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| Dockets Entered
On September 11, 2006
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| |
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| 2004E-0425
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| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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| |
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006E-0008
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| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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| |
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| 2006E-0204
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| Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0372
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| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006V-0373
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| Laser Light Show
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 344
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| JLM Marketing Inc
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| Vol #:
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| 270
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| RPT 345
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| JLM Marketing Inc
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| Vol #:
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| 270
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| RPT 346
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| pH Sciences
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| Vol #:
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| 270
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| RPT 347
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| Health World, Inc
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| Vol #:
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| 270
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| RPT 348
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| Kaneka Corporation
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| Vol #:
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| 271
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| RPT 349
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| Pom Wonderful LLC
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| Vol #:
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| 270
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| RPT 350
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| Piscium International
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| Vol #:
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| 270
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| RPT 351
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| Seppie Inc
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| Vol #:
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| 270
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| RPT 352
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| Seppie Inc
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| Vol #:
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| 270
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| RPT 353
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| Seppie Inc
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| Vol #:
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| 270
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| SUP 16
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| Global Cancer Strategies
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| Vol #:
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| 270
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18100
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18101
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18102
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| Nutrition Now Inc
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| Vol #:
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| 167
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| |
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| LET 18103
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| Flora Inc
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| Vol #:
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| 167
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| |
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| LET 18104
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| PuraPharm Corporation
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| Vol #:
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| 167
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| LET 18105
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| PuraPharm Corporation
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| Vol #:
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| 167
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| |
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| LET 18106
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| New Century Company
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| Vol #:
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| 167
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| LET 18107
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| LET 18108
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| LET 18109
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| LET 18110
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| LET 18111
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| LET 18112
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18113
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18114
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18115
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| LET 18116
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18117
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18118
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18119
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18120
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18121
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| Integrative Therapeutics Inc
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| Vol #:
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| 167
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| LET 18122
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| InteMedica LLC
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| Vol #:
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| 167
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| |
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| LET 18123
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| Lapte Enterprises, Inc dba Fruit Advantage
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| Vol #:
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| 167
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| LET 18124
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| Lapte Enterprises, Inc dba Fruit Advantage
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| Vol #:
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| 167
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| |
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| LET 18125
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| Lapte Enterprises, Inc dba Fruit Advantage
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| Vol #:
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| 167
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| |
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| LET 18126
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| Lipid Nutrition
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| Vol #:
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| 167
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| LET 18127
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| ECONET Inc dba Oasis LifeSciences
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| Vol #:
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| 167
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| LET 18128
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| Natural Factors Nutritional Products Inc
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| Vol #:
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| 167
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| |
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| LET 18129
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| Natural Factors Nutritional Products Inc
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| Vol #:
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| 167
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| |
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|
| LET 18130
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| Natural Factors Nutritional Products Inc
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| Vol #:
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| 167
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| |
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| LET 18131
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| Natural Factors Nutritional Products Inc
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| Vol #:
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| 167
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| |
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| LET 18132
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| Natural Factors Nutritional Products Inc
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| Vol #:
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| 167
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| |
|
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| LET 18133
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| Natural Factors Nutritional Products Inc
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| Vol #:
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| 167
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| |
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| LET 18134
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18135
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18136
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| Pharmavite LLC
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| Vol #:
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| 167
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| |
|
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| LET 18137
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| Perrigo Company of South Carolina
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| Vol #:
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| 167
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| |
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| LET 18138
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| JOL Management
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| Vol #:
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| 167
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| |
|
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| LET 18139
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| Nutriex LC
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| Vol #:
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| 167
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| |
|
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| LET 18140
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| Nutrition Now Inc
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| Vol #:
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| 167
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|
| |
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| |
|
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| EC 31
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| Mrs. JANET RITTER
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| Vol #:
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| 5
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|
| | | | | | | | |
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| 2004E-0425
|
| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2004E-0427
|
| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
| |
|
| 2005D-0195
|
| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
|
| |
|
|
| EC 8
|
