Drug Approval Package

 Levaquin (Levofloxacin) Tablets & Injection
Company:  R.W. Johnson Pharmaceutical Research
Application No.:  020634/S008/S009 & 020635/S007/S008
Approval Date: 2/02/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

• Chemistry Review(s) (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: September 092004

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