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Last Updated: May 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020634


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NDA 020634 describes LEVAQUIN, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the LEVAQUIN profile page.

The generic ingredient in LEVAQUIN is levofloxacin. There are thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 020634
Tradename:LEVAQUIN
Applicant:Janssen Pharms
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVAQUIN levofloxacin TABLET;ORAL 020634 NDA Janssen Pharmaceuticals, Inc. 50458-925 50458-925-50 50 TABLET, FILM COATED in 1 BOTTLE (50458-925-50)
LEVAQUIN levofloxacin TABLET;ORAL 020634 NDA Janssen Pharmaceuticals, Inc. 50458-930 50458-930-20 20 TABLET, FILM COATED in 1 BOTTLE (50458-930-20)
Paragraph IV (Patent) Challenges for 020634
Tradename Dosage Ingredient NDA Submissiondate
LEVAQUIN TABLET;ORAL levofloxacin 020634

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Dec 20, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Dec 20, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG
Approval Date:Sep 8, 2000TE:RLD:Yes

Expired US Patents for NDA 020634

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-003 Sep 8, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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