| New York University-School of Medicine
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| Vol #:
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| 1
|
| |
|
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| 2005E-0253
|
| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
| |
|
|
| EC 2
|
| Ms. Debra Jo Endres-Ard
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| Vol #:
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| 1
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| |
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| EC 3
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| La Cesta Consultants, LLC
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| Vol #:
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| 1
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| |
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| EC 4
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| Citizen of The United States
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| Vol #:
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| 1
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| EC 5
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| R Adams Cowley Shock Trauma Center
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| Vol #:
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| 1
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| |
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| EC 6
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| Ms. Elaine Daly
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| Vol #:
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| 1
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| |
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| EC 7
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| Boston Universtity School of Medicine
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| Vol #:
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| 1
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| |
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| EC 8
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| Ms. Debra Jo Endres-Ard
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| Vol #:
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| 1
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| |
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| EC 9
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| Wisconsin State EMS Medical Director
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| Vol #:
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| 1
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| |
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| EC 10
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| Ms. Elaine Daly
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| Vol #:
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| 1
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| |
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| EC 11
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| Citizen
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| Vol #:
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| 1
|
| |
|
|
| 2006E-0008
|
| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2006E-0031
|
| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
|
| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2006E-0050
|
| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
| |
|
| 2006E-0204
|
| Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
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| |
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| EC 591
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| Dr. Juan Hernandez MD
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| Vol #:
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| 5
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| |
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| EC 592
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| Mr. Justin Wassel
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| Vol #:
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| 5
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|
| | | | | | | |
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| |
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| EC 593
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| Mr. Richard Cox
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| Vol #:
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| 5
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| |
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| EC 594
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| Mr. Michael Blaine
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| Vol #:
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| 5
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| |
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| EC 595
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| Mr. Michael Bredeweg
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| Vol #:
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| 5
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| |
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| EC 596
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| Mrs. Barbara Rebentisch
|
| Vol #:
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| 5
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| |
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| EC 597
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| RN
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| Vol #:
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| 5
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| |
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| EC 598
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| Mrs. Julie Hering
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| Vol #:
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| 5
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| |
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| EC 599
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| Mr. Tucker Wilson
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| Vol #:
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| 5
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| |
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| EC 600
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| Mr. Harold Hughes
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| Vol #:
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| 5
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| |
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| EC 601
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| church of Christ
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| Vol #:
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| 5
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| |
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| EC 602
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| Mr. Bruce Dougherty
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| Vol #:
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| 5
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| |
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| EC 603
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| Ms. Joy Williams
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| Vol #:
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| 5
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| |
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| EC 604
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| Mrs. Kathleen Elsie Gibbs
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| Vol #:
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| 5
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| |
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| EC 605
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| Mrs. Anita Becker
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| Vol #:
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| 5
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| |
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| EC 606
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| KJB Investments
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| Vol #:
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| 5
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| |
|
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| EC 607
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| Mr. Johnny Lamb
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| Vol #:
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| 5
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| |
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| EC 608
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| Mrs. Dawne McGrath
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| Vol #:
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| 5
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| |
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| EC 609
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| Miss. Monica Baird
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| Vol #:
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| 5
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| |
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| EC 610
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| Mrs. Drucilla White
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| Vol #:
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| 5
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| |
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| EC 611
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| Mr. Michael Ciha
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| Vol #:
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| 5
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| |
|
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| EC 612
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| Mr. Thomas Olsen
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| Vol #:
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| 5
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| |
|
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| EC 613
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| Mr. Kenneth Earl
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| Vol #:
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| 5
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| |
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| EC 614
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| Ms. Nancy Vicalvi
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| Vol #:
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| 5
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| |
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| EC 615
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| Sptoswood Right to Life
|
| Vol #:
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| 5
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| |
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| EC 616
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| Mr. Arnold Joubert
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| Vol #:
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| 5
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| |
|
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| EC 617
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| N/A
|
| Vol #:
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| 5
|
| |
|
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| EC 618
|
| Mr. Earl Takes
|
| Vol #:
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| 5
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| |
|
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| EC 619
|
| Mr. Thomas Nosacek
|
| Vol #:
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| 5
|
| |
|
|
| EC 620
|
| Mrs. carol hadzicki
|
| Vol #:
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| 5
|
| |
|
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| EC 621
|
| Mrs. Carolyn Voegtlin
|
| Vol #:
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| 5
|
| |
|
|
| EC 622
|
| Mrs. Carla Sherman
|
| Vol #:
|
| 5
|
| |
|
|
| EC 623
|
| Mrs. Lydia Archer
|
| Vol #:
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| 5
|
| |
|
|
| EC 624
|
| Retired R.N.
