Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209279
Company: ACTELION
Company: ACTELION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRACLEER | BOSENTAN | 32MG | TABLET, FOR SUSPENSION;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
09/05/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209279s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/2024 | SUPPL-10 | 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-9 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021290Orig1s043, 209279Orig1s009ltr.pdf |
07/29/2021 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209279Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209279Orig1s008ltr.pdf | |
05/16/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
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 | |
04/26/2019 | SUPPL-4 | 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 | |
10/25/2018 | SUPPL-2 | 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-1 | REMS - MODIFIED - D-N-A |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021290Orig1s035,209279Orig1s001Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/08/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021290s044,209279s010lbl.pdf | |
07/29/2021 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209279Orig1s008lbl.pdf | |
05/16/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf | |
05/16/2019 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf | |
04/26/2019 | SUPPL-4 | REMS - MODIFIED - BIFURCATED | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s032,209279s004lbl.pdf | |
10/25/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021290s037,209279s002lbl.pdf | |
09/05/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209279s000lbl.pdf |