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FDA NDA · NDA217171

SYFOVRE

pegcetacoplan

Sponsor: APELLIS PHARMS

APPLICATION
NDA217171
TYPE
NDA
ORIGINAL APPROVAL
2023-02-17
LATEST ACTION
2025-03-27
ROUTE
INTRAVITREAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SYFOVRE · ReferencePrescription
PEGCETACOPLAN 15MG/0.1ML (15MG/0.1ML) · SOLUTION · INTRAVITREAL

Approval history

2025-03-27Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2024-12-20Labeling · Supplement 2 · standard — Label ↗AP
2023-11-30Labeling · Supplement 1 · standard — Label ↗AP
2023-02-17Type 3 - New Dosage Form · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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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