Dockets Entered on December 18, 2003

Dockets Management



Dockets Entered On December 18, 2003 Table of Contents



Docket #	Title

1978N-0036L	OTC Laxative

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

2000P-0685	Revise of Yogurt Standards

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

2002D-0371	Human Dura Mater; Class II Special Controls Guidance

2002N-0276	Bioterrorism Preparedness; Registration of Food Facilities

2002N-0278	Bioterrorism; Prior Notice of Imported Food Shipments

2002N-0370	Neurological Devices; Classification of Human Dura Mater

2003D-0465	Guidance for Industry on Providing Regulatory Submissions in Electronic Format b

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

2003D-0493	Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen

2003N-0513	Electronic Submissions of Food Contact Notifications; Notice of Pilot Project

2003P-0275	Reclassify Cyclosporine (CSA) as Non-antibiotic Drug

2003P-0284	Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons

2003V-0527	Laser Light Show

1978N-0036L	OTC Laxative

C 207	Braintree Laboratories	Vol #:	121

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

LET 11930	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11931	Phyto Pharmica Natural Medicines	Vol #:	94

LET 11932	PhytoPharmica Natural Medicines	Vol #:	94

LET 11933	PhytoPharmica Natural Medicines	Vol #:	94

LET 11934	PhytoPharmica Natural Medicines	Vol #:	94

LET 11935	PhytoPharmica Natrual Medicines	Vol #:	94

LET 11936	PhytoPharmica Natural Medicines	Vol #:	94

LET 11937	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11938	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11939	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11940	Bio-Zyme	Vol #:	94

LET 11941	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11942	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11943	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11944	Natural Factors Nutritional Products Inc.	Vol #:	94

LET 11945	Natural Factors Nutritional Products Inc.	Vol #:	94

LET 11946	Natural Factors Nutritional Products Inc.	Vol #:	94



LET 11947	Natural Factors Nutritional Products Inc.	Vol #:	94

LET 11948	DMD Pharmaceuticals	Vol #:	94

LET 11949	PhytoPharmica Natural Medicines	Vol #:	94

LET 11950	PhytoPharmica Natural Medicines	Vol #:	94

LET 11951	Perrigo Company of South Carolina	Vol #:	94

LET 11952	Perrigo Company of South Carolina	Vol #:	94

LET 11953	Perrigo Company of South Carlina	Vol #:	94

LET 11954	Taiko Pharmaceutical Co., Ltd.	Vol #:	94

LET 11955	Herbalist and Alchemist, Inc.	Vol #:	94

LET 11956	Perrigo Company of South Carolina	Vol #:	94

LET 11957	Perrigo Company of South Carolina	Vol #:	94

LET 11958	Enzymatic Therapy Nautral Medicines	Vol #:	94

LET 11959	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11960	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11961	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11962	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11963	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11964	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11965	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11966	Fitness Labs Nutrition Corporation	Vol #:	94

LET 11967	National Vitamin Company, Inc.	Vol #:	94

LET 11968	National Vitamin Company, Inc.	Vol #:	94

LET 11969	PhytoPharmica Natural Medicines	Vol #:	94

LET 11970	PhytoPharmica Natural Medicines	Vol #:	94

LET 11971	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11972	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11973	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11974	McLind Corporation	Vol #:	94

LET 11975	McLind Corporation	Vol #:	94

LET 11976	McLind Corporation	Vol #:	94

LET 11977	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11978	Enzymatic Therapy Natural Medicines	Vol #:	94

