Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209279
Company: ACTELION PHARMS
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
05/16/2019 SUPPL-5 Labeling-Medication Guide, 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
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
05/16/2019 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf
05/16/2019 SUPPL-5 Labeling-Package Insert 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

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