Details for New Drug Application (NDA): 212156

NDA 212156 describes MICAFUNGIN, which is a drug marketed by Endo Operations, Teva Pharms Usa Inc, Baxter Hlthcare Corp, Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms, and is included in eleven NDAs. It is available from one supplier. Additional details are available on the MICAFUNGIN profile page.

The generic ingredient in MICAFUNGIN 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 212156

Tradename:	MICAFUNGIN
Applicant:	Endo Operations
Ingredient:	micafungin sodium
Patents:	0

Pharmacology for NDA: 212156

Suppliers and Packaging for NDA: 212156

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICAFUNGIN	micafungin sodium	POWDER;INTRAVENOUS	212156	NDA	Endo USA, Inc.	42023-229	42023-229-10	10 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10) / 10 mL in 1 VIAL, SINGLE-DOSE
MICAFUNGIN	micafungin sodium	POWDER;INTRAVENOUS	212156	NDA	Endo USA, Inc.	42023-230	42023-230-10	10 VIAL, SINGLE-DOSE in 1 CARTON (42023-230-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Jun 16, 2021	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Jun 16, 2021	TE:		RLD:	Yes

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