 ACTELION PHARMS LTD

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