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| Dockets Entered
On July 8, 2004
Table of Contents
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| Docket #
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| Title
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| |
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| 2002V-0382
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| Infrared Laser Aiming Devices
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0233
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004D-0182
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| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| |
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| |
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| 2004N-0217
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| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| 2004P-0008
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| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
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| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| |
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| |
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| 2004S-0170
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
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| 2004V-0240
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| Projector for a Laser Light Show
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| 2004V-0241
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| Projector for a Laser Light Show
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| 2004V-0288
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| Laser Light Show
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| C
90
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| Center for research on Environmental Microbiology (CREM)
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| Vol #:
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| 200
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| C
62
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| National Nutritional Foods Assn (NNFA)
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| Vol #:
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| 5
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| C
63
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 5
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| C
64
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| Pharmavite, LLC
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| Vol #:
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| 5
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| EXT
7
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 5
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| C
79
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| National Nutritional Foods Assn (NNFA)
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| Vol #:
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| 5
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| C
80
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 5
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| C
81
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| Pharmavite, LLC
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| Vol #:
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| 5
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| EXT
8
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 5
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7439
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| E. Borggren
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| Vol #:
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| 307
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| |
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| C 7440
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| M. Mefford
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| Vol #:
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| 307
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| |
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| C 7441
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| B. Hemauer
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| Vol #:
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| 307
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| C 7442
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| A. Hemauer
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| Vol #:
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| 307
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| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
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| |
|
|
| EXB 216
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| |
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| EXB 217
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| |
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| EXB 218
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| |
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| EXB 219
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| |
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| EXB 220
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| |
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| EXB 221
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 222
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 223
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 224
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 225
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 226
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 227
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 228
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 229
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 230
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 231
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 232
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 233
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 234
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 235
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 236
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 237
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 238
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 239
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 240
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 241
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| Center for Veterinary Medicine
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| Vol #:
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| 418
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| 2000P-1275
|
| Health Claim: Vegetable oil sterol esters & coronary heart d
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| |
|
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| C
27
Attachment
|
| Cargill Health and Food Technologies
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| Vol #:
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| 22
|
| |
|
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| 2000P-1276
|
| Health Claim: Plant stanol esters and heart disease
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| |
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| C
31
Attachment
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| Cargill Health and Food Technologies
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| Vol #:
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| 22
|
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
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| C 1870
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| N. Bourdon
|
| Vol #:
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| 281
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| C 1871
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| Mr and Mrs J. McBride
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| Vol #:
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| 281
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| C 1872
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| K. Schwiebert
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| Vol #:
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| 281
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| C
1873
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| The Pharmacy Access Partnership
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| Vol #:
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| 281
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| C
1874
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| American Civil Liberties Union (ACLU)
|
| Vol #:
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| 281
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| |
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|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
| |
|
|
| LET
2
|
| Terumo Medical Corporation (Terumo)
|
| Vol #:
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| 2
|
| |
|
|
| 2002V-0382
|
| Infrared Laser Aiming Devices
|
| |
|
|
| LET
2
|
| HFZ-300 to Laser Devices, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| C
22
|
| GlaxoSmithKline (GSK)
|
| Vol #:
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| 2
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| |
|
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| C
23
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| Merck KGaA, Germany
|
| Vol #:
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| 2
|
| |
|
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| C
24
|
| Pfizer
|
| Vol #:
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| 2
|
|
| |
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| C
31
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
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| 8
|
| |
|
|
| 2003N-0233
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
|
| |
|
|
| SUP
2
|
| BASF AG
|
| Vol #:
|
| 3
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| C
15
|
| Stanislaus County Public Health Services
|
| Vol #:
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| 2
|
| |
|
|
| C 16
|
| E. Bersin
|
| Vol #:
|
| 2
|
| |
|
|
| C
17
|
| Health Services Agency
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| C 18
|
| V. McLain, RN
|
| Vol #:
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| 2
|
| |
|
|
| 2004D-0182
|
| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
|
| |
|
|
| C
1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
| |
|
|
| C
3
|
| Hoffman-LaRoche, Inc. (Roche)
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Novartis Pharmaceuticals, Corp. (Novartis)
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| Abbott Laboratories (Abbott)
|
| Vol #:
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| 1
|
| |
|
|
| C
7
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
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| 1
|
| |
|
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
| |
|
|
| C
3
|
| Hoffmann-La Roche, Inc.
|
| Vol #:
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| 1
|
| |
|
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| C
4
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Novartis Pharmaceuticals, Corp. (Novartis)
|
| Vol #:
|
| 1
|
| |
|
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| C
6
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 1
|
| |
|
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| C
7
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
| |
|
|
| C
3
|
| Hoffmann-La Roche, Inc. (Roche)
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Novartis Pharmaceuticals, Corp. (Novartis)
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
| |
|
|
| C
7
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| C
11
|
| National Electrical Manufacturers Assn (NEMA)
|
| Vol #:
|
| 4
|
| |
|
|
| C
12
|
| Cerner Corporation
|
| Vol #:
|
| 4
|
| |
|
|
| C
13
|
| BOC Gases
|
| Vol #:
|
| 4
|
| |
|
|
| C
14
|
| ISPE/GAMP
|
| Vol #:
|
| 4
|
| |
|
|
| C
15
|
| Gas Regs, Inc.
|
| Vol #:
|
| 4
|
|
| |
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
| |
|
|
| C
4
|
| National Cooperation for Laboratory Accreditation (NACLA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0194
|
| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
|
|
| | | | | | | | |
| |
|
|
| C
1
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0217
|
| Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
|
| |
|
|
| LET
2
|
| HFS-800 to Advocates for Better Children's Diets
|
| Vol #:
|
| 1
|
| |
|
|
| LET
3
|
| HFS-800 to Shape Up America!
|
| Vol #:
|
| 1
|
| |
|
|
| LET
4
|
| HFS-800 to American Institute for Cancer Research
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0221
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
| |
|
|
| LET
1
|
| Honorable Sherwood Boehlert
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0008
|
| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
|
| |
|
|
| LET
1
|
| HFS-300 to Cancer Action NY
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0107
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
| |
|
|
| LET
2
|
| ConAgra Foods
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
| |
|
|
| C
2
|
| Johnson & Johnson (J&J)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0290
|
| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
|
| |
|
|
| ACK
1
|
| HFA-305 to GlaxoSmithKline Research & Development
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Tab
1, 2, 3,
4
|
| GlaxoSmithKline Research & Development
|
| Vol #:
|
| 1
|
| |
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
| |
|
|
| C
3
|
| American Dental Assn (ADA) et al.
|
| Vol #:
|
| 3
|
| |
|
|
| C
4
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 3
|
| |
|
|
| C
5
Attachment
|
| Opt-e-scrip, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| 2004V-0240
|
| Projector for a Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Crown & Anchor
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0241
|
| Projector for a Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Sergio Gonzalez
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0288
|
| Laser Light Show
|
| |
|
|
| ACK
1
|
| HFA-305 to Luxor Hotel & Casino
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Luxor Hotel & Casino
|
| Vol #:
|
| 1
|
|
|
