Levaquin Tablets, Injection, and Oral Solution

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Brand NameLevaquin Tablets, Injection, and Oral Solution
Generic Namelevofloxacin
Marketed byOrtho-McNeil-Janssen Pharmaceuticals, Inc.
NDA/BLA HolderOrtho McNeil Janssen
NDA/BLA NumberNDA 20-634/ S-053, NDA 20-635/ S-058, NDA 21-721/ S-021
NDA/BLA Approval Date12/20/1996, 12/20/1996, 10/21/2004
StatusApproved
Review ClassificationStandard
REMS Approval Date4/27/2009
Class REMSFluoroquinolone Antibiotic
REMS Source Document
Boxed Warning?
Boxed Warning
Indication
Route of Administration
Mechanism of Action
Risks
Risks (MedGuide Language)
Approved Labeling
Medication Guide?
Medication Guide
Medication Guide Version
Communication Plan?
Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
Implementation System?
Implementation System
Assessment Program
Assessment Program Timeline
Branded Program
Program Description
Link to Branded Program
Deemed/Approved
Approval Letters

Sources

REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

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