|
| Vol #:
|
| 5
|
| |
|
|
| EC 625
|
| Mr. Maurice Kienenberger
|
| Vol #:
|
| 5
|
| |
|
|
| EC 626
|
| Ms. Angela Webb
|
| Vol #:
|
| 5
|
| |
|
|
| EC 627
|
| Dr. Murray Brown
|
| Vol #:
|
| 5
|
| |
|
|
| EC 628
|
| Mrs. Grace Harman
|
| Vol #:
|
| 5
|
| |
|
|
| EC 629
|
| Mrs. Carolyn Kapp
|
| Vol #:
|
| 5
|
|
| | | | | | | |
|
| |
|
| EC 630
|
| Health South
|
| Vol #:
|
| 5
|
| |
|
|
| EC 631
|
| Mr. Ben Nation
|
| Vol #:
|
| 5
|
| |
|
|
| EC 632
|
| Mr. Daniel Fowler
|
| Vol #:
|
| 5
|
| |
|
|
| EC 633
|
| none
|
| Vol #:
|
| 5
|
| |
|
|
| EC 634
|
| Mrs. Lisa Metzen
|
| Vol #:
|
| 5
|
| |
|
|
| EC 635
|
| Ms. Joan Hollman
|
| Vol #:
|
| 5
|
| |
|
|
| EC 636
|
| Mrs. Clarissa Bohrer
|
| Vol #:
|
| 5
|
| |
|
|
| EC 637
|
| Mrs. Jennifer Junio
|
| Vol #:
|
| 5
|
| |
|
|
| EC 638
|
| Mr. Jeff Glenn
|
| Vol #:
|
| 5
|
| |
|
|
| EC 639
|
| Ms. Fran Wilson
|
| Vol #:
|
| 5
|
| |
|
|
| EC 640
|
| Mr. Aldon Schaap
|
| Vol #:
|
| 5
|
| |
|
|
| EC 641
|
| Mrs. Annette Johnsen
|
| Vol #:
|
| 5
|
| |
|
|
| EC 642
|
| none
|
| Vol #:
|
| 5
|
| |
|
|
| EC 643
|
| Mrs. Louise Williams
|
| Vol #:
|
| 5
|
| |
|
|
| EC 644
|
| Mr. Paul Mossey
|
| Vol #:
|
| 5
|
| |
|
|
| EC 645
|
| Mr. Guy Stephenson
|
| Vol #:
|
| 5
|
| |
|
|
| EC 646
|
| Mrs. Geraldine Duzenack
|
| Vol #:
|
| 5
|
| |
|
|
| EC 647
|
| Mrs. Grace Hefflinger
|
| Vol #:
|
| 5
|
| |
|
|
| EC 648
|
| Mr. Allen Lakner
|
| Vol #:
|
| 5
|
| |
|
|
| EC 649
|
| Mrs. Dawn Speer
|
| Vol #:
|
| 5
|
| |
|
|
| EC 650
|
| Mrs. Grace Hefflinger
|
| Vol #:
|
| 5
|
| |
|
|
| EC 651
|
| Citizen
|
| Vol #:
|
| 5
|
| |
|
|
| EC 652
|
| N/A
|
| Vol #:
|
| 5
|
| |
|
|
| EC 653
|
| Dr. Peter Redburn
|
| Vol #:
|
| 5
|
| |
|
|
| EC 654
|
| Miss. John McNamara
|
| Vol #:
|
| 5
|
| |
|
|
| EC 655
|
| Miss. Elena Hung
|
| Vol #:
|
| 5
|
| |
|
|
| EC 656
|
| Grassfire.orgalliance
|
| Vol #:
|
| 5
|
| |
|
|
| EC 657
|
| n/a
|
| Vol #:
|
| 5
|
| |
|
|
| EC 658
|
| Mr. David Paul Xavier Burch
