Dockets Entered On September 4, 2003

Table of Contents

Docket #

Title

1980N-0295. 1           OTC drug review policy statement 1

1985V-0189. 1           Laser Light Show. 1

1998P-0151. 1           Introduction Of Downed Cattle Into The Food Supply. 1

2000V-0310. 1           Laser Light Show. 1

2002N-0277. 1           Bioterrorism; Establishment & Maintenance of Records. 1

2002P-0013. 1           Rescind GRAS Status for Aluminum-containing Food Additives. 1

2002P-0120. 1           Request the immediate ban of Meridia (sibutramine) 1

2003P-0321. 2           Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin. 2

2003P-0413. 2           Hyrocodone Bitartrate and Acetaminophen Tabl;et, USP 7.5 mg/300 mg combination drug product is suitable for submission as a ANDA   2

2003P-0414. 2           Hydrocondone Bitartrate and Acetaminophen tablets 5 mg/300 mg as an ANDA.. 2

2003V-0179. 2           Laser Light Show. 2

2003V-0354. 2           Laser light Show. 2

2003V-0359. 2           Laser Light Show. 2

2003V-0374. 2           Laser Light Show. 2

1980N-0295

OTC drug review policy statement

MM 129

FDA & Lil' Drug Store

Vol #:

3

1985V-0189

Laser Light Show

VRA 12

HFZ-300 to Todd Rogers dba Beamin Lasers

Vol #:

1

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

C 6979

Elisa Frey

Vol #:

296

C 6980

Jane Cranford

Vol #:

296

C 6981

Mr. Carson Cross

Vol #:

296

C 6982

Mr. Donald Tinkham

Vol #:

296

C 6983

Tracy Mc Burnette

Vol #:

296

C 6984

Mrs. Terese Blumette

Vol #:

296

C 6985

Diana Newago Knoke

Vol #:

296

C 6986

Leigh Harris CSW-R & Sherwin Harris M.D.

Vol #:

296

C 6987

Marilyn Sheller

Vol #:

296

C 6988

Michael Williams et al

Vol #:

296

C 6989

Terri Sides Azevedo

Vol #:

296

C 6990

Leslie J. Peterson

Vol #:

299

C 6991

Cindy Detwiler

Vol #:

299

C 6992

Ms. Gail A. Wilson

Vol #:

299

C 6993

Eva Hoerler

Vol #:

299

C 6994

Mitch Cataldo

Vol #:

299

C 6995

Lisa Kelly

Vol #:

299

C 6996

Charlene Sehorn & Family

Vol #:

299

C 6997

Denise Kuestner

Vol #:

299

C 6998

Kathleen Walden

Vol #:

299

C 6999

Jane Cranford

Vol #:

299

C 7000

Ms. Cara Tomson

Vol #:

299

C 7001

The National Humane Education Society

Vol #:

299

C 7002

Keitha A. McDonald

Vol #:

299

2000V-0310

Laser Light Show

VRA 2

HFZ-300 to Alexander Brest Planetarium, Museum of Science and History

Vol #:

1

2002N-0277

Bioterrorism; Establishment & Maintenance of Records

EMC 155

Suzanne

Vol #:

16

EMC 156

Ministry of Fisheries of the Socialist Republic of Vietnam

Vol #:

16

EMC 157

World Shipping Council

Vol #:

16

2002P-0013

Rescind GRAS Status for Aluminum-containing Food Additives

LET 5

HFS-265 to Food Analysis and Diagnostic Laboratory

Vol #:

1

2002P-0120

Request the immediate ban of Meridia (sibutramine)

SUP 1

Public Citizen

Vol #:

1

2003E-0407

Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146

APP 1

Wyeth

Vol #:

1

LET 1

U.S. Patent & Trademark Office

Vol #:

1

2003E-0410

Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868

APP 1

Johnson & Johnson

Vol #:

1

LET 1

U.S. Patent & Trademark Office

Vol #:

1

2003E-0411

Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262

APP 1

LG Life Sciences, Ltd.

Vol #:

1

LET 1

U.S. Patent & Trademark Office

Vol #:

1

2003E-0416

Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353

APP 1

Novartis Pharmaceuticals Corporation

Vol #:

1

LET 1

United States Patent and Trademark Office

Vol #:

1

2003E-0417

Frova (Frovatriptan Succinate), Patent Term Extension Application; U. S. Patent No. 5,616,603

APP 1

Vernalis Limited

Vol #:

1

LET 1

United States Patent and Trademark Office

Vol #:

1

2003M-0375

P020033 - INDEPENDENCE iBOT 3000 Mobility System, Approved 8/13/03

AAV 1

Independence Technology LLC

Vol #:

1

2003M-0381

P020036 - S.M.A.R.T. Nitinol Stent System and S.M.A.R.T. Control Nitinol Stent System

AAV 1

Cordis Corporation

Vol #:

1

2003P-0321

Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin

C 4

Three Rivers Pharmaceuticals LLC

Vol #:

2

C 5

Geneva Pharmaceuticals Inc

Vol #:

2

EMC 58

Rob Camp

Vol #:

2

EMC 59

Number not used

Vol #:

2

EMC 60

Carol Allison

Vol #:

2

EMC 61

Number not used

Vol #:

2

EMC 62

Anna Beaudette

Vol #:

2

EMC 63

Number not used

Vol #:

2

EMC 64

Joanne K Patterson

Vol #:

2

EMC 65

Russell S Patterson

Vol #:

2

EMC 66

Audbrey M Massler

Vol #:

2

EMC 67

Andrew Patterson

Vol #:

2

EMC 68

Catherine Hammell

Vol #:

2

EMC 69

Number not used

Vol #:

2

EMC 70

Number not used

Vol #:

2

EMC 71

A Alexander

Vol #:

2

EMC 72

Number not used

Vol #:

2

EMC 73

Mark Hammer

Vol #:

2

EMC 74

Anne Swasey

Vol #:

2

EMC 75

jva

Vol #:

2

EMC 76

R J Ledford

Vol #:

2

EMC 77

Joyce D Crist

Vol #:

2

EMC 78

Jeanette McCants

Vol #:

2

2003P-0413

Hyrocodone Bitartrate and Acetaminophen Tabl;et, USP 7.5 mg/300 mg combination drug product is suitable for submission as a ANDA

ACK 1

HFA-305 to Lachman Consultant Services, Inc.

Vol #:

1

ACK 2

number not used

Vol #:

1

CP 1       Attachment A, B, C, D

Lachman Consultant Services, Inc.

Vol #:

1

2003P-0414

Hydrocondone Bitartrate and Acetaminophen tablets 5 mg/300 mg as an ANDA

ACK 1

HFA-305 to Lachman Consultant Services, Inc.

Vol #:

1

CP 1         Attachment A, B, C, D

Lachman Consultant Services, Inc.

Vol #:

1

2003V-0179

Laser Light Show

VRA 1

HFZ-300 to Musititlan Entertainment

Vol #:

1

2003V-0354

Laser light Show

VRA 1

HFZ-300 to Cashiers Astronomical Observers, Inc

Vol #:

1

2003V-0359

Laser Light Show

VRA 1

HFZ-300 to OUO Entertainment Corporation

Vol #:

1

2003V-0374

Laser Light Show

VRA 1

HFZ-300 to Beaming Man

Vol #:

1