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FDA NDA · NDA210852

FRINDOVYX

cyclophosphamide

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA210852
TYPE
NDA
ORIGINAL APPROVAL
2023-06-07
LATEST ACTION
2025-08-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FRINDOVYX · ReferencePrescription
CYCLOPHOSPHAMIDE 2GM/4ML (500MG/ML) · SOLUTION · INTRAVENOUS
FRINDOVYX · ReferencePrescription
CYCLOPHOSPHAMIDE 500MG/ML (500MG/ML) · SOLUTION · INTRAVENOUS
FRINDOVYX · ReferencePrescription
CYCLOPHOSPHAMIDE 1GM/2ML (500MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-08-01Labeling · Supplement 6 · standard — Label ↗AP
2025-01-24Labeling · Supplement 5 · standard — Label ↗AP
2023-06-07Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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