Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 020140

Expand all

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EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English