LET 11979	PhytoPharmica Natural Medicines	Vol #:	94

LET 11980	Integrative Therapeutics Inc.	Vol #:	94

LET 11981	Cell Tech International Incorporated	Vol #:	94

2000P-0685	Revise of Yogurt Standards



C 11	Dairy Farmers of Canada	Vol #:	1

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

EMC 901	S McKuhen	Vol #:	123

EMC 902	A Snyder	Vol #:	123

EMC 903	C Bond	Vol #:	123

EMC 904	L Day	Vol #:	123

EMC 905	M Buckwalter	Vol #:	123

EMC 906	B Johnson	Vol #:	123

EMC 907	L Hothem	Vol #:	123

EMC 908	R Wilkinson	Vol #:	123

EMC 909	A Navickas	Vol #:	123

EMC 910	W Anderson	Vol #:	123

EMC 911	S Skye	Vol #:	123

EMC 912	J Zlock	Vol #:	123

EMC 913	D di Prima	Vol #:	123

EMC 914	K Quist	Vol #:	123

EMC 915	B Dennis	Vol #:	123

EMC 916	L Bickers	Vol #:	123

EMC 917	M Deal	Vol #:	123

EMC 918	S Smith	Vol #:	123

EMC 919	K Lund	Vol #:	123

EMC 920	D Davidson	Vol #:	123

EMC 921	A Donnelly	Vol #:	123

EMC 922	E Dorbin	Vol #:	123

EMC 923	D Cothern	Vol #:	123

EMC 924	V Starrett	Vol #:	123

EMC 925	S Larsen	Vol #:	123

EMC 926	J Mackow	Vol #:	123

EMC 927	A Alstott	Vol #:	123

EMC 928	B Hayes	Vol #:	123

EMC 929	C Tate	Vol #:	123

EMC 930	T Klein	Vol #:	123

EMC 931	A Moore	Vol #:	123

EMC 932	J Rome	Vol #:	123

EMC 933	D Lenaghan	Vol #:	123

EMC 934	L Stephan	Vol #:	123



EMC 935	C Robinowitz	Vol #:	123

EMC 936	J Steward	Vol #:	123

EMC 937	G Foster	Vol #:	123

EMC 938	R Tomlinson	Vol #:	123

EMC 939	S Modaresi	Vol #:	123

EMC 940	A Ebersole	Vol #:	123

EMC 941	J Dorgan	Vol #:	123

EMC 942	A Stofer	Vol #:	123

EMC 943	R Stockman	Vol #:	123

EMC 944	M Rubio	Vol #:	123

EMC 945	J Schwartz	Vol #:	123

EMC 946	C Braverman	Vol #:	123

EMC 947	A Ross	Vol #:	123

2002D-0371	Human Dura Mater; Class II Special Controls Guidance

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2002N-0276	Bioterrorism Preparedness; Registration of Food Facilities

C 174	Jevic Transportation	Vol #:	17

2002N-0278	Bioterrorism; Prior Notice of Imported Food Shipments

C 242	Geiger	Vol #:	18

EC 338	Sneed, Davin	Vol #:	18

2002N-0370	Neurological Devices; Classification of Human Dura Mater

NFR 1	FDA	Vol #:	1

2003D-0465	Guidance for Industry on Providing Regulatory Submissions in Electronic Format b

C 1	Pharmaceutical Research and Manufacturers of America (PhRMA)	Vol #:	1

EMC 1	Merck & Co., Inc.	Vol #:	1

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

C 42	D Kennedy	Vol #:	2

C 43	PediaMed Pharmaceuticals, Inc.	Vol #:	2

C 44	Breckenridge Pharmaceutical Inc	Vol #:	2

C 45	J Clark	Vol #:	2

EC 13	DiChristina, Salvatore	Vol #:	2

EC 14	Bruhn, Kathleen	Vol #:	2



EC 15	Hintz, Ruth	Vol #:	2

2003D-0493	Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen

C 1	Hikma Pharmaceuticals	Vol #:	1

2003N-0513	Electronic Submissions of Food Contact Notifications; Notice of Pilot Project

C 2	Ciba Specialty Chemicals Corporation	Vol #:	1

2003P-0275	Reclassify Cyclosporine (CSA) as Non-antibiotic Drug

LET 1	HFD-5 to Fish & Richardson and Arnold & Porter	Vol #:	1

2003P-0284	Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons


LET 1	HFD-5 to Lachman Consultant Services, Inc.	Vol #:	1

2003V-0527	Laser Light Show

VRA 1	HFZ-300 to Carnaval Night Club	Vol #:	1

Page created on December 19, 2003 kk
Page update on January 21, 2004 jb

FDA/Dockets Management