Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207947
Company: ACTELION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UPTRAVI SELEXIPAG 0.2MG TABLET;ORAL Prescription None Yes No
UPTRAVI SELEXIPAG 0.4MG TABLET;ORAL Prescription None Yes Yes
UPTRAVI SELEXIPAG 0.6MG TABLET;ORAL Prescription None Yes No
UPTRAVI SELEXIPAG 0.8MG TABLET;ORAL Prescription None Yes No
UPTRAVI SELEXIPAG 1MG TABLET;ORAL Prescription None Yes No
UPTRAVI SELEXIPAG 1.2MG TABLET;ORAL Prescription None Yes No
UPTRAVI SELEXIPAG 1.4MG TABLET;ORAL Prescription None Yes No
UPTRAVI SELEXIPAG 1.6MG TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2015 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207947Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/19/2021 SUPPL-10 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s010ltr.pdf
10/25/2021 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s009ltr.pdf
01/30/2021 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207947Orig1s008ltr.pdf
09/04/2019 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207947s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207947Orig1s007ltr.pdf
12/20/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s005ltr.pdf
09/28/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s003ltr.pdf
07/21/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207947Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2021 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s009lbl.pdf
08/19/2021 SUPPL-10 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf
08/19/2021 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s010lbl.pdf
01/30/2021 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207947s008lbl.pdf
09/04/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207947s007lbl.pdf
12/20/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s005lbl.pdf
09/28/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s003lbl.pdf
07/21/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207947s001lbl.pdf
12/21/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2015/207947s000lbl.pdf

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