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| Dockets Entered
On Octover 7, 2003
Table of Contents
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| Docket #
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| Title
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| 1987F-0179
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| Sucrose polyester as replacement for fats & oil in food
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-1146
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| Microbial effects of antimicrobial new animal drugs/human sa
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000P-0685
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| Revise of Yogurt Standards
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2003D-0228
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 - Reviewable Units for Fast Track Products Under PDUFA
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2003D-0263
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| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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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-0213
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| Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
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| 2003N-0286
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| Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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| 2003N-0324
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| Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| 2003N-0425
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| Agency Information Collection Activities: Proposed Collection; Comment Request
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| 2003P-0220
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| ANDA for Carboplatin, 10mg/mL, in strength of 600 mg/60 mL
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| 2003P-0227
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| ANDA Suitability Petition for Cefoxitin
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| 2003P-0237
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| ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0408
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| Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets
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| 1987F-0179
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| Sucrose polyester as replacement for fats & oil in food
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| NCR
2
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| FDA
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| Vol #:
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| 41
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| EMC 919
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| Philip Daniel
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| Vol #:
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| 375
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| EMC 920
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| Pam Koss
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| Vol #:
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| 375
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| EMC 921
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| Gino Santangelo
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| Vol #:
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| 375
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11136
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| Carlson
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| Vol #:
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| 85
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| LET
11137
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| Carlson
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| Vol #:
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| 85
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| LET
11138
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| Carlson
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| Vol #:
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| 85
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| LET
11139
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| Carlson
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| Vol #:
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| 85
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| LET
11140
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| Basic Research, LLC
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| Vol #:
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| 85
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| LET
11141
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| Basic Research
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| Vol #:
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| 85
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| LET
11142
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| Carlson
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| Vol #:
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| 85
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| LET
11143
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| Carlson
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| Vol #:
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| 85
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| LET
11144
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| Carlson
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| Vol #:
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| 85
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| LET
11145
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| Carlson
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| Vol #:
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| 85
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| LET
11146
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| Carlson
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| Vol #:
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| 85
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| LET
11147
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| Carlson
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| Vol #:
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| 85
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| LET
11148
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| Carlson
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| Vol #:
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| 85
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| LET
11149
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| Carlson
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| Vol #:
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| 85
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| LET
11150
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| Nerw York Healthy Herbs Inc.
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| Vol #:
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| 85
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| LET
11151
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11152
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11153
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11154
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11155
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11156
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11157
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| Nature's Life
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| Vol #:
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| 85
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| LET
11158
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| Nature's Life
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| Vol #:
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| 85
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| LET
11159
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| Nature's Life
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| Vol #:
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| 85
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| LET
11160
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11161
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 85
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| LET
11162
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| Indian Botanic Gardens, Inc.
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| Vol #:
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| 85
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| LET
11163
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| Weider Nutritional International , Inc.
