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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218490
Company: ACTELION

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPSYNVI MACITENTAN; TADALAFIL 10MG;20MG TABLET;ORAL Prescription None Yes No
OPSYNVI MACITENTAN; TADALAFIL 10MG;40MG TABLET;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
03/22/2024 ORIG-1 Approval Type 4 - New Combination STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218490s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218490Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218490Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2025 SUPPL-2 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218490s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204410Orig1s031; 218490Orig1s002ltr.pdf
12/12/2024 SUPPL-1 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204410Orig1s030;218490Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/02/2025 SUPPL-2 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218490s002lbl.pdf
03/22/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218490s000lbl.pdf
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