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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020140

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NDA 020140 describes FUSILEV, which is a drug marketed by Spectrum Pharms and is included in one NDA. It is available from one supplier. 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. Six suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for NDA: 020140

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1

Suppliers and Packaging for NDA: 020140

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUSILEV
levoleucovorin calcium
 POWDER;IV (INFUSION) 020140 NDA Spectrum Pharmaceuticals, Inc. 68152-101 68152-101-00 1 VIAL in 1 CARTON (68152-101-00) > 5 mL in 1 VIAL
FUSILEV
levoleucovorin calcium
 SOLUTION;IV (INFUSION) 020140 NDA Spectrum Pharmaceuticals, Inc. 68152-101 68152-101-00 1 VIAL in 1 CARTON (68152-101-00) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 7, 2008TE:APRLD:Yes
Patent:6,500,829Patent Expiration:Mar 7, 2022Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Apr 29, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;IV (INFUSION)StrengthEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:6,500,829Patent Expiration:Mar 7, 2022Product Flag?YSubstance Flag?YDelist Request?


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Serving 500+ biopharmaceutical companies globally:

Teva
Healthtrust
Federal Trade Commission
Argus Health
Fuji
Baxter
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Covington
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McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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