Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021290
Company: ACTELION
Company: ACTELION
| 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 |
|---|---|---|---|---|---|
| 02/08/2024 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021290s044,209279s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021290Orig1s044, 209279Orig1s010ltr.pdf | |
| 04/29/2022 | SUPPL-43 | REMS - MODIFIED - D-N-A |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021290Orig1s043, 209279Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021290Orig1s043.pdf |
| 06/06/2023 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021290Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021290Orig1s042ltr.pdf | |
| 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 | |
| 10/02/2012 | SUPPL-20 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021290Orig1s020ltr.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 | Labeling, REMS-Proposal |
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 |
|---|---|---|---|---|---|
| 02/08/2024 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021290s044,209279s010lbl.pdf | |
| 06/06/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021290Orig1s042lbl.pdf | |
| 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 | |
| 10/02/2012 | SUPPL-20 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290Orig1s020lbl.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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.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-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 | 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 | 207760 | ZYDUS PHARMS |
| TRACLEER | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | Yes | AB | 021290 | ACTELION |
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 | 209324 | SUN PHARM |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 207110 | WATSON LABS INC |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 207760 | ZYDUS PHARMS |
| TRACLEER | BOSENTAN | 125MG | TABLET;ORAL | Prescription | Yes | AB | 021290 | ACTELION |