Details for New Drug Application (NDA): 207344

NDA 207344 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms, and is included in seven 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 207344

Tradename:	MICAFUNGIN SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	micafungin sodium
Patents:	0

Pharmacology for NDA: 207344

Suppliers and Packaging for NDA: 207344

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344	ANDA	Fresenius Kabi USA, LLC	63323-728	63323-728-10	10 CARTON in 1 CARTON (63323-728-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-728-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344	ANDA	Fresenius Kabi USA, LLC	63323-729	63323-729-12	10 CARTON in 1 CARTON (63323-729-12) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	May 17, 2019	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	May 17, 2019	TE:	AP	RLD:	No

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