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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 219273

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NDA 219273 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 219273

Tradename:	MICAFUNGIN SODIUM
Applicant:	Qilu Pharm Hainan
Ingredient:	micafungin sodium
Patents:	0

Pharmacology for NDA: 219273

Suppliers and Packaging for NDA: 219273

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	219273	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-771	68462-771-01	1 VIAL in 1 CARTON (68462-771-01) / 5 mL in 1 VIAL
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	219273	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-771	68462-771-10	10 VIAL in 1 CARTON (68462-771-10) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Apr 3, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Apr 3, 2025	TE:	AP	RLD:	No

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