← FDA DRUG APPROVALS

FDA NDA · NDA022433

BRILINTA

ticagrelor

Sponsor: ASTRAZENECA

APPLICATION
NDA022433
TYPE
NDA
ORIGINAL APPROVAL
2011-07-20
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BRILINTA · ReferencePrescription
TICAGRELOR 60MG · TABLET · ORAL
BRILINTA · ReferencePrescription
TICAGRELOR 90MG · TABLET · ORAL

Approval history

2026-05-07Labeling · Supplement 39 · standard — Letter ↗AP
2024-11-04Labeling · Supplement 37 · standard — Label ↗AP
2024-03-22Efficacy · Supplement 35 · standard — Letter ↗AP
2022-05-09Efficacy · Supplement 34 · priority — Letter ↗AP
2021-08-10Labeling · Supplement 32 · standard — Letter ↗AP
2021-02-17Labeling · Supplement 31 · standard — Letter ↗AP
2020-11-05Efficacy · Supplement 29 · priority — Label ↗AP
2020-09-15Labeling · Supplement 30 · standard — Letter ↗AP
2020-05-28Efficacy · Supplement 28 · standard — Label ↗AP
2019-10-24Labeling · Supplement 25 · standard — Letter ↗AP
2019-04-03Efficacy · Supplement 23 · standard — Letter ↗AP
2018-03-09Labeling · Supplement 22 · standard — Label ↗AP
2016-09-23Labeling · Supplement 20 · standard — Letter ↗AP
2016-08-11Labeling · Supplement 19 · standard — Label ↗AP
2016-07-22Labeling · Supplement 18 · standard — Letter ↗AP
2015-09-21Labeling · Supplement 17 · standard — Letter ↗AP
2015-09-16Manufacturing (CMC) · Supplement 16 · standardAP
2015-09-03Efficacy · Supplement 15 · priority — Review ↗AP
2015-06-24Manufacturing (CMC) · Supplement 14 · standardAP
2015-03-26Labeling · Supplement 13 · standard — Letter ↗AP
2014-07-18Manufacturing (CMC) · Supplement 12 · standardAP
2014-03-07Manufacturing (CMC) · Supplement 11AP
2013-12-13Labeling · Supplement 10 · standard — Letter ↗AP
2013-10-30REMS · Supplement 9 — Letter ↗AP
2013-03-29Labeling · Supplement 8 · standard — Label ↗AP
2013-01-24Labeling · Supplement 6 · unknown — Letter ↗AP
2012-12-05Manufacturing (CMC) · Supplement 4 · standardAP
2012-11-09Manufacturing (CMC) · Supplement 5 · standardAP
2011-07-20Type 1 - New Molecular Entity · 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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