← FDA DRUG APPROVALS

FDA NDA · NDA021632

ERAXIS

anidulafungin

Sponsor: VICURON HOLDINGS

APPLICATION
NDA021632
TYPE
NDA
ORIGINAL APPROVAL
2006-02-17
LATEST ACTION
2020-10-05
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ERAXIS · ReferencePrescription
ANIDULAFUNGIN 50MG/VIAL · POWDER · INTRAVENOUS
ERAXIS · ReferencePrescription
ANIDULAFUNGIN 100MG/VIAL · POWDER · INTRAVENOUS

Approval history

2020-10-05Labeling · Supplement 30 · standard — Letter ↗AP
2020-09-22Labeling · Supplement 29 · standard — Letter ↗AP
2020-09-22Efficacy · Supplement 27 · standard — Letter ↗AP
2018-01-05Labeling · Supplement 26 · standard — Letter ↗AP
2017-08-17Labeling · Supplement 24 · standard — Label ↗AP
2015-12-02Manufacturing (CMC) · Supplement 21 · standardAP
2014-06-09Manufacturing (CMC) · Supplement 20 · standardAP
2014-03-28Manufacturing (CMC) · Supplement 19 · standardAP
2012-07-20Labeling · Supplement 11 · standard — Label ↗AP
2010-11-04Labeling · Supplement 13 · unknown — Letter ↗AP
2009-06-05Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
2007-11-09Labeling · Supplement 6 · standard — Label ↗AP
2007-02-02Labeling · Supplement 4 · standard — Letter ↗AP
2006-11-15Manufacturing (CMC) · Supplement 3 — Label ↗AP
2006-08-07Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2006-02-17Type 1 - New Molecular Entity · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →