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| Dockets Entered
On August 20, 2004
Table of Contents
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| Docket #
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| Title
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0372
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| ANADA suitability for generic carprofen chewable tablet
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| 2004P-0373
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| ANDA for Omeprazole Magnesium Delayed Release Capsules,Eq. to 20 mg base for OTC
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| ACK
4
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| HFA-305 to American Herbal Products Assnociation
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| Vol #:
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| 1
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| PSA
1
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| American Herbal Products Assnociation
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| Vol #:
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| 398
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7445
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| R. Cross
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| Vol #:
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| 307
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| C 7446
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| M. Edelweisne
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| Vol #:
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| 307
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| C 7447
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| P. Dasgupta
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| Vol #:
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| 307
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| C 7448
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| J. K. Tew
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| Vol #:
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| 307
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| EMC 4255
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| K. Lange
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| Vol #:
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| 304
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| EMC 4256
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| ldumon@united.com
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| Vol #:
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| 304
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| EMC 4257
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| P. Williams
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| Vol #:
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| 204
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| EMC 4258
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| A. Ruggiero
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| Vol #:
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| 304
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| EMC 4259
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| N. Palen
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| Vol #:
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| 304
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| EMC 4260
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| D. Artley
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| Vol #:
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| 304
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| EMC 4261
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| G. Madaffari
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| Vol #:
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| 304
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| EMC 4262
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| D. Mitchell
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| Vol #:
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| 304
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| EMC 4263
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| S. Suozzo
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| Vol #:
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| 304
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| EMC 4264
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| D. S. Tanner
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| Vol #:
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| 304
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| EMC 4265
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| K. Munger
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| Vol #:
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| 304
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| EMC 4266
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| L. Pesteanu
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| Vol #:
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| 304
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| EMC 4267
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| M. Carter
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| Vol #:
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| 304
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| EMC 4268
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| C. Johnson
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| Vol #:
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| 304
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| EC
2
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| American Frozen Food Institute
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| Vol #:
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| 1
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| EC
3
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| American Frozen Food Institute
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| Vol #:
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| 1
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| | | | | | | | |
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| LST
1
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| Agenda for GMP Modernization Public Meeting, July 21, 2004, Chicago, IL
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| Vol #:
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| 1
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| LST
2
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| List of Attendees, July 21, 2004, Chicago, IL
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| Vol #:
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| 1
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| TR
1
Continued
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| Transcript of the July 19, 2004 GMP Modernization Public Meeting
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| Vol #:
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| 2
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| TR
2
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| Transcript of the July 31, 2004 GMP Modernization Public Meeting, Chicago, IL
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| Vol #:
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| 3
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| TS
1
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| Food Allergy & Anaphylaxis Network (FAAN)
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| Vol #:
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| 1
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| C 122
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| Vicki C
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| Vol #:
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| 22
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| C 123
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| D E Smith
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| Vol #:
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| 22
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| C
124
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| Embassy of Australia
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| Vol #:
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| 22
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| C
125
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| Association of American Feed Control Officials Inc (AAFCO)
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| Vol #:
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| 22
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| C
126
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| Fats and Proteins Research Foundation Inc
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| Vol #:
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| 22
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| C 127
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| J Morrell
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| Vol #:
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| 22
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| C 128
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| N Kueberth
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| Vol #:
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| 22
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| C 129
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| L Cohen
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| Vol #:
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| 22
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| EC
5
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| National Milk Producers Federation
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| Vol #:
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| 22
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| EC
6
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| McDonald's Corporation
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| Vol #:
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| 22
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| EC 7
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| Mr. Justin Marx
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| Vol #:
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| 22
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| EC
8
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| Organic Consumers Association
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| Vol #:
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| 22
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| EC 9
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| Ms. Lydia Heard
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| Vol #:
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| 22
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| EC 10
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| none
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| Vol #:
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| 2
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| EC 11
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| none
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| Vol #:
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| 2
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| EC
12
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| PhRMA
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| Vol #:
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| 22
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| EC 13
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| Ms. Mary Stewart
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| Vol #:
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| 22
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| EC 14
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| Ms. Arlyn Newcomb
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| Vol #:
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| 22
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| EC 15
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| Ms. Karen Siegel
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| Vol #:
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| 22
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| EC 16
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| Dakota Resource Council
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| Vol #:
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| 2
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| EC 17
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| Ms. Linda Michaels
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| Vol #:
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| 22
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| EMC 1369
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| The Holmes Family
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| Vol #:
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| 19
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| EMC
1370
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| Embassy of Australia
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| Vol #:
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| 19
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| EMC
1371
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| Embassy of Australia
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| Vol #:
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| 19
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| EMC 1372
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| P Medeiros
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| Vol #:
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| 19
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| EMC 1373
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| DK Forbes
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| Vol #:
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| 19
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| EMC 1374
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| D Walsh
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| Vol #:
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| 19
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| EMC 1375
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| R DeGreenia
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| Vol #:
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| 19
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| EMC 1376
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| K Wochinger
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| Vol #:
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| 19
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| EMC
1377
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| Cargill, Pacific Northwest District
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| Vol #:
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| 19
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| | | | | | | | |
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| EMC 1378
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| D Shohan
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| Vol #:
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| 19
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| EMC 1379
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| T Spires
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| Vol #:
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| 19
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| EMC 1380
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| S Quaintance
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| Vol #:
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| 19
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| EMC 1381
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| K Hufnagel
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| Vol #:
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| 19
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| EMC
1382
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| Pacific Northwest District
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| Vol #:
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| 19
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| EMC 1383
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| R Berghofer
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| Vol #:
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| 19
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| EMC 1384
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| C Smith
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| Vol #:
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| 19
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| EMC 1385
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| J Wintersgill
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| Vol #:
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| 19
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
|
|
|
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| C
5
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| Pepsico
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| Vol #:
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| 1
|
|
|
|
|
| 2004P-0113
|
| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
|
|
|
|
|
| C
3
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| School of Pharmacy, University of Bradford
|
| Vol #:
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| 1
|
|
|
|
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| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
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| C
3
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| California Healthcare Institute
|
| Vol #:
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| 1
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|
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| 2004P-0372
|
| ANADA suitability for generic carprofen chewable tablet
|
|
|
|
|
| ACK
1
|
| HFA-305 to Intervet Inc.
|
| Vol #:
|
| 1
|
|
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| CP
1
|
| Intervet Inc.
|
| Vol #:
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| 1
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|
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|
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| 2004P-0373
|
| ANDA for Omeprazole Magnesium Delayed Release Capsules,Eq. to 20 mg base for OTC
|
|
|
|
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| ACK
1
|
| Gray Cary Ware & Freidenrich LLP
|
| Vol #:
|
| 1
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| CP
1
|
| Gray Cary Ware & Freidenrich LLP
|
| Vol #:
|
| 1
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