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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021632

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NDA 021632 describes ERAXIS, which is a drug marketed by Vicuron Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the ERAXIS profile page.

The generic ingredient in ERAXIS is anidulafungin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.

Summary for 021632

Tradename:	ERAXIS
Applicant:	Vicuron Holdings
Ingredient:	anidulafungin
Patents:	0

Pharmacology for NDA: 021632

Suppliers and Packaging for NDA: 021632

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-0114	0049-0114-28	15 mL in 1 VIAL, SINGLE-USE (0049-0114-28)
ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-0116	0049-0116-28	30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Feb 17, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Nov 14, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021632

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006	⤷ Try a Trial	⤷ Try a Trial
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006	⤷ Try a Trial	⤷ Try a Trial
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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