Drug Approval Package

Amoxil (Amoxicillin) Capsules, Chewable Tablets, & Oral Powder
Company:  Smith Kline Beecham
Application No.:  50-542/S-005, S-010, S-011
Approval Date: 2/27/1998

• Approval Letter, Printed Labeling & Medical Review(s) (PDF) (1.1 MB)

• Microbiology Review(s) & Administrative Document(s)/Correspondence (PDF) (2.2 MB)

Date created: March 30, 2001; last update: July 1, 2005

Back to Top    Drugs@FDA

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