Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on September 10, 2001

TABLE OF CONTENTS

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95S-0117 Human Drugs Patent Term Extension & New Patents *
01P-0394 ANADA generic equivalent of innovator product Heartgard 30 *
01P-0396 Request that FDA ban the production and sale of all ephedra *

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 65 List as of August 31, 2001 Vol#: 4

01M-0392 PMA Avanta Metacarpophalangeal (MCP) Joint Implant Finger Pr

AAV 1 Avanta Orthopaedics Inc Vol#: 1

01N-0073 Exemption From Premarket Notification Requirements; Class 1

NCR 1 Vol#: 1

01P-0394 ANADA generic equivalent of innovator product Heartgard 30

ACK 1 HFA-305 Vol#: 1

01P-0396 Request that FDA ban the production and sale of all ephedra

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citizen Vol#: 1