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| Dockets Entered
On December 23, 2003
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2001P-0572
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| Petition for Regulation of Ariva Tobacco Lozenges
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| 2001P-0573
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| Petition for Regulation of S & F Nicotine Water
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0448
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| ANDA Sutability for Albuterol Base Inhalation Solution
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols - Protein Drug Products and Biologic Products - Chemistry, Manufacturing, and Controls Information
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| 2003D-0465
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003N-0338
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| Obesity
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| 2003P-0083
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| ANDA suitability for carbamazepine tablets, 100mg, 300mg,400
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| 2003P-0216
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| ANDA for a drug product(1.5 mg levonorgestrel tablet) in strength(Plan B 0.75 mg Levonorgestrel tablet) in strength
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| 2003P-0238
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| ANDA Suitability Petition for Clarithromycin Extended-Release Tablets
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| 2003P-0275
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| Reclassify Cyclosporine (CSA) as Non-antibiotic Drug
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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11990
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| Now Foods
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| Vol #:
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| 94
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| LET
11991
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| Now Foods
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| Vol #:
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| 94
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| LET
11992
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| FBL Sciences, LLC
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| Vol #:
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| 96
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| LET
11993
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| Rexall Sundown
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| Vol #:
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| 96
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| LET
11994
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| Rexall Sundown,Inc.
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| Vol #:
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| 96
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| LET
11995
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| Solstice Medicine Company
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| Vol #:
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| 96
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| LET
11996
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| Solstice Medicine Company
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| Vol #:
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| 96
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| LET
11997
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| Solstice Medicine Company
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| Vol #:
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| 96
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| LET
11998
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| Oregon's Wild Harvest
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| Vol #:
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| 96
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| LET
11999
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| Natural Organics Inc.
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| Vol #:
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| 96
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| LET
12000
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| Natural Organics Inc.
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| Vol #:
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| 96
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| LET
12001
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| Natural Organics Inc.
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| Vol #:
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| 94
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| LET
12002
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 94
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| LET
12003
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 96
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| LET
12004
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 96
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| LET
12005
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 96
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| LET
12006
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 96
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| LET
12007
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 96
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7333
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| Rachael Lyon
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| Vol #:
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| 305
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| 2001P-0572
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| Petition for Regulation of Ariva Tobacco Lozenges
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| LET
4
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| QT5, Inc.
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| Vol #:
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| 3
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| 2001P-0573
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| Petition for Regulation of S & F Nicotine Water
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| LET
2
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| QT5, Inc.
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| Vol #:
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| 1
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| C
176
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| European Union Delegation of the European Commission
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| Vol #:
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| 17
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| C
177
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| Embassy of Japan
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| Vol #:
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| 17
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| C
178
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| Flavor and Extract Manufacturers Assn (FEMA)
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| Vol #:
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| 17
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| C
179
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| Comite Interprofessionnel Du Vin de Champagne
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| Vol #:
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| 17
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| C
180
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| American Bakers Assn (ABA)
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| Vol #:
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| 17
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| C
181
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| Canadian Embassy
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| Vol #:
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| 17
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| C
182
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| Center for Science in the Public Interest
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| Vol #:
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| 18
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| C
183
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| American Seed Trade Association, Inc (ASTA)
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| Vol #:
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| 18
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| C
184
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| American Free Trade Association
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| Vol #:
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| 18
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| C
185
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| International Food Coalition
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| Vol #:
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| 18
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| C
186
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| Pokon & Chrysal (P&C)
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| Vol #:
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| 18
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| C
187
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| Hoffmann-La Roche Inc
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| Vol #:
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| 18
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| C
188
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| Taylor & Grant
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| Vol #:
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| 18
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| C
189
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| Federal Express Corporation (FedEx)
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| Vol #:
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| 18
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| C
190
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| American Frozen Food Institute (AFFI)
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| Vol #:
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| 18
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| C
191
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| American Feed Industry Association (AFIA)
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| Vol #:
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| 18
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| C
192
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| International Foodservice Distributors Association (IFDA)
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| Vol #:
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| 18
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| C
193
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| National Confectioners Association (NCA)
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| Vol #:
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| 18
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| EC 328
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| Tadgerson, Danny
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| Vol #:
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| 18
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| EC 329
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| Baker Pineda, Juan Carlos
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| Vol #:
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| 18
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| EC 330
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| Jones, Elizabeth
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| Vol #:
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| 18
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| EC 331
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| Klevgard, Paul
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| Vol #:
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| 18
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| EMC
108
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| Confederation of the EU Food & Drink
Industries (CIAA)
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| Vol #:
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| 18
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| EMC
109
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| Comite Interprofessionnel du Vin de Champagne
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| Vol #:
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| 18
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| EMC
110
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| Animal Nutrition Association of Canada (ANAC)
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| Vol #:
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| 18
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| EMC
111
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| Teepak LLC
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| Vol #:
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| 18
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| EMC
112
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| Government of Japan
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| Vol #:
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| 18
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| EMC
113
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| World Shipping Council
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| Vol #:
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| 18
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| EMC
114
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| Air Courier Conference of America, International
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| Vol #:
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| 18
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| EMC
115
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| Monsanto Company
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| Vol #:
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| 18
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| EMC
116
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| Canadian Produce Marketing Association
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| Vol #:
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| 18
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| |
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| C
245
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| European Union Delegation of the European Commission
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| Vol #:
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| 19
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| C
246
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| Embassy of Japan
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| Vol #:
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| 19
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| C
247
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| Flavor and Extract Manufacturers Assn (FEMA)
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| Vol #:
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| 19
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| C
248
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| American Bakers Assn (ABA)
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| Vol #:
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| 19
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| C
249
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| Canadian Embassy
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| Vol #:
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| 19
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| C
250
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| Grocery Manufacturers of America (GMA)
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| Vol #:
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| 19
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| EC 339
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| Hook, David
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| Vol #:
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| 19
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| EC 340
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| Weisl, Gerald
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| Vol #:
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| 19
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| EC 341
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| Walker, Ian
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| Vol #:
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| 19
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| EC 342
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| Bresters, Tiddo
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| Vol #:
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| 19
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| EC 343
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| Orr, Nadine
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| Vol #:
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| 19
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| EC 344
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| Boyanton, Earl
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| Vol #:
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| 19
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| EC 345
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| McQueary, Steve
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| Vol #:
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| 19
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| EC 346
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| Stephanian, Sarah
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| Vol #:
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| 19
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| EC 347
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| Baker Pineda, Juan Carlos
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| Vol #:
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| 19
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| EC 348
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| Fredette, James
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| Vol #:
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| 19
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| EC 349
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| Arosemena, Dalva
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| Vol #:
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| 19
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| EC 350
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| Alexander, Corinne
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| Vol #:
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| 19
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| EMC
128
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| The Fertilizer Institute
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| Vol #:
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| 19
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| EMC
129
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| Confederation of the EU Food and Drink Industries (CIAA)
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| Vol #:
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| 19
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| EMC
130
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| Comite Interprofessionnel du vin de Champagne (CIVC)
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| Vol #:
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| 19
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| EMC
131
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| Animal Nutrition Association of Canada (ANAC)
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| Vol #:
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| 19
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| EMC
132
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| Teepak LLC
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| Vol #:
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| 19
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| EMC
133
Attachment
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| Government of Japan
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| Vol #:
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| 19
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| EMC
134
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| Grocery Manufacturers of America (GMA)
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| Vol #:
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| 19
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| EMC
135
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| Kinnikinnick Foods Inc.
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| Vol #:
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| 19
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| EMC
136
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| World Shipping Council
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| Vol #:
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| 20
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| EMC 137
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| W Arthur
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| Vol #:
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| 20
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| EMC
138
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| Air Courier Conference of America (ACCA)
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| Vol #:
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| 20
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| EMC
139
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| Monsanto Company
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| Vol #:
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| 20
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| EMC
140
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| Canadian Produce Marketing Association (CPMA)
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| Vol #:
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| 20
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| EMC
141
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| Western Grain Elevator Association
|
| Vol #:
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| 20
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| |
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| 2002P-0448
|
| ANDA Sutability for Albuterol Base Inhalation Solution
|
| |
|
|
| PDN
1
|
| HFD-600 to SensorMedics Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0385
|
| Guidance for Industry: Comparability Protocols - Protein Drug Products and Biologic Products - Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| C
8
|
| Bristol-Myers Squibb Company
|
| Vol #:
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| 1
|
| |
|
|
| 2003D-0465
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
|
| |
|
|
| C
2
|
| Animal Health Institute (AHI)
|
| Vol #:
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| 1
|
| |
|
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| |
|
|
| C
49
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| Purdue Pharma, LP (Purdue)
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| Vol #:
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| 2
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| C
50
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| Zyber Pharmaceuticals
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| Vol #:
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| 2
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| C
51
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| Healthpoint, Ltd
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| Vol #:
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| 2
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| C
52
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| King Pharmaceuticals, Inc. (King)
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| Vol #:
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| 2
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| C
53
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| PFab, LP, d/b/a PharmaFab
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| Vol #:
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| 2
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| |
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| C
54
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| Galderma Laboratories, LP (Galderma)
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| Vol #:
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| 2
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| |
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| C
55
|
| Form Letter
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| Vol #:
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| 3
|
| |
|
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| 2003N-0338
|
| Obesity
|
| |
|
|
| C
13
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
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| 7
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| |
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| C
14
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| The Weston A. Price Foundation
|
| Vol #:
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| 7
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| C
15
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| Bureau of Consumer Protection,Bureau of Economics,and the Office of Policy Planning of the FTC
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| Vol #:
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| 7
|
| |
|
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| SUP
1
Participant
list, CVs, Attachments
|
| Exploring the Link Between Food Labeling and Weight Management
|
| Vol #:
|
| 9
|
| |
|
|
| 2003P-0083
|
| ANDA suitability for carbamazepine tablets, 100mg, 300mg,400
|
| |
|
|
| PAV
1
|
| HFD-600 to Taro Pharmaceuticals, U.S.A., Inc.
|
| Vol #:
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| 1
|
| |
|
|
| 2003P-0216
|
| ANDA for a drug product(1.5 mg levonorgestrel tablet) in strength(Plan B 0.75 mg Levonorgestrel tablet) in strength
|
| |
|
|
| PDN
1
|
| HFD-600 to HRA Pharma
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0238
|
| ANDA Suitability Petition for Clarithromycin Extended-Release Tablets
|
| |
|
|
| PAV
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0275
|
| Reclassify Cyclosporine (CSA) as Non-antibiotic Drug
|
| |
|
|
| PDN
1
|
| HF-22 to Fish & Richardson, PC and Arnold & Porter
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0366
|
| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
|
| |
|
|
| C
2
Exhibit
A, B,
C, D,
E,
F, G
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| Mylan Pharmaceuticals, Inc. (Mylan)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| SUP
2
Attached CV
|
| Mylan Phamaceuticals, Inc. (Mylan)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
| |
|
|
| SUP
1
Tab A,
B
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
|
|
