← FDA DRUG APPROVALS

FDA NDA · NDA022081

LETAIRIS

ambrisentan

Sponsor: GILEAD

APPLICATION
NDA022081
TYPE
NDA
ORIGINAL APPROVAL
2007-06-15
LATEST ACTION
2025-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LETAIRIS · ReferencePrescription
AMBRISENTAN 5MG · TABLET · ORAL
LETAIRIS · ReferencePrescription
AMBRISENTAN 10MG · TABLET · ORAL

Approval history

2025-04-04REMS · Supplement 45 — Label ↗AP
2024-08-19REMS · Supplement 44 — Letter ↗AP
2021-06-08REMS · Supplement 43 — Letter ↗AP
2020-12-22REMS · Supplement 42 — Letter ↗AP
2019-08-23Labeling · Supplement 41 · standard — Label ↗AP
2019-03-28REMS · Supplement 39 — Letter ↗AP
2018-11-30Labeling · Supplement 40 · standard — Label ↗AP
2017-09-27REMS · Supplement 38 — Letter ↗AP
2017-07-21REMS · Supplement 37 — Letter ↗AP
2016-12-15REMS · Supplement 36 — Letter ↗AP
2016-03-21Manufacturing (CMC) · Supplement 35 · priorityAP
2015-10-02Efficacy · Supplement 33 · standard — Letter ↗AP
2015-09-25Manufacturing (CMC) · Supplement 34 · priorityAP
2014-10-29REMS · Supplement 32 — Letter ↗AP
2014-09-26Manufacturing (CMC) · Supplement 28 · priorityAP
2014-07-02Manufacturing (CMC) · Supplement 26 · priorityAP
2014-05-05Labeling · Supplement 29 · standard — Letter ↗AP
2014-01-31REMS · Supplement 30 — Letter ↗AP
2013-08-17REMS · Supplement 19 — Label ↗AP
2013-01-16Manufacturing (CMC) · Supplement 24 · priorityAP
2013-01-10Manufacturing (CMC) · Supplement 23 · priorityAP
2012-10-19Labeling · Supplement 22 · unknown — Label ↗AP
2012-02-15Efficacy · Supplement 14 · standard — Letter ↗AP
2011-07-19Labeling · Supplement 18 · unknown — Label ↗AP
2011-03-03Labeling · Supplement 17 · unknown — Label ↗AP
2010-10-13Labeling · Supplement 12 · unknown — Label ↗AP
2010-08-24REMS · Supplement 16 — Letter ↗AP
2009-08-05Labeling · Supplement 10 · standard — Label ↗AP
2009-07-01Labeling · Supplement 11 · standard — Label ↗AP
2009-05-29Labeling · Supplement 8 · standard — Label ↗AP
2008-10-08Labeling · Supplement 4 · standard — Label ↗AP
2008-02-14Labeling · Supplement 2 · standard — Label ↗AP
2007-11-29Labeling · Supplement 1 · standard — Letter ↗AP
2007-06-15Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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