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FDA BLA · BLA761028

MVASI

bevacizumab-awwb

Sponsor: AMGEN INC

APPLICATION
BLA761028
TYPE
BLA
ORIGINAL APPROVAL
2017-09-14
LATEST ACTION
2023-02-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MVASIPrescription
BEVACIZUMAB-AWWB 400MG/16ML (25MG/ML) · INJECTABLE · INJECTION
MVASIPrescription
BEVACIZUMAB-AWWB 100MG/4ML (25MG/ML) · INJECTABLE · INJECTION

Approval history

2023-02-17Bioequivalence · Supplement 11 · standard — Label ↗AP
2021-11-15Efficacy · Supplement 8 · standard — Letter ↗AP
2021-04-19Labeling · Supplement 6 · standard — Label ↗AP
2019-06-24Efficacy · Supplement 4 · standard — Letter ↗AP
2017-09-14Type 5 - New Formulation or New Manufacturer · 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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