Dockets Entered On August 20, 2003

Table of Contents

Docket #

Title

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

1997S-0162. 1      30-Day Structure Function Claim Notification Letters Dietary. 1

1998F-0717. 2      Sucrose esters of fatty acids with an average degree. 2

1998P-0610. 2      Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC. 2

2003D-0025. 2      Mammography Quality Standards Act Final Regs. Modifications. 2

2003D-0347. 2      Small Entity Compliance Guide; b. 2

2003D-0349. 2      Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) 2

2003N-0143. 2      Continued Over-the-Counter Status of Ipecac Syrup. 2

2003N-0187. 2      Agency Information Collection Activities; Submission for OMB Review; Comment Request; Postmarket Surveillance of Medical Devices  2

2003N-0191. 2      Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices  2

2003N-0335. 2      Withdrawal of Approval of 80 New Drug Applications and 75 Abbreviated New Drug Applications  2

2003V-0373. 2      Laser Light Show. 2

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

C 63

Procter & Gamble

Vol #:

153

LET 43

Lonza Inc

Vol #:

149

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10533

Weider Nutrition International Inc.

Vol #:

80

LET 10534

Weider Nutrition International Inc.

Vol #:

80

LET 10535

Weider Nutrition International Inc.

Vol #:

80

LET 10536

Weider Nutrition International Inc.

Vol #:

80

LET 10537

Weider Nutrition International Inc.

Vol #:

80

LET 10538

Weider Nutrition International Inc.

Vol #:

80

LET 10539

Weider Nutrition International Inc.

Vol #:

80

LET 10540

Weider Nutrition International Inc.

Vol #:

80

LET 10541

Weider Nutrition International Inc.

Vol #:

80

LET 10542

Weider Nutrition International Inc.

Vol #:

80

LET 10543

Weider Nutrition International Inc.

Vol #:

80

LET 10544

Weider Nutrition International Inc.

Vol #:

80

LET 10545

Weider Nutrition International Inc.

Vol #:

80

LET 10546

Weider Nutrition International Inc.

Vol #:

80

LET 10547

Weider Nutrition International Inc.

Vol #:

80

LET 10548

Weider Nutrition International inc.

Vol #:

80

LET 10549

Weider Nutrition International Inc.

Vol #:

80

LET 10550

Weider Nutrition International Inc.

Vol #:

80

LET 10551

Weider Nutrition International Inc.

Vol #:

80

LET 10552

Weider Nutrition International Inc.

Vol #:

80

LET 10553

Weider Nutrition International Inc.

Vol #:

80

LET 10554

Weider Nutrition International Inc.

Vol #:

80

LET 10555

Weider Nutrition International Inc.

Vol #:

80

LET 10556

Weider Nutrition International Inc.

Vol #:

80

LET 10557

Weider Nutrition International Inc.

Vol #:

80

LET 10558

Weider Nutrition International Inc.

Vol #:

80

LET 10559

Weider Nutrition International Inc.

Vol #:

80

LET 10560

Weider Nutrition International Inc.

Vol #:

80

LET 10561

Weider Nutrition International Inc.

Vol #:

80

LET 10562

Weider Nutrition International Inc.

Vol #:

80

LET 10563

Weider Nutrition International Inc.

Vol #:

80

LET 10564

Weider Nutrition International Inc.

Vol #:

80

LET 10565

Weider Nutrition International Inc.

Vol #:

80

LET 10566

Weider Nutrition International Inc.

Vol #:

80

LET 10567

Weider Nutrition International Inc.

Vol #:

80

LET 10568

Weider Nutrition International Inc.

Vol #:

80

LET 10569

Weider Nutrition International Inc.

Vol #:

80

LET 10570

Weider Nutrition International Inc.

Vol #:

80

LET 10571

Weider Nutrition International Inc.

Vol #:

80

LET 10572

Weider Nutrition International Inc.

Vol #:

80

LET 10573

Weider Nutrition International Inc.

Vol #:

80

LET 10574

Weider Nutrition International Inc.

Vol #:

80

LET 10575

Weider Nutrition International Inc.

Vol #:

80

LET 10576

Weider Nutrition International Inc.

Vol #:

80

LET 10577

Weider Nutrition International Inc.

Vol #:

80

1998F-0717

Sucrose esters of fatty acids with an average degree

NFR 1

FDA

Vol #:

1

1998P-0610

Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

EMC 93

Institute for Health and Productivity Management

Vol #:

5

2003D-0025

Mammography Quality Standards Act Final Regs. Modifications

GDL 2

Background Material

Vol #:

1

NAD 2

FDA

Vol #:

1

2003D-0347

Small Entity Compliance Guide; b

GDL 1

Background Material

Vol #:

1

NAD 1

FDA

Vol #:

1

2003D-0349

Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

NAD 1

FDA

Vol #:

1

2003N-0143

Continued Over-the-Counter Status of Ipecac Syrup

EMC 6

Rocky Mountain Poison & Drug Center, U of CO

Vol #:

1

Attachment

2003N-0187

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Postmarket Surveillance of Medical Devices

N 2

FDA

Vol #:

1

2003N-0191

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices

NCR 2

FDA

Vol #:

1

2003N-0335

Withdrawal of Approval of 80 New Drug Applications and 75 Abbreviated New Drug Applications

NWL 1

FDA

Vol #:

1

2003V-0373

Laser Light Show

ACK 1

Eagle River Bowl LLC.

Vol #:

1