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FDA BLA · BLA761034

TECENTRIQ

atezolizumab

Sponsor: GENENTECH INC

APPLICATION
BLA761034
TYPE
BLA
ORIGINAL APPROVAL
2016-05-18
LATEST ACTION
2026-05-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TECENTRIQPrescription
ATEZOLIZUMAB 1200MG/20ML · INJECTABLE · INJECTION

Approval history

2026-05-15Efficacy · Supplement 61 · priority — Letter ↗AP
2026-05-12Labeling · Supplement 62 · standard — Letter ↗AP
2025-11-17Labeling · Supplement 59 · standard — Label ↗AP
2025-10-02Efficacy · Supplement 58 · priority — Label ↗AP
2025-08-18Labeling · Supplement 57 · standard — Letter ↗AP
2024-04-22Labeling · Supplement 53 · standard — Letter ↗AP
2023-05-12Labeling · Supplement 49 · standard — Letter ↗AP
2023-05-12Labeling · Supplement 51 · standard — Letter ↗AP
2022-12-09Efficacy · Supplement 47 · priority — Label ↗AP
2022-12-02Efficacy · Supplement 50 · priority — Label ↗AP
2022-01-21Labeling · Supplement 43 · standard — Letter ↗AP
2021-10-15Efficacy · Supplement 42 · priority — Letter ↗AP
2021-10-06Efficacy · Supplement 44 · standard — Letter ↗AP
2021-04-13Efficacy · Supplement 41 · priority — Letter ↗AP
2021-02-17Efficacy · Supplement 38 · priority — Label ↗AP
2021-02-17Efficacy · Supplement 36 · priority — Label ↗AP
2021-02-17Efficacy · Supplement 34 · priority — Label ↗AP
2021-02-17Efficacy · Supplement 37 · priority — Label ↗AP
2021-02-17Efficacy · Supplement 35 · priority — Label ↗AP
2021-02-17Efficacy · Supplement 33 · priority — Label ↗AP
2020-12-18Efficacy · Supplement 32 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 31 · standard — Letter ↗AP
2020-11-10Labeling · Supplement 20 · standard — Letter ↗AP
2020-09-30Efficacy · Supplement 29 · priority — Letter ↗AP
2020-07-30Efficacy · Supplement 28 · priority — Label ↗AP
2020-05-29Efficacy · Supplement 25 · priority — Label ↗AP
2020-05-18Efficacy · Supplement 27 · priority — Label ↗AP
2019-12-03Efficacy · Supplement 21 · standard — Label ↗AP
2019-05-06Efficacy · Supplement 13 · standard — Label ↗AP
2019-05-06Efficacy · Supplement 14 · standard — Label ↗AP
2019-03-18Efficacy · Supplement 19 · priority — Label ↗AP
2019-03-08Efficacy · Supplement 18 · priority — Label ↗AP
2018-12-06Efficacy · Supplement 9 · priority — Label ↗AP
2018-07-02Efficacy · Supplement 12 · priority — Label ↗AP
2018-06-26Labeling · Supplement 11 · standard — Label ↗AP
2018-06-19Efficacy · Supplement 10 · priority — Label ↗AP
2018-06-14Efficacy · Supplement 8 · priority — Letter ↗AP
2018-04-30Efficacy · Supplement 3 · standard — Letter ↗AP
2018-03-13Labeling · Supplement 5 · standard — Label ↗AP
2017-04-17Efficacy · Supplement 1 · 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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