APPLICATION
ANDA216506
TYPE
ANDA
ORIGINAL APPROVAL
2025-07-18
LATEST ACTION
2025-07-18
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
CASPOFUNGIN ACETATEPrescription
CASPOFUNGIN ACETATE 70MG/VIAL · POWDER · INTRAVENOUS
CASPOFUNGIN ACETATEPrescription
CASPOFUNGIN ACETATE 50MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-07-18UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.