Drug Approval Package

Lotemax (Loteprednol) Etabonate Ophthalmic Suspension)
Company:  Bausch & Lomb
Application No.:  20-841
Approval Date: 3/9/1998

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)

Date created: April 04, 2002

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