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Generated: August 15, 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 thirty drug master file entries for this compound. Sixty-nine 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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Dec 20, 1996TE:RLD: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250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-003 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-003 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-005 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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