Last Updated: September 28, 2026

Details for New Drug Application (NDA): 212156

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NDA 212156 describes MICAFUNGIN, which is a drug marketed by Ph Health, Teva Pharms Usa Inc, Baxter Hlthcare Corp, 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 fifteen NDAs. There is one patent protecting this drug. Additional details are available on the MICAFUNGIN profile page.

The generic ingredient in MICAFUNGIN 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 212156

Tradename:	MICAFUNGIN
Applicant:	Ph Health
Ingredient:	micafungin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Jun 16, 2021	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Jun 16, 2021	TE:		RLD:	Yes

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