← FDA DRUG APPROVALS

FDA NDA · NDA212125

MICAFUNGIN

Sponsor: TEVA PHARMS USA INC

APPLICATION
NDA212125
TYPE
NDA
ORIGINAL APPROVAL
2021-07-30
LATEST ACTION
2021-07-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

MICAFUNGIN · ReferenceDiscontinued
MICAFUNGIN SODIUM EQ 50MG BASE/VIAL · POWDER · INTRAVENOUS
MICAFUNGIN · ReferenceDiscontinued
MICAFUNGIN SODIUM EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2021-07-30Type 5 - New Formulation or New Manufacturer · 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.

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 →