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Queensland Health
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Harvard Business School
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Generated: April 23, 2018

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 four suppliers. 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 drug master file entries for this compound. Fifty-nine 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
Therapeutic Class:Antibacterials
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 PD-Rx Pharmaceuticals, Inc. 43063-113 N 43063-113-03
LEVAQUIN levofloxacin TABLET;ORAL 020634 NDA Janssen Pharmaceuticals, Inc. 50458-920 N 50458-920-50

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 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-003 Sep 8, 2000 ➤ 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:

Johnson and Johnson
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Federal Trade Commission
Covington
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Julphar
Mallinckrodt
Farmers Insurance
QuintilesIMS

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