← FDA DRUG APPROVALS

FDA NDA · NDA021290

TRACLEER

bosentan

Sponsor: ACTELION

APPLICATION
NDA021290
TYPE
NDA
ORIGINAL APPROVAL
2001-11-20
LATEST ACTION
2026-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRACLEER · ReferencePrescription
BOSENTAN 62.5MG · TABLET · ORAL
TRACLEER · ReferencePrescription
BOSENTAN 125MG · TABLET · ORAL

Approval history

2026-03-03REMS · Supplement 50 — Letter ↗AP
2025-11-05Labeling · Supplement 48 — Letter ↗AP
2025-07-30Labeling · Supplement 47 · standard — Label ↗AP
2025-02-21REMS · Supplement 46AP
2024-09-17REMS · Supplement 45 — Letter ↗AP
2024-02-08Labeling · Supplement 44 · standard — Label ↗AP
2023-06-06Labeling · Supplement 42 · standard — Label ↗AP
2022-04-29REMS · Supplement 43 — Letter ↗AP
2019-05-16Labeling · Supplement 39 · standard — Letter ↗AP
2019-04-26REMS · Supplement 32 — Letter ↗AP
2018-10-25Labeling · Supplement 37 · standard — Label ↗AP
2017-10-20REMS · Supplement 35 — Letter ↗AP
2017-09-05REMS · Supplement 34 — Label ↗AP
2016-12-16REMS · Supplement 30 — Letter ↗AP
2016-10-20Labeling · Supplement 33 · standard — Letter ↗AP
2015-12-04Labeling · Supplement 29 · standard — Letter ↗AP
2015-12-04REMS · Supplement 27 — Letter ↗AP
2013-07-01REMS · Supplement 25 — Label ↗AP
2013-06-03Manufacturing (CMC) · Supplement 24 · standardAP
2012-10-04Efficacy · Supplement 22 · standard — Letter ↗AP
2012-10-02Manufacturing (CMC) · Supplement 20 · standard — Label ↗AP
2011-02-08Labeling · Supplement 19 · unknown — Letter ↗AP
2010-02-19REMS · Supplement 18 — Letter ↗AP
2009-08-07Efficacy · Supplement 12 · unknown — Letter ↗AP
2009-08-07Labeling · Supplement 16 · standard — Label ↗AP
2009-03-17Labeling · Supplement 15 · standard — Label ↗AP
2009-02-13Labeling · Supplement 14 · standard — Letter ↗AP
2007-06-01Labeling · Supplement 11 · standard — Letter ↗AP
2007-02-15Efficacy · Supplement 10 · unknown — Letter ↗AP
2005-11-29Labeling · Supplement 7 · standard — Letter ↗AP
2005-11-29Efficacy · Supplement 6 · standard — Letter ↗AP
2004-11-24Labeling · Supplement 4 · standard — Letter ↗AP
2003-10-06Efficacy · Supplement 1 · standard — Review ↗AP
2001-11-20Type 1 - New Molecular Entity · Original · standard — REMS ↗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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