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FDA NDA · NDA212156

MICAFUNGIN

Sponsor: PH HEALTH

APPLICATION
NDA212156
TYPE
NDA
ORIGINAL APPROVAL
2021-06-16
LATEST ACTION
2021-06-16
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2021-06-16Type 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.

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