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Details for New Drug Application (NDA): 021632

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

The generic ingredient in ERAXIS is anidulafungin. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.

Summary for NDA: 021632

Tradename:
ERAXIS
Applicant:
Vicuron
Ingredient:
anidulafungin
Patents:3
Therapeutic Class:Antifungals

Pharmacology for NDA: 021632

Ingredient-typeLipopeptides

Suppliers and Packaging for NDA: 021632

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Feb 17, 2006TE:RLD:Yes
Patent:5,965,525Patent Expiration:Feb 17, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS
Patent:6,960,564Patent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS
Patent:7,709,444Patent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS

Expired Orange Book Patents for NDA: 021632

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vicuron
ERAXIS
anidulafungin
INJECTABLE;IV (INFUSION)021632-001Feb 17, 20066,384,013► subscribe
Vicuron
ERAXIS
anidulafungin
INJECTABLE;IV (INFUSION)021632-002Nov 14, 20066,384,013► subscribe
Vicuron
ERAXIS
anidulafungin
INJECTABLE;IV (INFUSION)021632-002Nov 14, 20066,743,777► subscribe
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