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FDA NDA · NDA208065

TAGRISSO

osimertinib

Sponsor: ASTRAZENECA

APPLICATION
NDA208065
TYPE
NDA
ORIGINAL APPROVAL
2015-11-13
LATEST ACTION
2024-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TAGRISSO · ReferencePrescription
OSIMERTINIB MESYLATE EQ 40MG BASE · TABLET · ORAL
TAGRISSO · ReferencePrescription
OSIMERTINIB MESYLATE EQ 80MG BASE · TABLET · ORAL

Approval history

2024-09-25Efficacy · Supplement 33 · priority — Letter ↗AP
2024-04-29Labeling · Supplement 31 · standard — Letter ↗AP
2024-02-16Efficacy · Supplement 30 · priority — Label ↗AP
2024-01-31Efficacy · Supplement 29 · standard — Letter ↗AP
2023-06-21Labeling · Supplement 28 · standard — Letter ↗AP
2022-10-21Labeling · Supplement 27 · standard — Letter ↗AP
2022-09-30Labeling · Supplement 26 · standard — Letter ↗AP
2022-01-19Labeling · Supplement 25 · standard — Letter ↗AP
2021-07-26Labeling · Supplement 22 · standard — Label ↗AP
2020-12-18Efficacy · Supplement 21 · priority — Label ↗AP
2020-12-11Labeling · Supplement 19 · standard — Label ↗AP
2020-12-09Efficacy · Supplement 18 · standard — Label ↗AP
2020-05-23Efficacy · Supplement 16 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 13 · standard — Letter ↗AP
2018-08-28Labeling · Supplement 11 · standard — Label ↗AP
2018-04-18Efficacy · Supplement 8 · priority — Label ↗AP
2018-04-18Labeling · Supplement 9 · standard — Letter ↗AP
2017-10-31Labeling · Supplement 7 · standard — Label ↗AP
2017-03-30Efficacy · Supplement 6 · priority — Label ↗AP
2016-09-28Labeling · Supplement 3 · standard — Letter ↗AP
2016-08-12Labeling · Supplement 2 · standard — Label ↗AP
2016-02-10Manufacturing (CMC) · Supplement 1 · priorityAP
2015-11-13Type 1 - New Molecular Entity · Original · priority — Summary Review ↗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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