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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208366

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NDA 208366 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, and Zydus Pharms, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the MICAFUNGIN SODIUM profile page.

The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

Summary for 208366

Tradename:	MICAFUNGIN SODIUM
Applicant:	Apotex
Ingredient:	micafungin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Nov 5, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Nov 5, 2020	TE:		RLD:	No

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