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| Dockets Entered
On August 3, 2007
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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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-0272
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| ANDA Suitability for 0.9% Sodium Chloride Injection
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| 2006P-0273
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| ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| 2007N-0267
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| Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| 2007P-0307
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| To permit an ANDA Suitability for Hydrocodone Bitartrate and Homatropine Methylbromide Capsules 5 mg / 1.5 mg
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20465
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| PURE HEALTHY SCIENCES, LLC
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| Vol #:
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| 179
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| LET 20466
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| SILVERIO SALINAS INC.
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| Vol #:
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| 179
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| LET 20467
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| PuraPharm
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| Vol #:
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| 179
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| LET 20468
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| Ganeden Biotech Inc.
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| Vol #:
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| 179
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| LET 20469
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| DHC
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| Vol #:
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| 179
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| LET 20470
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| NATROL
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| Vol #:
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| 179
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| LET 20471
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| Wyeth Consumer Healthcare
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| Vol #:
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| 179
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| LET 20472
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20473
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20474
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20475
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20476
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20477
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20478
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20479
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20480
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20481
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20482
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20483
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20484
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20485
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20486
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20487
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20488
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20489
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20490
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20491
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20492
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20493
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20494
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20495
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20496
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| Enzmatic Therapy
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| Vol #:
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| 179
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| LET 20497
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| Metagenics
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| Vol #:
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| 179
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| LET 20498
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| Metagenics
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| Vol #:
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| 179
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| LET 20499
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| NUTRAGENESIS
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| Vol #:
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| 179
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| LET 20500
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| Source Naturals
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| Vol #:
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| 179
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| LET 20501
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| Ajinomoto USA, Inc.
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| Vol #:
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| 179
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| LET 20502
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| Ajinomoto USA, Inc.
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| Vol #:
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| 179
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| LET 20503
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| Ajinomoto USA, Inc.
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| Vol #:
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| 179
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| LET 20504
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| BiOTECH CORPORATION
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| Vol #:
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| 179
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| LET 20505
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| American Institute of Eastern Medicine
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| Vol #:
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| 179
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| LET 20506
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| World Nutrition
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| Vol #:
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| 179
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| LET 20507
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| NEUROSCIENCE
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| Vol #:
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| 179
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| LET 20508
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20509
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20510
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20511
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20512
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20513
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20514
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20515
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20516
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20517
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20518
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20519
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| Montana Vita Natural Health LLC
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| Vol #:
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| 179
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| LET 20520
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| Robert E. Armstrong
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| Vol #:
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| 179
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| LET 20521
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20522
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| Perrigo Company of South Carolina
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| Vol #:
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| 179
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| LET 20523
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| Randolph Gregg
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| Vol #:
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| 179
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| LET 20524
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| DHC
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| Vol #:
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| 179
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| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
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| C 3204
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| W. Motta
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| Vol #:
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| 38
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| C 3205
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| T. Metz
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| Vol #:
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| 38
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| C 3206
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| N. Bonilla
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| Vol #:
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| 38
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| C 3207
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| J. Ditton
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| Vol #:
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| 38
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| C 3208
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| L. Benigni
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| Vol #:
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| 38
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| C 3209
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| W. Soloman
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| Vol #:
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| 38
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| C 3210
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| M. Bottesch
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| Vol #:
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| 38
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| C 3211
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| M. W. Coleman
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| Vol #:
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| 38
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| C 3212
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| K. Bradford
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| Vol #:
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| 38
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| C 3213
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| E. M. Reid
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| Vol #:
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| 38
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| C 3214
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| G. Jones
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| Vol #:
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| 38
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| C 3215
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| S. Jaworski
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| Vol #:
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| 38
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| C 3216
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| D. M. Lugo
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| Vol #:
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| 38
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| C 3217
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| A. M. Adiletta
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| Vol #:
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| 38
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| C 3218
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| D. Gotthardt
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| Vol #:
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| 38
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| C 3219
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| P. Steedley
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| Vol #:
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| 38
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| C 3220
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| A. Ryan
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| Vol #:
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| 38
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| C 3221
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| J. Russo
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| Vol #:
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| 38
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| C 3222
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| O. Hernandez
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| Vol #:
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| 38
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| C 3223
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| M. Henry
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| Vol #:
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| 38
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| C 3224
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| T. Miller
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| Vol #:
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| 38
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| C 3225
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| C. Morris
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| Vol #:
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| 38
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| C 3226
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| R. M.
