← FDA DRUG APPROVALS

FDA NDA · NDA209279

TRACLEER

bosentan

Sponsor: ACTELION

APPLICATION
NDA209279
TYPE
NDA
ORIGINAL APPROVAL
2017-09-05
LATEST ACTION
2026-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

TRACLEER · ReferencePrescription
BOSENTAN 32MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2026-03-03REMS · Supplement 17 — Letter ↗AP
2025-11-05Labeling · Supplement 15 — Letter ↗AP
2025-07-30Labeling · Supplement 14 · standard — Letter ↗AP
2025-02-21REMS · Supplement 12AP
2024-09-17REMS · Supplement 11 — Letter ↗AP
2024-02-08Labeling · Supplement 10 · standard — Label ↗AP
2022-04-29REMS · Supplement 9 — Letter ↗AP
2021-07-29Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2019-05-16Labeling · Supplement 5 · standard — Letter ↗AP
2019-04-26REMS · Supplement 4 — Letter ↗AP
2018-10-25Labeling · Supplement 2 · standard — Label ↗AP
2017-10-20REMS · Supplement 1 — Letter ↗AP
2017-09-05Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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