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| Dockets Entered
On November 28, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2007D-0202
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| Guidance for Industry: Microbiological Considerations for
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| 2007D-0310
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| Companion to Guidance for Industry on Pharmacogenomic Data
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0432
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Soft-Ripened Cheese: Request for Comments and for Scientific Data and Information
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| 2007P-0175
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| ANADA Suitability for ivermectin/pyrantel pamoate chewable tablets
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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-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0345
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| Stay the effective date of any possible refusal of Entry AQZ-0250069-5 as consequence of the denial by Los Angeles District of the FD-766
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| 2007P-0404
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| Declare that Cefixime for Oral Suspension, 100 mg/mL, is suitable for submission as an ANDA
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| 1978N-0038
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| Sunscreen Drug Products
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| NEC 6
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| FDA
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| Vol #:
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| 170
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 21096
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| Heart of Health, Inc.
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| Vol #:
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| 182
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| LET 21097
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| Alaven Pharmaceuticals LLC
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| Vol #:
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| 182
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| LET 21098
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21099
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21100
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21101
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21102
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21103
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21104
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21105
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21106
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21107
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21108
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21109
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21110
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21111
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21112
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21113
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21114
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21115
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21116
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21117
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21118
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21119
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21120
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21121
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21122
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21123
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21124
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21125
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21126
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21127
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21128
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21129
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21130
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21131
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21132
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| LET 21133
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21134
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21135
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21136
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21137
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21138
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21139
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| Enzymatic Therapy
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| Vol #:
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| 182
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| LET 21140
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| Enzymatic Therapy
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| Vol #:
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| 182
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| EMC 12026
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| Sierra Club
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| Vol #:
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| 580
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| EC 8
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| Mrs. Robin Nelson
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| Vol #:
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| 1
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| C 7
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| Juice Products Association
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| Vol #:
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| 1
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| EC 101
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| Fresinius Medical Center
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| Vol #:
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| 1
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| EC 102
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| Union Hospital Diabetes Education Center
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| Vol #:
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| 1
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| EC 103
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| Ms. Meleah Montgomery
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| Vol #:
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| 1
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| 2007D-0202
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| Guidance for Industry: Microbiological Considerations for
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| EC 1
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| Food
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| Vol #:
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| 1
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| 2007D-0310
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| Companion to Guidance for Industry on Pharmacogenomic Data
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| C 5
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| Eli Lilly and Company
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| Vol #:
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| 1
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| EC 19
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| Veterinary Medical Informatics Laboratory
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| Vol #:
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| 2
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| EC 10
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| Mr. Robert Sussman
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| EC 74
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| American Association of Colleges of Pharmacy
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| Vol #:
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| 2
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| EC 75
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| Guttmacher Institute
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| Vol #:
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| 2
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| EC 76
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| Trinity Health
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| Vol #:
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| 2
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| EC 77
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| Mercy General Health Partners
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| Vol #:
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| 2
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| EC 78
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| Mr. Doug Cornelius
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| Vol #:
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| 2
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| EC 79
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| Three Rivers Health
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| Vol #:
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| 2
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| EC 80
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| MPA
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| Vol #:
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| 2
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| EC 81
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| Pattie Drug of Baldwin, Inc.
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| Vol #:
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| 2
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| EC 82
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| Westshore Health Network
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| Vol #:
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| 2
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| EC 83
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| Physician
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| Vol #:
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| 2
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| EC 84
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| Hellebusch Research
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| Vol #:
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| 2
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| EC 85
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| Valley Apothecary Inc
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| Vol #:
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| 2
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| EC 86
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| private citizen
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| Vol #:
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| 2
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| EC 87
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| member AAFP
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| Vol #:
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| 2
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| EC 88
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| Michigan Pharmacists Assoc.
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| Vol #:
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| 2
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| EC 89
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| Dr. Jane L Rogan
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| Vol #:
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| 2
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| EC 90
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| Mr. Derek Klemm
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| Vol #:
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| 2
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| EC 91
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| Ms. Catherine Bolger
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| Vol #:
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| 2
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| EC 92
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| Massachusetts Academy of Family Physicians
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| Vol #:
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| 2
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| EC 93
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| Mrs. Carol LeCureaux, Pharm.D
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| Vol #:
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| 2
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| EC 94
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| Ms. Beth Freeman
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| Vol #:
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| 2
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| EC 95
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| Ms. Melissa Keller
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| Vol #:
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| 2
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| EC 96
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| Mrs. Elaine Shelton
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| Vol #:
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| 2
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| EC 97
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| UCLA School of Medicine
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| Vol #:
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| 2
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| EC 98
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| Dr. Kenneth Ukauwa
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| Vol #:
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| 2
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| EC 99
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| Dr. Jason McCauley
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| Vol #:
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| 2
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| EC 100
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| University of Pittsburgh
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| Vol #:
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| 2
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| EC 101
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| Dr. Lynne Zucker
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| Vol #:
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| 2
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| EC 102
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| Mrs. Robin Neudorfer
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| Vol #:
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| 2
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| EC 103
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| Dr. Peter Marsh
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| Vol #:
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| 2
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| 2007N-0432
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Soft-Ripened Cheese: Request for Comments and for Scientific Data and Information
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|
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| NRD 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0175
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| ANADA Suitability for ivermectin/pyrantel pamoate chewable tablets
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| LET 1
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| Steven D. Vaughn
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| Vol #:
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| 1
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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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| EC 72
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| BE
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| Vol #:
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| 1
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| EC 140
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| Ms. Joanne Jensen
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| Vol #:
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| 1
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| 2007P-0345
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| Stay the effective date of any possible refusal of Entry AQZ-0250069-5 as consequence of the denial by Los Angeles District of the FD-766
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| LET 1
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| Glenn Harrison
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| Vol #:
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| 1
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| 2007P-0404
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| Declare that Cefixime for Oral Suspension, 100 mg/mL, is suitable for submission as an ANDA
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2007P-0438
|
| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
|
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| |
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| EC 7
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| Ms. Angel De Fazio
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| Vol #:
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| 3
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| EC 8
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| Mrs. Gisela Mueller
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| Vol #:
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| 3
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