APPLICATION
BLA761399
TYPE
BLA
ORIGINAL APPROVAL
2025-03-07
LATEST ACTION
2025-12-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OMLYCLOPrescription
OMALIZUMAB-IGEC 300MG/2ML · INJECTABLE · INJECTION
OMLYCLOPrescription
OMALIZUMAB-IGEC 75MG/0.5ML · INJECTABLE · INJECTION
OMLYCLOPrescription
OMALIZUMAB-IGEC 150MG/ML · INJECTABLE · INJECTION
Approval history
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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