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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020140

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FUSILEV (LEVOLEUCOVORIN CALCIUM)
EQ 50MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: LEVOLEUCOVORIN CALCIUM
Proprietary Name: FUSILEV
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020140
Product Number: 001
Approval Date: Mar 7, 2008
Applicant Holder Full Name: ACROTECH BIOPHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FUSILEV (LEVOLEUCOVORIN CALCIUM)
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVOLEUCOVORIN CALCIUM
Proprietary Name: FUSILEV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020140
Product Number: 002
Approval Date: Apr 29, 2011
Applicant Holder Full Name: ACROTECH BIOPHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
FUSILEV (LEVOLEUCOVORIN CALCIUM)
EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVOLEUCOVORIN CALCIUM
Proprietary Name: FUSILEV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020140
Product Number: 003
Approval Date: Apr 29, 2011
Applicant Holder Full Name: ACROTECH BIOPHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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