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| Vol #:
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| 85
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| 1998D-1146
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| Microbial effects of antimicrobial new animal drugs/human sa
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| EMC 697
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| Kristina Jones
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| Vol #:
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| 19
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| EMC 698
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| Carolyn J. Shelton
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| Vol #:
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| 19
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| EMC 699
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| Ananya Mullane
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| Vol #:
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| 19
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| EMC 700
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| Jim Ciha
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| Vol #:
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| 19
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4057
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| Jane Floege
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| Vol #:
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| 514
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| C
2
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| National Food Processors Assn (NFPA)
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| Vol #:
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| 1
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| LET
2
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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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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| EMC 3
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| Eduardo J. Rubiera
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| Vol #:
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| 1
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| EMC 4
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| Dan Tracy
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| Vol #:
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| 1
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| EMC 5
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| No signature
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| Vol #:
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| 1
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| EMC
6
Attachment
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| American Bakers Assn (ABA)
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| Vol #:
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| 1
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| EMC 7
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| Jessica Rivera
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| Vol #:
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| 1
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| EMC 8
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| Michele Lougheed
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| Vol #:
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| 1
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| EMC 9
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| Lorin Lazer
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| Vol #:
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| 3
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| EMC 10
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| Kett
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| Vol #:
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| 1
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| EMC 11
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| Farinaz Farsai
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| Vol #:
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| 1
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| EMC 12
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| Donna Moens
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| Vol #:
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| 1
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| EMC 13
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| S. Wolff
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| Vol #:
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| 1
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| EMC 14
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| Liz Robbins
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| Vol #:
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| 1
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| EMC 15
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| Rachael M. Probst
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| Vol #:
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| 1
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| EMC 16
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| Robin Rogers
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| Vol #:
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| 1
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| EMC 17
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| David Rogers
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| Vol #:
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| 1
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| EMC 18
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| Frank Lauria
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| Vol #:
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| 1
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| EMC 19
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| Tom Kolarich
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| Vol #:
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| 1
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| EMC
20
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| Raconteur Productions
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| Vol #:
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| 1
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| EMC 21
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| Paul Knapp
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| Vol #:
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| 1
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| EMC 22
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| No signature
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| Vol #:
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| 1
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| EMC 23
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| Terri L. Jorgensen
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| Vol #:
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| 1
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| EMC 24
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| Cecily Dawson
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| Vol #:
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| 1
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| EMC 25
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| Lisa Whitman
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| Vol #:
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| 1
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| EMC 26
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| Darrin & Maureen Tannert
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| Vol #:
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| 1
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| EMC
27
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| EAMS Project
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| Vol #:
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| 1
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| EMC 28
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| Jill Morzillo
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| Vol #:
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| 1
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| EMC 29
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| No signature
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| Vol #:
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| 1
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| 2003N-0213
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| Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
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| N
2
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| FDA
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| Vol #:
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| 1
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| | | | | | | | |
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| |
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| 2003N-0286
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| Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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| N
2
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| FDA
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| Vol #:
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| 1
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|
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| 2003N-0324
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| Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing
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| LET
1
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| HFV-1 to Buchanan Ingersoll
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| Vol #:
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| 1
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| EMC 1
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| James P. Mock
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| Vol #:
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| 1
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| EMC 2
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| Melissa Porterfield
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| Vol #:
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| 1
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| EMC 3
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| Stephen Jordan
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| Vol #:
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| 1
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| EMC 4
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| Jose Luis Rocha
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| Vol #:
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| 1
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| EMC 5
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| Wes Francis
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| Vol #:
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| 1
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| EMC 6
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| David Irvine
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| Vol #:
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| 1
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| 2003N-0425
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| Agency Information Collection Activities: Proposed Collection; Comment Request
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0220
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| ANDA for Carboplatin, 10mg/mL, in strength of 600 mg/60 mL
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| PAV
1
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| HFD-600 to Faulding Pharmaceutical Company
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| Vol #:
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| 1
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| 2003P-0227
|
| ANDA Suitability Petition for Cefoxitin
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| PAV
1
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| HFD-600 to Samson Medical Technologies, LLC
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| Vol #:
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| 1
|
|
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| 2003P-0237
|
| ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg
|
|
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| PAV
1
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| HFD-600 to URL Mutual
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| Vol #:
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| 1
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|
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| 2003P-0274
|
| In re Tier 1 initial Approval Program
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| EMC 5
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| Mike Post
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| Vol #:
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| 1
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| EMC
6
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| National Organization for Rare Disorders, Inc. (NORD)
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| Vol #:
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| 1
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|
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| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
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| C 56
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| Dr. James R. Nickol
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| Vol #:
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| 1
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| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| RC
1
Attachment
1, 2, 3
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| ICN Pharmaceuticals, Inc. and Ribapharm Inc. (ICN/Ribapharm)
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| Vol #:
|
| 2
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|
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|
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| 2003P-0408
|
| Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets
|
|
|
|
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| C
1
|
| Synthon Pharmaceuticals, Ltd. (Synthon)
|
| Vol #:
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| 1
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