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Last Updated: January 17, 2021

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Details for New Drug Application (NDA): 020140

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NDA 020140 describes FUSILEV, which is a drug marketed by Acrotech and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the FUSILEV profile page.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 020140
Tradename:FUSILEV
Applicant:Acrotech
Ingredient:levoleucovorin calcium
Patents:1
Medical Subject Heading (MeSH) Categories for 020140
Paragraph IV (Patent) Challenges for 020140
Tradename Dosage Ingredient NDA Submissiondate
FUSILEV SOLUTION;INTRAVENOUS levoleucovorin calcium 020140 2013-12-19
FUSILEV POWDER;INTRAVENOUS levoleucovorin calcium 020140 2013-12-19
FUSILEV POWDER;INTRAVENOUS levoleucovorin calcium 020140 2011-10-26
FUSILEV SOLUTION;INTRAVENOUS levoleucovorin calcium 020140 2011-10-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Mar 7, 2008TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 7, 2022Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 29, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 7, 2022Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 29, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 7, 2022Product Flag?YSubstance Flag?YDelist Request?

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