Details for New Drug Application (NDA): 215381

NDA 215381 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 215381

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

Pharmacology for NDA: 215381

Suppliers and Packaging for NDA: 215381

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	215381	ANDA	Meitheal Pharmaceuticals Inc.	71288-028	71288-028-11	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)
MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	215381	ANDA	Meitheal Pharmaceuticals Inc.	71288-028	71288-028-12	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-12) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Sep 28, 2022	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Sep 28, 2022	TE:	AP	RLD:	No

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