Last Updated: June 23, 2026

Details for New Drug Application (NDA): 219518

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NDA 219518 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Aspiro, Biocon Pharma, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, Yichang Humanwell, and Zydus Pharms, and is included in twelve NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

Summary for 219518

Tradename:	MICAFUNGIN SODIUM
Applicant:	Yichang Humanwell
Ingredient:	micafungin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Feb 24, 2026	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Feb 24, 2026	TE:	AP	RLD:	No

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