APPLICATION
ANDA211713
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-02
LATEST ACTION
2024-02-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MICAFUNGIN SODIUMPrescription
MICAFUNGIN SODIUM EQ 50MG BASE/VIAL · INJECTABLE · INTRAVENOUS
MICAFUNGIN SODIUMPrescription
MICAFUNGIN SODIUM EQ 100MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2024-02-29Manufacturing (CMC) · Supplement 2 · unknownAP
2021-06-02UNKNOWN · 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.