Dockets Entered On August 18, 2003

Table of Contents

Docket #

Title

1996N-0417. 1    CGMP in Mfg. Packing or Holding Dietary Supplements. 1

2003P-0372. 2    Refuse to approve any ANDA for doxycycline hyclate capsules 20mg. 2

2003V-0373. 2    Laser Light Show. 2

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 220

Arizona Nutritional Supplements Inc

Vol #:

38

C 221

Pharmanex LLD, Div of Nu Skin Enterprises Inc

Vol #:

38

C 222

Utah Natural Products Alliance

Vol #:

38

C 223

Pharmaceutical Printed Literature Association (PPLA)

Vol #:

38

C 224

Jagulana Herbal Products Inc

Vol #:

38

C 225

Mineral Resources International

Vol #:

39

C 226

Morinda Inc

Vol #:

39

C 227

Sean Seery MS LAc

Vol #:

39

C 228

Serron White

Vol #:

39

C 229

Cera Products, LLC

Vol #:

39

C 230

The Synergy Company of Utah LLC

Vol #:

39

C 231

Durk Pearson, Sandy Shaw

Vol #:

40

C 232

Med-Tox Group

Vol #:

39

C 233

GCI Nutrients

Vol #:

39

C 234

Consac Industries Inc dba COuntry Life

Vol #:

39

C 235

Congress of the United States

Vol #:

39

C 236

4Life Research

Vol #:

39

C 237

Cargill Health & Food Technologies

Vol #:

39

C 238

Desert Laboratories International

Vol #:

39

C 239

Your Vitamins Inc

Vol #:

39

EMC 112

Darko J Prce MSc CNP RNCP

Vol #:

35

EMC 113

Billie Powell

Vol #:

35

EMC 114

Yvonne Jacksony

Vol #:

46

EMC 115

K G Mitchell

Vol #:

35

EMC 116

Dr. Brenda Franey

Vol #:

35

EMC 117

Robert E Richards

Vol #:

35

EMC 118

W G Hiler

Vol #:

35

EMC 119

Bill Wolfe

Vol #:

35

EMC 120

Bill

Vol #:

35

EMC 121

Harriet Allen

Vol #:

35

EMC 122

Holly

Vol #:

35

EMC 123

Peter

Vol #:

35

EMC 124

Rick Hallas

Vol #:

35

EMC 125

John Suerth

Vol #:

35

EMC 126

Kent L Kistler

Vol #:

35

EMC 127

Christine Clark

Vol #:

35

EMC 128

Number not used

Vol #:

35

EMC 129

Standard Process Southeast, Inc.

Vol #:

35

EMC 130

Daniel C Rose

Vol #:

35

EMC 131

Michelle Hobbs

Vol #:

35

EMC 132

Art Davis

Vol #:

35

EMC 133

Kent L Kistler

Vol #:

35

EMC 134

Fishsur

Vol #:

35

EMC 135

Carol Selick

Vol #:

35

EMC 136

Deb Ley

Vol #:

35

EMC 137

Virginiad

Vol #:

35

EMC 138

Jill Buzan

Vol #:

35

EMC 139

Joseph Wong-Sing

Vol #:

35

EMC 140

Robert Patrick

Vol #:

35

EMC 141

Jws

Vol #:

35

EMC 142

Nadia Staniewska

Vol #:

35

EMC 143

Edmund R Hollis

Vol #:

35

EMC 144

David J Fonda

Vol #:

35

EMC 145

Richard Sugimoto

Vol #:

35

EMC 146

Stephen

Vol #:

35

EMC 147

Jack Dea

Vol #:

35

EMC 148

Dina Levine

Vol #:

35

EMC 149

Lauri Shook

Vol #:

35

EMC 150

Mary Cavanaugh

Vol #:

35

EMC 151

Ralph Torello, Charles Torello

Vol #:

35

EMC 152

Stuart Cardall

Vol #:

35

EMC 153

Lynda Benninger

Vol #:

35

EMC 154

James M Silver

Vol #:

35

EMC 155

Kerry

Vol #:

35

EMC 156

Maria Todd

Vol #:

35

EMC 157

Roberta Lewis

Vol #:

35

EMC 158

Sean Emery

Vol #:

35

EMC 159

Jeremy E Kaslow MD FACP FACAAI

Vol #:

35

EMC 160

Lynn Kowalski

Vol #:

35

EMC 161

David L McMasters

Vol #:

36

EMC 162

David L McMasters

Vol #:

36

EMC 163

Kimberly Barber

Vol #:

36

EMC 164

Angel Muehlenkamp

Vol #:

36

EMC 165

Peter Brackett

Vol #:

36

EMC 166

Ortho Molecular Products

Vol #:

36

EMC 167

Michael A Thomas

Vol #:

36

EMC 168

Charles G Smith PhD

Vol #:

36

EMC 169

Staci Howard

Vol #:

36

EMC 170

Felix Bronstein

Vol #:

36

EMC 171

David Malony

Vol #:

36

EMC 172

Della Pangborn

Vol #:

36

EMC 173

Carole Perez

Vol #:

36

EMC 174

Ortho Molecular Products

Vol #:

36

EMC 175

Jarita Sadler

Vol #:

