Dockets Entered on October 22, 2003

Dockets Management



Dockets Entered On October 22, 2003 Table of Contents



Docket #	Title

1976N-0052N	OTC Nasal Decongestants

1978N-0036L	OTC Laxative

1981N-0022	OTC Weight Control Drug Products for Human Use

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

2002P-0120	Request the immediate ban of Meridia (sibutramine)

2003D-0290	Compounding of Drugs for Use in Animals Compliance Policy Guide

2003D-0412	International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

2003N-0472	Statement of Work for the Evaluation of First Cycle Review Performance; Availability

1976N-0052N	OTC Nasal Decongestants

MT 12	D. DeLap, Ms. Walling/FDA and Dr. Walter Kerman/Yale U	Vol #:	77

1978N-0036L	OTC Laxative

LET 201	HFD-560 to Purdue Pharma, LP	Vol #:	121

1981N-0022	OTC Weight Control Drug Products for Human Use

MT 9	Dr. DeLap, Ms. Walling/FDA and Dr. Walter Kerman/Yale U.	Vol #:	95

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

LET 11295	Botanical Laboratories, Inc.	Vol #:	86

LET 11296	Botanical Laboratories, Inc.	Vol #:	86

LET 11297	Botanical Laboratories, Inc.	Vol #:	86

LET 11298	Solstice Medicine Company	Vol #:	86

LET 11299	Your Vitamins	Vol #:	86

LET 11300	Your Vitamins	Vol #:	86

LET 11301	Your Vitamins	Vol #:	86

LET 11302	Solgar Vitamin & Herbs	Vol #:	86

LET 11303	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11304	PhytoPharmica Natural Medicines	Vol #:	86

LET 11305	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11306	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11307	Natural 2U, LLC	Vol #:	86

LET 11308	NOW Foods	Vol #:	86

LET 11309	NOW FOODS	Vol #:	86

LET 11310	NOW FOODS	Vol #:	86

LET 11311	Perrigo Company of South Carolina	Vol #:	86

LET 11312	Perrigo Company of South Carolina	Vol #:	86



LET 11313	Perrigo Company of South Carolina	Vol #:	86

LET 11314	Perrigo Company of South Carolina	Vol #:	86

LET 11315	Standard Process Inc.	Vol #:	86

LET 11316	Standard Process Inc.	Vol #:	86

LET 11317	Global Chinese herbs Depot, Inc.	Vol #:	86

LET 11318	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11319	Perrigo Company of South Carolina	Vol #:	86

LET 11320	Perrigo Company of South Carolina	Vol #:	86

LET 11321	Natural Factors Nutritional Products Inc.	Vol #:	86

LET 11322	Natural Factors Nutritional Products Inc.	Vol #:	86

LET 11323	Phytomer Corp.	Vol #:	86

LET 11324	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11325	Millennium Biotechnologies, Inc.	Vol #:	86

LET 11326	Millennium Biotechnologies, Inc.	Vol #:	86

LET 11327	Bayer Corporation	Vol #:	87

LET 11328	NOW FOODS	Vol #:	87

LET 11329	A.L.A. Corporation	Vol #:	87

LET 11330	A.L.A. Corporation	Vol #:	87

LET 11331	Natural Organics Inc.	Vol #:	87

LET 11332	Natural Organics Inc.	Vol #:	87

LET 11333	Natural Organics Inc.	Vol #:	87

LET 11334	Natural Organics Inc.	Vol #:	87

LET 11335	Natural Organics Inc.	Vol #:	87

LET 11336	Natural Organics Inc.	Vol #:	87

2002P-0120	Request the immediate ban of Meridia (sibutramine)

C 4 Tab A	Abbott Laboratories (Abbott)	Vol #:	1

2003D-0290	Compounding of Drugs for Use in Animals Compliance Policy Guide

C 1	Janet M. Grossnickle	Vol #:	1

2003D-0412	International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

C 4	Abbott Laboratories	Vol #:	1

2003N-0472	Statement of Work for the Evaluation of First Cycle Review Performance; Availability

BKG 1	Background Material	Vol #:	1

NAD 1	FDA	Vol #:	1

FDA/Dockets Management