Details for New Drug Application (NDA): 213261

NDA 213261 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms, and is included in eight 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 213261

Tradename:	MICAFUNGIN SODIUM
Applicant:	Hikma
Ingredient:	micafungin sodium
Patents:	0

Pharmacology for NDA: 213261

Suppliers and Packaging for NDA: 213261

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213261	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9361	0143-9361-01	1 VIAL in 1 CARTON (0143-9361-01) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213261	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9362	0143-9362-01	1 VIAL in 1 CARTON (0143-9362-01) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Jul 9, 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:	Jul 9, 2021	TE:	AP	RLD:	No

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