36

EMC 176

Hon Barbara A Mikulski (CI)

Vol #:

36

EMC 177

Gregory McLean

Vol #:

36

EMC 178

Indena USA East, Inc

Vol #:

36

Attachment 1, 2, 3

EMC 179

BASF Corporation

Vol #:

36

EMC 180

Mercy Ule, LAc

Vol #:

36

EMC 181

Scott Buesing

Vol #:

36

EMC 182

P van Gelder

Vol #:

36

EMC 183

Napi Ippolito

Vol #:

36

EMC 184

Andrew Williams

Vol #:

36

EMC 185

Antoinette Katon

Vol #:

36

EMC 186

Bonnie Lewinstein

Vol #:

36

EMC 187

SupplementQuality.com

Vol #:

36

EMC 188

Donna J Dudley

Vol #:

36

EMC 189

Zhejiang Medicine Co., Ltd Xinchang Pharmaceutical Factory

Vol #:

36

EMC 190

Shivalik Natural Polymers

Vol #:

36

EMC 191

Andrew Williams

Vol #:

36

EMC 192

Consumer Healthcare Products Association (CHPA)

Vol #:

36

EMC 193

William F Popin

Vol #:

36

EMC 194

William F Popin

Vol #:

36

EMC 195

Robert Lane

Vol #:

36

EMC 196

Joanne Roberts, Amala Soumyanath, Pamela Martin-Buresh

Vol #:

36

EMC 197

GNC Live Well

Vol #:

36

EMC 198

NBTY Inc

Vol #:

36

EMC 199

Pharmavite LLC

Vol #:

36

EMC 200

Tyash

Vol #:

36

EMC 201

Tyash

Vol #:

36

EMC 202

American Herbalists Guild

Vol #:

36

EMC 203

Botanical Liaisons, LLC

Vol #:

36

EMC 204

Mieke Sala

Vol #:

36

EMC 205

Patricia Smith

Vol #:

36

EMC 206

Patricia Lee

Vol #:

36

EMC 207

Holt Boshart

Vol #:

36

EMC 208

Lori Smulling

Vol #:

36

EMC 209

Edith Messer

Vol #:

25

EMC 210

Janie Lambie

Vol #:

36

EMC 211

Arjuna Natural Extracts Ltd

Vol #:

36

EMC 212

Consumer Healthcare Products Association (CHPA)

Vol #:

36

EMC 213

Diverstech Co

Vol #:

36

EMC 214

D&E Pharmaceutical, Inc.

Vol #:

36

EMC 215

Council for Responsible Nutrition

Vol #:

37

Attachment 1, 2, 3, 4

EMC 216

Hon Chris Cannon

Vol #:

36

EMC 217

Magno-Humphries, Inc

Vol #:

36

EMC 218

Archon Vitamin Corporation

Vol #:

36

EMC 219

Banner Pharmacaps, Inc

Vol #:

36

EMC 220

4Life Research

Vol #:

36

EMC 221

Boehringer Ingleheim Consumer Healthcare

Vol #:

36

EMC 222

Daily manufacturing, Inc.

Vol #:

36

EMC 223

Nutrition NOW, Inc

Vol #:

36

Attachment

EMC 224

Charles K Thomas Company

Vol #:

36

EMC 225

Weider Nutrition Group, Inc.

Vol #:

36

Attachment

EMC 226

St Luke's Medical Center

Vol #:

36

EMC 227

Herbal Answers, Inc.

Vol #:

36

EMC 228

Herbalist & Alchemist, Inc

Vol #:

36

EMC 229

American Pharmacists Association

Vol #:

36

EMC 230

Cyanotech Corporation

Vol #:

36

EMC 231

Consac Industries, Inc. dba Country Life

Vol #:

36

EMC 232

Deseret Laboratories, International

Vol #:

36

EMC 233

Deseret Laboratories, International

Vol #:

36

EMC 234

Health Concerns, Inc

Vol #:

36

EMC 235

Zila Nutaceuticals, Inc.

Vol #:

38

EMC 236

American Botanical Council (ABC)

Vol #:

38

Attachment

EMC 237

Albion Advanced Nutrition

Vol #:

38

EMC 238

CSB Nutrition Corporation

Vol #:

38

EMC 239

Threshold Enterprises, Inc

Vol #:

38

EMC 240

Leslie Cerier

Vol #:

38

EMC 241

Herbalist & Alchemist, Inc

Vol #:

38

EMC 242

Nature's Life

Vol #:

38

EMC 243

Jost Chemical Co. Inc

Vol #:

38

EMC 244

Experimental and Applied Sciences, Inc. (EAS)

Vol #:

38

EMC 245

Vitality Works, Inc

Vol #:

38

EMC 246

Dawes

Vol #:

38

EMC 247

Dawes Part 2

Vol #:

38

SUP 1

AARP

Vol #:

38

Attachment

2003P-0372

Refuse to approve any ANDA for doxycycline hyclate capsules 20mg

ACK 1

HFA-305 to CollaGenex Pharmaceuticals

Vol #:

1

CP 1

CollaGenex Pharmaceuticals

Vol #:

1

Exhibit A, B

2003V-0373

Laser Light Show

VAR 1

Eagle River Bowl LLC.

Vol #:

1