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FDA NDA · NDA214275

UPTRAVI

selexipag

Sponsor: ACTELION

APPLICATION
NDA214275
TYPE
NDA
ORIGINAL APPROVAL
2021-07-29
LATEST ACTION
2026-05-23
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

UPTRAVI · ReferencePrescription
SELEXIPAG 1.8MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-05-23Labeling · Supplement 2 · standardLetterAP
2021-07-29Type 3 - New Dosage Form · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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