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Dockets Management

                       
 

Dockets Entered On September 3, 2003

Table of Contents

 
   
   
 
 

Docket #

 

Title

 
     

1975N-0183H. 1        Health-Care Antiseptic Drug Products for OTC Human Use. 1

2003E-0406. 1           Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804. 1

2003P-0408. 2           Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets  2

2003P-0409. 2           Reclassification Moblie Bearing Knees from class III and class II 2

2003Q-0401. 2          Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronary Heart Disease Health Claim  2

 

 

1975N-0183H

 

Health-Care Antiseptic Drug Products for OTC Human Use

 
 

C 79

 

Soap and Detergent Assn (SDA) & The Cosmetic, Toiletry, and Fragrance Assn (CTFA)

 

Vol #:

 

149

 
 
 

C 80           Appendix 1, bibliography,

references

 

Soap and Detergent Assn (SDA) & The Cosmetic, Toiletry, and Fragrance Assn (CTFA)

 

Vol #:

 

160

 
 
 

C 81                  Table of contents

 

Steris Corporation

 

Vol #:

 

161

 
 
 

C 82

Table of contents

 

Dial Corporation

 

Vol #:

 

162

 
 
 

C 83      Appendices

 

Colgate-Palmolive Company

 

Vol #:

 

164

 
 
 

C 84                     List of References, References

 

Soap and Detergent Assn (SDA) & Cosmetic, Toiletry, and Fragrance Assn (CTFA)

 

Vol #:

 

167

 
 
 

C 85     Attachments

 

Ciba Specialty Chemicals Corporation (Ciba)

 

Vol #:

 

170

 
 
 

2001P-0230

 

Domestic Marketing & Importation of Transgenic Fish

 
 
 

EMC 3046

 

Noelle Conti

 

Vol #:

 

252

 
 
 

EMC 3047

 

Alex Hurst

 

Vol #:

 

252

 
 
 

EMC 3048

 

Billie Campbell

 

Vol #:

 

252

 
 
 

EMC 3049

 

Scott Rogers

 

Vol #:

 

252

 
 
 

EMC 3050

 

Ms. Lee

 

Vol #:

 

252

 
 
 

EMC 3051

 

Anthony Vazquez

 

Vol #:

 

252

 
 
 

EMC 3052

 

Edna Jones

 

Vol #:

 

252

 
 
 

EMC 3053

 

Donna Plaisted

 

Vol #:

 

252

 
 
 

EMC 3054

 

Melina Yanez

 

Vol #:

 

252

 
 
 

EMC 3055

 

Evan Albright

 

Vol #:

 

252

 
 
 

EMC 3056

 

number not used

 

Vol #:

 

252

 
 
 

EMC 3057

 

Joan Jones

 

Vol #:

 

252

 
 
 

EMC 3058

 

William McMullin

 

Vol #:

 

252

 
 
 

EMC 3059

 

Tristano Brown

 

Vol #:

 

252

 
 
 

EMC 3060

 

Tahoe Foster

 

Vol #:

 

252

 
 
 

EMC 3061

 

Steve Celvin

 

Vol #:

 

252

 
 
 

EMC 3062

 

Faith Ann Robinson

 

Vol #:

 

252

 
 
 

EMC 3063

 

Mary Pat Dempsey-Frank

 

Vol #:

 

252

 
 
 

EMC 3064

 

David Gunnells

 

Vol #:

 

252

 
 
 

EMC 3065

 

Eileen Stark

 

Vol #:

 

252

 
                   
 

EMC 3066

 

Lynne Royall

 

Vol #:

 

252

 
 
 

EMC 3067

 

Amy Clapp

 

Vol #:

 

252

 
 
 

EMC 3068

 

Eileen Stark

 

Vol #:

 

252

 
 
 

EMC 3069

 

Kesha Ram

 

Vol #:

 

252

 
 
 

EMC 3070

 

Sandra Steidl

 

Vol #:

 

252

 
 
 

EMC 3071

 

Karen J. Angus

 

Vol #:

 

252

 
 
 

EMC 3072

 

Linda Bescript

 

Vol #:

 

252

 
 
 

EMC 3073

 

Judy Desreuisseau

 

Vol #:

 

252

 
 
 

EMC 3074

 

Glen Zorn

 

Vol #:

 

252

 
 
 

EMC 3075

 

Craig Marshall

 

Vol #:

 

252

 
 
 

EMC 3076

 

Jesse Gore

 

Vol #:

 

252

 
 
 

EMC 3077

 

Jan Grauman Neander

 

Vol #:

 

252

 
 
 

EMC 3078

 

Nancy Berman

 

Vol #:

 

252

 
 
 

EMC 3079

 

Kate Davis

 

Vol #:

 

252

 
 
 

EMC 3080

 

number not used

 

Vol #:

 

252

 
 
 

EMC 3081

 

Katy Dimmock

 

Vol #:

 

252

 
 
 

EMC 3082

 

Elizabeth Dodd

 

Vol #:

 

252

 
 
 

EMC 3083

 

Etoile Pinder

 

Vol #:

 

252

 
 
 

EMC 3084

 

Jennifer Humowiecki

 

Vol #:

 

252

 
 
 

EMC 3085

 

Bill & Jan Tache

 

Vol #:

 

252

 
 
 

EMC 3086

 

Sarah Roberts

 

Vol #:

 

252

 
 
 

EMC 3087

 

Ray Apodacaq

 

Vol #:

 

252

 
 
 

EMC 3088

 

Molly Jacques

 

Vol #:

 

252

 
 
 

EMC 3089

 

Barbara Markham

 

Vol #:

 

252

 
 
 

EMC 3090

 

Jodi Ecel Cifrese

 

Vol #:

 

252

 
 
 

EMC 3091

 

Kerisha Crutcher

 

Vol #:

 

252

 
 
 

EMC 3092

 

Raymond Wager

 

Vol #:

 

252

 
 

 

2003E-0406

 

Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804

 
 
 

APP 1                  Tab A, B, C, D, E, F

 

Genzyme Corporation

 

Vol #:

 

1

 
 
 

LET 1

 

U.S. Patent & Trademark Office

 

Vol #:

 

1

 
 

 

2003P-0408

 

Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets

 
 
 

ACK 1

 

HFA-305 to Lord, Bissell & Brook LLP

 

Vol #:

 

1

 
 
 

CP 1                     Tab A, B, C, D, E, F, G, H, I, J

 

TorPharm, Inc.

 

Vol #:

 

1

 
 

 

2003P-0409

 

Reclassification Moblie Bearing Knees from class III and class II

 
 
 

CCP 1

Table of contents

 

Orthopedic Surgical Manufacturers Assn.

 

Vol #:

 

1

 
                   

 

2003Q-0401

 

Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronary Heart Disease Health Claim

 
 
 

ACK 1

 

HFS-830 to Emord & Associates, PC

 

Vol #:

 

2

 
 
 

LET 1

 

Wellness Lifestyles Inc dba American Longevity and Life Extension Foundation Buyers Club

 

Vol #:

 

2

 
 
 

QHC 1

 

Wellness Lifestyles, Inc dba American Longevity & Life Extension Foundation Buyers Club Inc

 

Vol #:

 

1

 

Page Posted September 4, 2003 dp
Page updated September 30, 2003 jb

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