Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021632

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ERAXIS (ANIDULAFUNGIN)
50MG/VIAL
Marketing Status: Prescription

Active Ingredient: ANIDULAFUNGIN
Proprietary Name: ERAXIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 50MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021632
Product Number: 001
Approval Date: Feb 17, 2006
Applicant Holder Full Name: VICURON HOLDINGS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ERAXIS (ANIDULAFUNGIN)
100MG/VIAL
Marketing Status: Prescription

Active Ingredient: ANIDULAFUNGIN
Proprietary Name: ERAXIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021632
Product Number: 002
Approval Date: Nov 14, 2006
Applicant Holder Full Name: VICURON HOLDINGS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information