Dockets Entered on June 2, 2004

Dockets Management



Dockets Entered On June 2, 2004 Table of Contents



Docket #	Title

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

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

2002P-0414	Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA

2004N-0115	Prescription Drug Importation Study

2004P-0206	No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies

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

LET 14036	Daxen, Inc.	Vol #:	120

LET 14037	Source Naturals	Vol #:	120

LET 14038	Enzymatic Therapy	Vol #:	120

LET 14039	Enzymatic Therapy	Vol #:	120

LET 14040	Flora, Inc.	Vol #:	120

LET 14041	Hansen Beverage Company	Vol #:	120

LET 14042	Lost Beverage Company	Vol #:	120

LET 14043	Monster Beverage Company	Vol #:	120

LET 14044	Blue Sky Beverage Company	Vol #:	120

LET 14045	Monster Beverage Company	Vol #:	120

LET 14046	Hansen Beverage Company	Vol #:	120

LET 14047	Enzymatic Therapy	Vol #:	120

LET 14048	Enzymatic Therapy	Vol #:	120

LET 14049	Enzymatic Therapy	Vol #:	120

LET 14050	Enzymatic Therapy	Vol #:	121

LET 14051	Enzymatic Therapy	Vol #:	121

LET 14052	Enzymatic Therapy	Vol #:	120

LET 14053	Enzymatic Therapy	Vol #:	120

LET 14054	Enzymatic Therapy	Vol #:	120

LET 14055	Enzymatic Therapy	Vol #:	120

LET 14056	Enzymatic Therapy	Vol #:	121

LET 14057	Enzymatic Therapy	Vol #:	121

LET 14058	Enzymatic Therapy	Vol #:	121

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

EXB 52	Center for Veterinary Medicine	Vol #:	407

EXB 53	Center for Veterinary Medicine	Vol #:	407

EXB 54	Center for Veterinary Medicine	Vol #:	407

EXB 55	Center for Veterinary Medicine	Vol #:	407

EXB 56	Center for Veterinary Medicine	Vol #:	407



EXB 57	Center for Veterinary Medicine	Vol #:	407

EXB 58	Center for Veterinary Medicine	Vol #:	407

EXB 59	Center for Veterinary Medicine	Vol #:	407

EXB 60	Center for Veterinary Medicine	Vol #:	408

EXB 61	Center for Veterinary Medicine	Vol #:	408

EXB 62	Center for Veterinary Medicine	Vol #:	408

EXB 63	Center for Veterinary Medicine	Vol #:	408

EXB 64	Center for Veterinary Medicine	Vol #:	408

EXB 65	Center for Veterinary Medicine	Vol #:	408

EXB 66	Center for Veterinary Medicine	Vol #:	408

EXB 67	Center for Veterinary Medicine	Vol #:	408

EXB 68	Center for Veterinary Medicine	Vol #:	408

EXB 69	Center for Veterinary Medicine	Vol #:	408

2002P-0414	Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA

ACK 2	HFA-305 to The Weinberg Group Inc.	Vol #:	1

PRC 1	The Weinberg Group Inc.	Vol #:	1

2004N-0115	Prescription Drug Importation Study

APE 20	Latinos Unidos Health Access Alliance & National Lulac Labor Advisor	Vol #:	13

APE 21	Group Benefits Strategies	Vol #:	13

APE 22	State of Wisconins	Vol #:	14

C 11 Cover Letter, Appendix	Pharmaceutical Research and Manufacturers of America (PhRMA)	Vol #:	11

C 12	Christensen, Miller, FInk, Jacobs, Glaser, Weil & Shapiro LLP	Vol #:	11

C 13	King Pharmaceuticals, Inc	Vol #:	13

C 14	American Academy of Pharmaceutical Physicians	Vol #:	14

C 15	Schering-Plough Corporation	Vol #:	13

C 16	Pacific Research Institute	Vol #:	13

C 17	McKesson Corporation	Vol #:	14

C 18	State of Minnesota	Vol #:	14

C 19	Roy E Smythe	Vol #:	14

C 20	NAMI (National Alliance for the Mentally Ill)	Vol #:	14

C 21	American Society of Health-System Pharmacists	Vol #:	14

C 22	Gary J Moss	Vol #:	14

C 23	H Schouweiler	Vol #:	14

C 24	D Cantor	Vol #:	14

C 25	E Kaplan MD	Vol #:	14



C 26	Canadian International Pharmacy Association	Vol #:	14

C 27	Hoffmann-La Roche Inc	Vol #:	14

EC 51	Pharmaceutical Security Institute	Vol #:	14

EC 52	Aurora Health Care	Vol #:	14

EC 53	American Academy of Pharmaceutical Physicians	Vol #:	14

EC 54	Dr. Jeffrey Greenberg	Vol #:	14

EMC 18	Health Canada	Vol #:	13

EMC 19	Healthcare Distribution Management Association	Vol #:	14

EMC 20	Cancer Research and Prevention Foundation	Vol #:	14

LET 1	State of Minnesota	Vol #:	14

LET 2	University of Arizona Health Sciences Center	Vol #:	14

LET 3	Congress of the United States	Vol #:	14

LET 4	Goernment of Province of Quebec, Canada	Vol #:	14

LET 5	Congress of the United States, House of Representatives	Vol #:	14

LET 6	Health Canada	Vol #:	14

TR 4	Transcript of the April 14, 2004 Public Meeting	Vol #:	15

TR 5	Transcript of the April 27, 2004 Public Meeting (International and Academic Perspectives)	Vol #:	16

TR 6	Transcript of the May 5, 2004 Health Care Purchasers	Vol #:	17

TR 7 Continued	Transcript of the May 14, 2004	Vol #:	18

TS 56	Barr Pharmaceuticals Inc	Vol #:	13

TS 57	Biotechnology Industry Organization	Vol #:	13

TS 58	Generic Pharmaceutical Association (GPhA)	Vol #:	13

TS 59	Healthcare Distribution Management Association	Vol #:	13

TS 60	National Association of Chain Drug Stores Inc	Vol #:	13

TS 61	Pharmaceutical Distributors Association	Vol #:	13

TS 62	Global Security, Pfizer Inc	Vol #:	13

TS 63	Serona Inc	Vol #:	13

TS 64	Authentix	Vol #:	13

TS 65	Parents of Food Allergic Kids (POFAK)	Vol #:	13

TS 66	Small Business Survival Committee	Vol #:	13

TS 67	American Enterprise Institute	Vol #:	24

TS 68	Patricia M Danzon PhD	Vol #:	13

TS 69	Columbia University and National Bureau of Economic Research	Vol #:	13

TS 70	National Association of Pharmacy Regulatory Authorities (NAPRA)	Vol #:	13

TS 71	Vanderbilt University School of Medicine	Vol #:	13

TS 72	Quebec Order of Pharmacists	Vol #:	13

TS 73	Manitoba Pharmaceutical Association	Vol #:	14



TS 74	Iowa Department of Human Services	Vol #:	14

TS 75	State of Maine, National Associaiton of Attorneys General	Vol #:	14

TS 76	National Conference of State Legislatures	Vol #:	14

TS 77	American Academyu of Nurse Practitioners	Vol #:	14

TS 78	60 Plus Association	Vol #:	14

TS 79	Public Citizen's Health Research Group	Vol #:	14

TS 80 Continued	Cornell University	Vol #:	14

2004P-0206	No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies

C 1	GlaxoSmithKline (GSK)	Vol #:	2

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FDA/Dockets Management