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| Dockets Entered
On July 13, 2007
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| Docket #
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| Title
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2006P-0393
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| Health Claim Petition: Barley Betafiber and Coronary Heart Disease
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0533
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| ANDA Suitability for Sterile Vancomycin Hydrochloride USP, 750 mg
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| 2006P-0534
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| ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| 2007D-0265
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| Global Harmonization Task Force, Study Groups 1, and 5; New Proposed and Final Documents
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| 2007D-0266
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| International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0215
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| Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0283
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| Take actions with respect to NDAs and ANDAs seeking approval of modified release oral dosage form drug products containing opioid active ingredients
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| 2007V-0281
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| Projector for a Laser Light Show
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 829
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 830
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 831
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 832
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 833
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 834
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 835
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| Mission Possible International
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| Vol #:
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| 11
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| EMC 836
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| Mission Possible International
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| Vol #:
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| 11
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| LET 5
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| Hill Dermaceuticals, Inc.
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| Vol #:
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| 1
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| C 1079
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| J. M. Foland
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| Vol #:
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| 16
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| C 1080
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| T. Peters
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| Vol #:
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| 16
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| EMC 100
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| Mission Possible International
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| Vol #:
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| 1
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| 2006P-0393
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| Health Claim Petition: Barley Betafiber and Coronary Heart Disease
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| EXT 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 106
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| C. Belcher
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| Vol #:
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| 7
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| 2006P-0533
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| ANDA Suitability for Sterile Vancomycin Hydrochloride USP, 750 mg
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| C 1
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| King & Spalding LLP
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| Vol #:
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| 1
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| 2006P-0534
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| ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
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| C 1
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| King & Spalding LLP
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| Vol #:
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| 1
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| C 7
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| V. Lee
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| Vol #:
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| 1
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| EC 3
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| GlaxoSmithKline
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| Vol #:
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| 0
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| EC 4
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| AstraZeneca LP
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| Vol #:
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| 0
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| EC 5
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| American Society of Health-System Pharmacists
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| Vol #:
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| 0
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| EC 6
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| Merck Research Laboratories
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| Vol #:
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| 0
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| EC 7
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| sanofi-aventis
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| Vol #:
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| 0
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| 2007D-0265
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| Global Harmonization Task Force, Study Groups 1, and 5; New Proposed and Final Documents
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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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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| GDL 3
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| Guidance
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| Vol #:
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| 1
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| GDL 4
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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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| 2007D-0266
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| International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
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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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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| C 4
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| International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
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| Vol #:
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| 7
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| C 5
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| National Council on Patient Information and Education (NCPIE)
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| Vol #:
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| 7
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| EC 19
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| Catalina Health Resource
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| Vol #:
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| 6
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| EC 20
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| University of Leeds
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| Vol #:
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| 6
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| EC 21
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| American Society of Health-System Pharmacists
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| Vol #:
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| 6
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| EC 22
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| United States Pharmacopeia
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| Vol #:
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| 6
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| EC 23
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| Virginia Pharmacists Association
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| Vol #:
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| 6
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| EC 24
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| Adheris, Inc.
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| Vol #:
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| 6
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| EC 25
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| American Pharmacists Association (APhA)
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| Vol #:
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| 6
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| EC 26
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| Pfizer Inc.
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| Vol #:
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| 6
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| TS 14
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| Representative Mike Ferguson (NJ-7)
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| Vol #:
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| 7
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| TS 15
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| J. Stoddard
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| Vol #:
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| 7
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| TS 16
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| J. Sisk
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| Vol #:
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| 7
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| TS 17
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| C. Watkins
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| Vol #:
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| 7
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| TS 18
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| Eli Lilly and Company
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| Vol #:
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| 7
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| TS 19
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| Pharmacists Planing Services, Inc (ppsi)
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| Vol #:
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| 7
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| 2007N-0215
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| Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
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| EC 1
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| Mrs. Donna Bolean
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| Vol #:
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| 1
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| EC 2
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| Dr. Jerome Tolbert
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| Vol #:
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| 1
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| EC 3
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| University of Colorado Health Sciences Center
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| Vol #:
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| 1
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| EC 4
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| The Endocrine Society
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| Vol #:
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| 1
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| EC 5
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| Cardiology Wellness Center, Nashville, TN
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| C 162
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| B. Brent
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| Vol #:
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| 6
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| C 163
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| L. Davis
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| Vol #:
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| 6
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| C 164
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| T. Battles
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| Vol #:
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| 6
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| C 165
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| W. Fairchild
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| Vol #:
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| 6
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| C 166
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| L. Driscoll
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| Vol #:
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| 6
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| C 167
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| M. Yinling
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| Vol #:
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| 6
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| C 168
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| A. Klingberg
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| Vol #:
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| 6
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| C 169
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| D. Zanoni
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| Vol #:
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| 6
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| C 170
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| S. Wike
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| Vol #:
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| 6
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| C 171
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| S. Morey
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| Vol #:
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| 6
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| C 172
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| S. Segal
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| Vol #:
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| 6
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| EC 1
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| Mr. Christopher Ryan
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| Vol #:
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| 1
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| 2007P-0282
|
| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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