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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214275
Company: ACTELION

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UPTRAVI SELEXIPAG 1.8MG/VIAL POWDER;INTRAVENOUS 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
07/29/2021 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214275s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214275Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214275Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2026 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214275s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/207947Orig1s014; s015; 214275Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/23/2026 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214275s002lbl.pdf
07/29/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214275s000lbl.pdf
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