Details for New Drug Application (NDA): 213363

NDA 213363 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 213363

Tradename:	MICAFUNGIN SODIUM
Applicant:	Jiangsu Hansoh Pharm
Ingredient:	micafungin sodium
Patents:	0

Pharmacology for NDA: 213363

Suppliers and Packaging for NDA: 213363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213363	ANDA	Sagent Pharmaceuticals	25021-190	25021-190-10	1 VIAL in 1 CARTON (25021-190-10) / 5 mL in 1 VIAL
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213363	ANDA	Sagent Pharmaceuticals	25021-190	25021-190-11	10 VIAL in 1 CARTON (25021-190-11) / 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:	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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