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FDA NDA · NDA216142

MICAFUNGIN IN SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA216142
TYPE
NDA
ORIGINAL APPROVAL
2023-09-29
LATEST ACTION
2023-09-29
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MICAFUNGIN IN SODIUM CHLORIDE 0.9% · ReferencePrescription
MICAFUNGIN SODIUM EQ 150MG BASE/150ML (EQ 1MG BASE/ML) · SOLUTION · INTRAVENOUS
MICAFUNGIN IN SODIUM CHLORIDE 0.9% · ReferencePrescription
MICAFUNGIN SODIUM EQ 50MG BASE/50ML (EQ 1MG BASE/ML) · SOLUTION · INTRAVENOUS
MICAFUNGIN IN SODIUM CHLORIDE 0.9% · ReferencePrescription
MICAFUNGIN SODIUM EQ 100MG BASE/100ML (EQ 1MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-09-29Type 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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