|
| Vol #:
|
| 5
|
| |
|
|
| EC 659
|
| none
|
| Vol #:
|
| 5
|
| |
|
|
| EC 660
|
| NA
|
| Vol #:
|
| 5
|
| |
|
|
| EC 661
|
| Mrs. Jeri B. Miller
|
| Vol #:
|
| 5
|
| |
|
|
| EC 662
|
| Mrs. Danita Scheid
|
| Vol #:
|
| 5
|
| |
|
|
| EC 663
|
| Mrs. Nancy Martinez
|
| Vol #:
|
| 5
|
| |
|
|
| EC 664
|
| Mrs. Bonnie Holt
|
| Vol #:
|
| 5
|
| |
|
|
| EC 665
|
| Mrs. nicki wharton
|
| Vol #:
|
| 5
|
| |
|
|
| EC 666
|
| Mr. Kenneth LeRoy
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
|
| |
|
| EC 667
|
| Mrs. Patricia Burton
|
| Vol #:
|
| 5
|
| |
|
|
| EC 668
|
| Dr. muhhamad waseem
|
| Vol #:
|
| 5
|
| |
|
|
| EC 669
|
| Mr. Alan Haggard
|
| Vol #:
|
| 5
|
| |
|
|
| EC 670
|
| Mrs. Annette Unger
|
| Vol #:
|
| 5
|
| |
|
|
| EC 671
|
| Mrs. kathleen oakley
|
| Vol #:
|
| 5
|
| |
|
|
| EC 672
|
| Ms. Pauline Anderberg
|
| Vol #:
|
| 5
|
| |
|
|
| EC 673
|
| Ms. Patricia Staege
|
| Vol #:
|
| 5
|
| |
|
|
| EC 674
|
| Miss. Jessica Hoffman
|
| Vol #:
|
| 5
|
| |
|
|
| EC 675
|
| Dr. Judith Edwards
|
| Vol #:
|
| 5
|
| |
|
|
| EC 676
|
| Ms. Eileen Ratigan
|
| Vol #:
|
| 5
|
| |
|
|
| EC 677
|
| Ms. Dagmar Hoffmann
|
| Vol #:
|
| 5
|
| |
|
|
| EC 678
|
| REGISTERED NURSE
|
| Vol #:
|
| 5
|
| |
|
|
| EC 679
|
| Mr. Duane Oelrich
|
| Vol #:
|
| 5
|
| |
|
|
| EC 680
|
| Mrs. Michelle Winder
|
| Vol #:
|
| 5
|
| |
|
|
| EC 681
|
| Mr. Mark McAdow
|
| Vol #:
|
| 5
|
| |
|
|
| EC 682
|
| Mr. Greg Schneider
|
| Vol #:
|
| 5
|
| |
|
|
| EC 683
|
| Mrs. Helen Nixon
|
| Vol #:
|
| 5
|
| |
|
|
| EC 684
|
| Mrs. Marie Barney
|
| Vol #:
|
| 5
|
|
| |
|
| 2006P-0372
|
| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| ACK 1
|
| FDA/DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006V-0373
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA /DDM to Griffith Observatory, (Oschin Planetarium)
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Griffith Observatory, (Oschin Planetarium)
|
| Vol #:
|
| 1
|
|
|
