DOCKETS MANAGEMENT

Dockets Entered On July 16, 2003

Table of Contents (Linked)

Docket #

Title

1976N-0052G

OTC general comments & combinations

1994P-0036

Req labeling of trans fatty acid & prohibit deceptive claims

1995S-0117

Human Drugs Patent Term Extension & New Patents

1997P-0130

Require Percentage Ingredient Labeling

1999D-1738

Bioavilability & Bioequivalence Studies for Nasal Aerosols

2000P-1322

Food Labeling and Allergen Contamination Control

2002N-0496

Large & Small Volume Parenterals Used in Total Parenteral Nu

2003D-0118

Decorative Contact Lens (Import alert #86-10)

2003N-0169

Dental Amalgam; Request for Information

2003P-0315

Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug

Contents

1976N-0052G

OTC general comments & combinations

LET 121

Lil' Drug Store Products

Vol #:

35

1994P-0036

Req labeling of trans fatty acid & prohibit deceptive claims

MM 3

HFS-830 and Cargill Specialty Oils

Vol #:

84

1995S-0117

Human Drugs Patent Term Extension & New Patents

LST 85

List as of July 15, 2003

Vol #:

6

1997P-0130

Require Percentage Ingredient Labeling

ANS 1

DHHS/PHS/FDA/CFSAN

Vol #:

5

1999D-1738

Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 22

Generic Pharmaceutical Assn.

Vol #:

2

EMC 2

Image Therm Engineering, Inc.

Vol #:

2

1999P-1231

Revise Labeling on Tamoxifen (Nolvadex)

C 1

Edward Jaffe

Vol #:

1

2000P-1211

Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 5643

Daniel Clalyton

Vol #:

788

EMC 5644

Andrea Orzoff

Vol #:

788

EMC 5645

Andrea Orzoff

Vol #:

788

EMC 5646

Sonia Fletcher MT (ASCP)

Vol #:

788

2000P-1322

Food Labeling and Allergen Contamination Control

ANS 10

HFS-811 to Christine Spreitzer

Vol #:

30

ANS 11

HFS-811 to Marie Kawaguchi

Vol #:

30

C 532

Christine Spreitzer

Vol #:

30

C 533

Eric Friedman

Vol #:

30

C 534

John Corbett

Vol #:

30

C 535

Joseph Matthews

Vol #:

30

C 536

Marie Kawaguchi

Vol #:

30

2002N-0496

Large & Small Volume Parenterals Used in Total Parenteral Nu

SS 1

HFA-250

Vol #:

1

2003D-0118

Decorative Contact Lens (Import alert #86-10)

C 39

Sears Optical

Vol #:

1

C 40

Eyecare/Eyewear of Summerville

Vol #:

1

C 41

John W.L. Smith, O.D. & Angela M. Patterson, O.D.

Vol #:

1

C 42

Scott A. Kennedy, O.D.

Vol #:

1

C 43

Timothy C. Nichols, O.D., P.C., Family Eyecare

Vol #:

1

C 44

Moman's Eyecare

Vol #:

1

C 45

Dr. Richard T. Trask & Associates

Vol #:

1

C 46

Bailey Cove Eye Care, P.C.

Vol #:

1

2003N-0169

Dental Amalgam; Request for Information

C 11

Zach Calhoun

Vol #:

4

EMC 194

Bernard Windham

Vol #:

6

EMC 195

Bernard Windham

Vol #:

6

EMC 196

Bernard Windham

Vol #:

6

EMC 197

Bernard Windham

Vol #:

6

EMC 198

Bernard Windham

Vol #:

6

EMC 199

Sandra Duffy, J.D.

Vol #:

6

EMC 200

Bernard Windham

Vol #:

6

EMC 201

Bernard Windham

Vol #:

6

EMC 202

Bernard Windham

Vol #:

6

EMC 203

Bernard Windham

Vol #:

6

EMC 204

Bernard Windham

Vol #:

6

EMC 205

Bernard Windham

Vol #:

6

EMC 206

Bernard Windham

Vol #:

6

EMC 207

Bernard Windham

Vol #:

6

EMC 208

Bernard Windham

Vol #:

6

EMC 209

Bernard Windham

Vol #:

6

EMC 210

Bernard Windham

Vol #:

6

EMC 211

Bernard Windham

Vol #:

6

EMC 212

Sandra Duffy, J.D.

Vol #:

6

EMC 213

Joseph C. Cowart

Vol #:

6

EMC 214

Bernard Windham

Vol #:

6

EMC 215

Bernard Windham

Vol #:

6

EMC 216

John Marotta

Vol #:

6

SUP 9

University of Kentucky/Col of Arts & Sciences

Vol #:

4

2003P-0315

Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug

CR 1

CollaGenex Pharmaceuitcals, Inc.

Vol #:

1

2003V-0138

Laser Light Show

VRA 1

HFZ-300 to KDPS

Vol #:

1

2003V-0316

Laser Light Show

ACK 1

HFA-305 to Imagery Laser

Vol #:

1

VAR 1

Imagery Laser

Vol #:

1