FDA BLA · BLA761452

IMMGOLIS

Sponsor: ACCORD BIOPHARMA INC.

APPLICATION

BLA761452

TYPE

BLA

ORIGINAL APPROVAL

2026-05-15

LATEST ACTION

2026-05-15

ROUTE

SOLUTION

DOSAGE FORM

INJECTION

MARKETING STATUS

Prescription

Products

IMMGOLISPrescription

GOLIMUMAB-SLDI 100MG/1ML · INJECTION · SOLUTION

IMMGOLIS INTRIPrescription

GOLIMUMAB-SLDI 50MG/4ML · INJECTION · SOLUTION

IMMGOLISPrescription

GOLIMUMAB-SLDI 50MG/0.5ML · INJECTION · SOLUTION

2026-05-15Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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