Dockets Entered On August 11, 2003

Table of Contents

Docket #

Title

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

1995N-0071. 1     Proposal to Debar Amirul Islam; Notice of Opportunity for He. 1

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

1998N-0359. 2     Program priorities/Center for Food Safety & Applied Nutrition. 2

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

2000N-1484. 2     Safety Reporting Requirements Human Drug/Biological Products. 2

2000P-1370. 2     ANDA for generic verions of Zaroxolyn Tablets (metolazone. 2

2002N-0534. 2     Medical Device User Fee and Modernization Act of 2002. 2

2003D-0165. 2     Current Good Manufacturing Practices for Medical Gases. 2

2003N-0344. 2     Consumer-Directed Promotion; Public Meeting. 2

2003P-0358. 2     Methenex (Methadone Hydrochloride 40 mg,Naloxone Hydrochloride 2 mg) tablets (effervescent) NDA 17-491/NDA 17-490 withdrawn, discontinued from marketing or withheld from sale for safety or efficacy. 2

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

SUP 10

Microbiotest, Inc.

Vol #:

149

Attachment

1995N-0071

Proposal to Debar Amirul Islam; Notice of Opportunity for He

LET 5

Zuckerman Spaeder, LLP

Vol #:

1

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 152

McNeil Nutritionals

Vol #:

21

C 153

Yerba Prima, Inc.

Vol #:

25

C 154

ChromaDex

Vol #:

25

C 155

NEC, National Enzyme Co.

Vol #:

25

C 156

LifeTime/Nutritional Specialties, Inc.

Vol #:

25

C 157

AOM Alliance

Vol #:

25

C 158

Formulation Technology, Inc.

Vol #:

25

C 159

Kyowa Hakko USA, Inc.

Vol #:

25

C 160

Herbal Answers, Inc.

Vol #:

25

C 161

Enzyme Technical Assn.

Vol #:

25

C 162

Mead Johnson & Co.

Vol #:

25

C 163

Shaklee Corp.

Vol #:

25

C 164

Natural Technology, Inc.

Vol #:

25

C 165

NSF International

Vol #:

25

C 166

NSF International

Vol #:

25

C 167

Herb Pharm, Inc.

Vol #:

27

C 168

Traditional Medicinals, Inc.

Vol #:

25

C 169

Perrigo Co.

Vol #:

25

C 170

Pacific Botanicals, LLC

Vol #:

25

C 171

Diverstech, Co.

Vol #:

25

C 172

Essential Nutrition, Ltd. et al

Vol #:

26

Exhibit 1, 2, 3, 4

C 173

AARP

Vol #:

25

C 174

Consumer Healthcare Products Assn (CHPA)

Vol #:

25

C 175

Biokoyowa, Inc.

Vol #:

25

C 176

Sweason Health Products

Vol #:

25

C 177

Food Additives Council

Vol #:

25

C 178

Beyond A Century, Inc.

Vol #:

25

C 179

American Herbal Products Assn (AHPA)

Vol #:

25

Attachment 1, 2

C 180

Standard Process (SP)

Vol #:

25

C 181

Select Supplements, Inc.

Vol #:

25

1998N-0359

Program priorities/Center for Food Safety & Applied Nutrition

C 99

Assn of Public Health Laboratories (APHL)

Vol #:

7

C 100

National Food Processors Assn (NFPA)

Vol #:

7

1998P-0610

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

C 52

Institute for Health and Productivity Management (IHPM)

Vol #:

5

2000N-1484

Safety Reporting Requirements Human Drug/Biological Products

C 4

Colgate-Palmolive Co.

Vol #:

3

2000P-1370

ANDA for generic verions of Zaroxolyn Tablets (metolazone

WDL 1

Celltech Americas, Inc.

Vol #:

1

2002N-0534

Medical Device User Fee and Modernization Act of 2002

C 34

Assn of Medical Device Reprocessors (AMDR)

Vol #:

2

C 35

Advanced Medical Technology Assn (AdvaMed)

Vol #:

2

2003D-0165

Current Good Manufacturing Practices for Medical Gases

C 6

Compressed Gas Assn (CGA)

Vol #:

1

2003N-0344

Consumer-Directed Promotion; Public Meeting

NM 1

FDA

Vol #:

1

2003P-0358

Methenex (Methadone Hydrochloride 40 mg,Naloxone Hydrochloride 2 mg) tablets (effervescent) NDA 17-491/NDA 17-490 withdrawn, discontinued from marketing or withheld from sale for safety or efficacy

ACK 1

HFA-305 to Caruso Pharmaceuticals Consultation Services

Vol #:

1

CP 1

Caruso Pharmaceutical Consultation Services

Vol #:

1