Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211713

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NDA 211713 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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

Summary for 211713

Tradename:	MICAFUNGIN SODIUM
Applicant:	Xellia Pharms Aps
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:	Jun 2, 2021	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Jun 2, 2021	TE:	AP	RLD:	No

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