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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 212125

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NDA 212125 describes MICAFUNGIN, which is a drug marketed by Ph Health, Teva Pharms Usa Inc, Baxter Hlthcare Corp, Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, and Zydus Pharms, and is included in thirteen NDAs. It is available from one supplier. 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 are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

Summary for 212125

Tradename:	MICAFUNGIN
Applicant:	Teva Pharms Usa Inc
Ingredient:	micafungin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Jul 30, 2021	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Jul 30, 2021	TE:		RLD:	Yes

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