Drug Approval Package

 Prozac (Fluoxetine Hydrochloride) Pulvules & Solution Tablets
Company:  Lilly Research Laboratories
Application No.:  018936S052 & 020101S024
Approval Date: 10/07/1999

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)    

• Administrative Document(s) & Correspondence (PDF)

Date created: August 4, 2004

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.