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| Vol #:
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| 38
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| C 3227
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| M. Pedersen
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| Vol #:
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| 38
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| C 3228
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| S. Hanlin
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| Vol #:
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| 38
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| C 3229
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| J. Hansen
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| Vol #:
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| 38
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| C 3230
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| T. Sparenborg
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| Vol #:
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| 38
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| C 3231
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| M. Simpson
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| Vol #:
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| 38
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| C 3232
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| J. Peck
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| Vol #:
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| 38
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| C 3233
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| P. A. Einbond
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| Vol #:
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| 38
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| C 3234
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| N. Abram
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| Vol #:
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| 38
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| C 3235
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| R. Legge
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| Vol #:
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| 38
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| C 3236
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| J. Zack
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| Vol #:
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| 38
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| C 3237
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| B. Caulfield
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| Vol #:
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| 38
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| C 3238
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| E. Capouano
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| Vol #:
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| 38
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| C 3239
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| M. Cooley
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| Vol #:
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| 38
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| C 3240
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| P. Eskow
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| Vol #:
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| 38
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| C 3241
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| J. Roberts
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| Vol #:
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| 38
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| C 3242
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| J. Erlanger
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| Vol #:
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| 38
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| C 3243
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| E. M. Conrad
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| Vol #:
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| 38
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| C 3244
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| J. Son
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| Vol #:
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| 38
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| C 3245
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| M. Murphy
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| Vol #:
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| 38
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| C 3246
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| K. Cool
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| Vol #:
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| 38
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| C 3247
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| D. M. Bombard
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| Vol #:
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| 38
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| C 3248
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| M. Bowen
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| Vol #:
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| 38
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| C 3249
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| O. V. Tetkowski
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| Vol #:
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| 38
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| C 3250
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| L. Greenawalt
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| Vol #:
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| 38
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| C 3251
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| G. Cool
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| Vol #:
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| 38
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| C 3252
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| R. Macdonlad
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| Vol #:
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| 38
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| C 3253
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| C. Kingery
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| Vol #:
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| 38
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| C 3254
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| M. Adams
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| Vol #:
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| 38
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| C 3255
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| L. Truitt
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| Vol #:
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| 38
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| C 3256
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| C. Barton
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| Vol #:
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| 38
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| C 3257
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| S. Porpora
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| Vol #:
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| 38
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| C 3258
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| M. Verhelle
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| Vol #:
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| 38
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| C 3259
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| M. Zaborek
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| Vol #:
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| 38
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| C 3260
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| C. Demartini
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| Vol #:
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| 38
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| C 3261
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| R. Barbu
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| Vol #:
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| 38
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| C 3262
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| S. M. Anderson
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| Vol #:
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| 38
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| C 3263
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| S. Warrow
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| Vol #:
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| 38
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| C 3264
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| G. Lennstrom
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| Vol #:
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| 38
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| C 3265
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| D. Evans
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| Vol #:
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| 38
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| |
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| C 3266
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| L. Mazer
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| Vol #:
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| 38
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| |
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| C 3267
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| R. Kay
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| Vol #:
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| 38
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| |
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| C 3268
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| J. Schwarz
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| Vol #:
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| 38
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| |
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| C 3269
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| N. Alvarez
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| Vol #:
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| 38
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| |
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| C 3270
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| S. Frye
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| Vol #:
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| 38
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| |
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| C 3271
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| D. Bryan
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| Vol #:
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| 38
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| |
|
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| C 3272
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| K. Storie
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| Vol #:
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| 38
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| |
|
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| C 3273
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| C. Perkins
|
| Vol #:
|
| 38
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| |
|
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| C 3274
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| J. Almli
|
| Vol #:
|
| 38
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| |
|
|
| C 3275
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| M. Fanning
|
| Vol #:
|
| 38
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|
| | | | | | | |
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| |
|
| C 3276
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| K. Schrader
|
| Vol #:
|
| 38
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| |
|
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| C 3277
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| L. Frey
|
| Vol #:
|
| 38
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| |
|
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| C 3278
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| G. And L. Rose Blume
|
| Vol #:
|
| 38
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| |
|
|
| C 3279
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| S. Reding
|
| Vol #:
|
| 38
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| |
|
|
| C 3280
|
| T. Mcfadden
|
| Vol #:
|
| 38
|
| |
|
|
| C 3281
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| S. Bodow
|
| Vol #:
|
| 38
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| |
|
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| C 3282
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| B. F. Lawton
|
| Vol #:
|
| 38
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| |
|
|
| C 3283
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| A. Carrel
|
| Vol #:
|
| 38
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| |
|
|
| C 3284
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| R. Linn
|
| Vol #:
|
| 38
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| |
|
|
| C 3285
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| P. Pendley
|
| Vol #:
|
| 38
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| |
|
|
| C 3286
|
| A. Pennell
|
| Vol #:
|
| 38
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| |
|
|
| C 3287
|
| P. Prentice-best
|
| Vol #:
|
| 38
|
| |
|
|
| C 3288
|
| T. Paquette
|
| Vol #:
|
| 38
|
| |
|
|
| C 3289
|
| M. Benoit
|
| Vol #:
|
| 38
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| |
|
|
| C 3290
|
| W. E. Warsi
|
| Vol #:
|
| 38
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| |
|
|
| C 3291
|
| S. Millerman
|
| Vol #:
|
| 38
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| |
|
|
| C 3292
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| K. Schmitt
|
| Vol #:
|
| 38
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| |
|
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| C 3293
|
| A. Gasparre
|
| Vol #:
|
| 38
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| |
|
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| C 3294
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| D. Pawluczyk
|
| Vol #:
|
| 38
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| |
|
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| C 3295
|
| C. Lefemine
|
| Vol #:
|
| 38
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| |
|
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| C 3296
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| J. Richter
|
| Vol #:
|
| 38
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| |
|
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| C 3297
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| P. Haardesty
|
| Vol #:
|
| 38
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| |
|
|
| C 3298
|
| L. Wilson
|
| Vol #:
|
| 38
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| |
|
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| C 3299
|
| R. Benedict
|
| Vol #:
|
| 38
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| |
|
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| C 3300
|
| M. J. Mcgee
|
| Vol #:
|
| 38
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| |
|
|
| C 3301
|
| B. Yuspa
|
| Vol #:
|
| 38
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| |
|
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| C 3302
|
| K. Jurson
|
| Vol #:
|
| 38
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| |
|
|
| C 3303
|
| G. Picchetti
|
| Vol #:
|
| 38
|
| |
|
|
| C 3304
|
| D. Hall
|
| Vol #:
|
| 38
|
| |
|
|
| C 3305
|
| K. Hurschik
|
| Vol #:
|
| 38
|
| |
|
|
| C 3306
|
| M. Barlow
|
| Vol #:
|
| 38
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| |
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| J. O'brien
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| Vol #:
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| 38
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| D. Ruvo
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| M. C. Reid
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| B. Boyle
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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