← FDA DRUG APPROVALS

FDA NDA · NDA220200

AVOPEF

etoposide

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA220200
TYPE
NDA
ORIGINAL APPROVAL
2026-02-13
LATEST ACTION
2026-02-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AVOPEF · ReferencePrescription
ETOPOSIDE 100MG/5ML (20MG/ML) · SOLUTION · INTRAVENOUS
AVOPEF · ReferencePrescription
ETOPOSIDE 500MG/25ML (20MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-02-13Type 3 - New Dosage Form · Original · standard — 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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