← FDA DRUG APPROVALS

FDA BLA · BLA761231

ALYMSYS

bevacizumab-maly

Sponsor: AMNEAL PHARMS LLC

APPLICATION
BLA761231
TYPE
BLA
ORIGINAL APPROVAL
2022-04-13
LATEST ACTION
2022-04-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ALYMSYSPrescription
BEVACIZUMAB-MALY 400MG/16ML(25MG/ML · INJECTABLE · INJECTION
ALYMSYSPrescription
BEVACIZUMAB-MALY 100MG/4ML(25MG/ML · INJECTABLE · INJECTION

Approval history

2022-04-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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