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| Dockets Entered
On April 4, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| 2004P-0490
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| Labeling of Anti-Fungal Drug Products
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| 2004P-0500
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| Meperidine Hydrochloirde Tablets in two strengths of 75 mg and 150 mg suitable for ANDA
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| 2004P-0560
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| ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg
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| 2004P-0561
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| ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005P-0007
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| ANDA Suitability for Risperidone Orally Disintegrating Tablets, 0.25 mg
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| 2005P-0066
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| ANDA Suitability for Amlodipine Besylate Capsules 2.5, 5, and 10mg
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| 2005R-0128
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| Proposal to Disqualify Charles M. Singleton, M.D.; Regulatory Hearing
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| EC
36
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| The Partnership for Anthrax Vaccine Education
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| Vol #:
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| 140
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| EC
37
Attachment
1, 2
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| The James Madison Project
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| Vol #:
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| 140
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| EC 38
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| Mr. Tom Heemstra
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| Vol #:
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| 140
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
813
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| HFS-800 to Corta-Flx, Inc
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| Vol #:
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| 25
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| LET
814
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| HFS-800 to Ashbury Biologicals Inc
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| Vol #:
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| 25
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| LET
815
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| HFS-800 to ZAND Herba Formulas, Botanical Laboratories Inc
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| Vol #:
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| 25
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| LET
816
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| HFS-800 to Tianshi Health Products Inc
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| Vol #:
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| 25
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| LET
817
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| HFS-800 to Nature's Way Products Inc
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| Vol #:
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| 25
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| LET
818
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| HFS-800 to Nutronix International
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| Vol #:
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| 25
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| LET
819
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| HFS-800 to CNS Inc
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| Vol #:
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| 25
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| LET
820
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| HFS-800 to Proliant Health Ingredients
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| Vol #:
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| 25
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| LET
821
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| HFS-800 to Source Naturals
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| Vol #:
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| 25
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| LET
822
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| HFS-800 to Natural Factors Nutritional Products Inc
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| Vol #:
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| 25
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 1126
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| Bayer Corporation
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| Vol #:
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| 469
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| NEC
1
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| FDA
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| Vol #:
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| 1
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| C
2
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| UPS Supply Chain Solutions Inc
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| Vol #:
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| 1
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| C
3
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| Canadian Food Inspection Agency
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| Vol #:
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| 1
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| BKG
2
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| Background Material
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| Vol #:
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| 7
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| BKG 3
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| Number not Used
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| Vol #:
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| 7
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| EA
2
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| HFD-7
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| Vol #:
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| 6
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| FONS
2
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| HFD-7
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| Vol #:
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| 6
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| NFR
1
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| FDA
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| Vol #:
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| 6
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| NAP
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| NAP
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| EREG 2
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| Vincins, Richard
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| Vol #:
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| 1
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| 2004P-0490
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| Labeling of Anti-Fungal Drug Products
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| PDN
1
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| HFC-1 to ProStrong Inc
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| Vol #:
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| 1
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| 2004P-0500
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| Meperidine Hydrochloirde Tablets in two strengths of 75 mg and 150 mg suitable for ANDA
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0560
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| ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0561
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| ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| EC
2
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| Weston A. Price Foundation
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| Vol #:
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| 6
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| EC 3
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| Mr. William Fontaine
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| Vol #:
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| 6
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| EC 4
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| Ms. Cheryl Ross
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| Vol #:
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| 6
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| EC 5
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| Mr. Stephen Bemis Esq.
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| Vol #:
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| 6
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| EC 6
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| Mrs. Claudia Wiens
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| Vol #:
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| 6
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| EC 7
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| Ms. Claudia Keel
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| Vol #:
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| 6
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| EC 8
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| Mrs. Monica Leibacher
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| Vol #:
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| 6
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| EC 9
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| Ms. Eowyn Levene
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| Vol #:
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| 6
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| EC 10
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| Mr. Anthony Roberts
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| Vol #:
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| 6
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| EC 11
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| Ms. Rita O'Kelley
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| Vol #:
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| 6
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| EC 12
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| Ms. Adrienne Hew
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| Vol #:
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| 6
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| EC 13
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| Ms. Arlene Beal
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| Vol #:
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| 6
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| EC 14
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| Mr. Dick Shaw
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| Vol #:
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| 6
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| EC 15
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| Mr. Vernon Essig
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| Vol #:
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| 6
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| EC 16
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| Mr. Charles Hubbell
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| Vol #:
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| 6
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| EC 17
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| Ms. Debbie Graham
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| Vol #:
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| 6
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| EC 18
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| Mr. KEVIN SCHMIDT
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| Vol #:
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| 6
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| EC 19
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| Mrs. Christine Banta
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| Vol #:
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| 6
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| EC 20
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| Dr. Margaret Dexter
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| Vol #:
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| 6
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| EC 21
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| Mr. Jonathan Sweet
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| Vol #:
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| 6
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| EC 22
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| Mrs. Nicole Killion, RN
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| Vol #:
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| 6
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0007
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| ANDA Suitability for Risperidone Orally Disintegrating Tablets, 0.25 mg
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0066
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| ANDA Suitability for Amlodipine Besylate Capsules 2.5, 5, and 10mg
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| SUP
2
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| Foley & Lardner LLP
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| Vol #:
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| 1
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| ACK
1
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| HFA-305 to Covington and Burling
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| Vol #:
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| 1
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| 2005R-0128
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| Proposal to Disqualify Charles M. Singleton, M.D.; Regulatory Hearing
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| SD
1
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| HF-3
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| Vol #:
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| 1
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