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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
AstraZeneca
Cantor Fitzgerald
Fuji
Cipla
Julphar
Argus Health
Chubb
Federal Trade Commission

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020635

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NDA 020635 describes LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are twenty-nine drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 020635
Tradename:LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Janssen Pharms
Ingredient:levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Dec 20, 1996TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1996TE:RLD:Yes

Expired US Patents for NDA 020635

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
AstraZeneca
Chubb
Medtronic
QuintilesIMS
Julphar
Farmers Insurance
Fish and Richardson

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