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 |
| 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 | 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 |