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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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|
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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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|
| | | | | | | |
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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| LET 20509
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| Perrigo Company of South Carolina
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| Vol #:
|
| 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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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
|
| 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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|
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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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|
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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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|
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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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|
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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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|
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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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|
| | | | | | | | |
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|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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
|
| Vol #:
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| 38
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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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| C 3230
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| T. Sparenborg
|
| Vol #:
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| 38
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|
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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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|
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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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|
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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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|
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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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|
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| C 3237
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| B. Caulfield
|
| Vol #:
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| 38
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|
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| C 3238
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| E. Capouano
|
| Vol #:
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| 38
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|
| | | | | | | |
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|
| C 3239
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| M. Cooley
|
| Vol #:
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| 38
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|
|
| C 3240
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| P. Eskow
|
| Vol #:
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| 38
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|
|
| C 3241
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| J. Roberts
|
| 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
|
| Vol #:
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| 38
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|
|
| C 3244
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| J. Son
|
| Vol #:
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| 38
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|
|
| C 3245
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| M. Murphy
|
| Vol #:
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| 38
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|
|
| C 3246
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| K. Cool
|
| Vol #:
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| 38
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|
|
| C 3247
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| D. M. Bombard
|
| Vol #:
|
| 38
|
|
|
| C 3248
|
| M. Bowen
|
| Vol #:
|
| 38
|
|
|
| C 3249
|
| O. V. Tetkowski
|
| Vol #:
|
| 38
|
|
|
| C 3250
|
| L. Greenawalt
|
| Vol #:
|
| 38
|
|
|
| C 3251
|
| G. Cool
|
| Vol #:
|
| 38
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|
|
| C 3252
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| R. Macdonlad
|
| Vol #:
|
| 38
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|
|
| C 3253
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| C. Kingery
|
| Vol #:
|
| 38
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|
|
| C 3254
|
| M. Adams
|
| Vol #:
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| 38
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|
|
| C 3255
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| L. Truitt
|
| Vol #:
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| 38
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|
|
| C 3256
|
| C. Barton
|
| Vol #:
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| 38
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|
|
| C 3257
|
| S. Porpora
|
| Vol #:
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| 38
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|
|
| C 3258
|
| M. Verhelle
|
| Vol #:
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| 38
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|
|
| C 3259
|
| M. Zaborek
|
| Vol #:
|
| 38
|
|
|
| C 3260
|
| C. Demartini
|
| Vol #:
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| 38
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|
|
| C 3261
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| R. Barbu
|
| Vol #:
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| 38
|
|
|
| C 3262
|
| S. M. Anderson
|
| Vol #:
|
| 38
|
|
|
| C 3263
|
| S. Warrow
|
| Vol #:
|
| 38
|
|
|
| C 3264
|
| G. Lennstrom
|
| Vol #:
|
| 38
|
|
|
| C 3265
|
| D. Evans
|
| Vol #:
|
| 38
|
|
|
| C 3266
|
| L. Mazer
|
| Vol #:
|
| 38
|
|
|
| C 3267
|
| R. Kay
|
| Vol #:
|
| 38
|
|
|
| C 3268
|
| J. Schwarz
|
| Vol #:
|
| 38
|
|
|
| C 3269
|
| N. Alvarez
|
| Vol #:
|
| 38
|
|
|
| C 3270
|
| S. Frye
|
| Vol #:
|
| 38
|
|
|
| C 3271
|
| D. Bryan
|
| Vol #:
|
| 38
|
|
|
| C 3272
|
| K. Storie
|
| Vol #:
|
| 38
|
|
|
| C 3273
|
| C. Perkins
|
| Vol #:
|
| 38
|
|
|
| C 3274
|
| J. Almli
|
| Vol #:
|
| 38
|
|
|
| C 3275
|
| M. Fanning
|
| Vol #:
|
| 38
|
|
| | | | | | | |
|
|
| C 3276
|
| K. Schrader
|
| Vol #:
|
| 38
|
|
|
| C 3277
|
| L. Frey
|
| Vol #:
|
| 38
|
|
|
| C 3278
|
| G. And L. Rose Blume
|
| Vol #:
|
| 38
|
|
|
| C 3279
|
| S. Reding
|
| Vol #:
|
| 38
|
|
|
| C 3280
|
| T. Mcfadden
|
| Vol #:
|
| 38
|
|
|
| C 3281
|
| S. Bodow
|
| Vol #:
|
| 38
|
|
|
| C 3282
|
| B. F. Lawton
|
| Vol #:
|
| 38
|
|
|
| C 3283
|
| A. Carrel
|
| Vol #:
|
| 38
|
|
|
| C 3284
|
| R. Linn
|
| Vol #:
|
| 38
|
|
|
| C 3285
|
| P. Pendley
|
| Vol #:
|
| 38
|
|
|
| C 3286
|
| A. Pennell
|
| Vol #:
|
| 38
|
|
|
| C 3287
|
| P. Prentice-best
|
| Vol #:
|
| 38
|
|
|
| C 3288
|
| T. Paquette
|
| Vol #:
|
| 38
|
|
|
| C 3289
|
| M. Benoit
|
| Vol #:
|
| 38
|
|
|
| C 3290
|
| W. E. Warsi
|
| Vol #:
|
| 38
|
|
|
| C 3291
|
| S. Millerman
|
| Vol #:
|
| 38
|
|
|
| C 3292
|
| K. Schmitt
|
| Vol #:
|
| 38
|
|
|
| C 3293
|
| A. Gasparre
|
| Vol #:
|
| 38
|
|
|
| C 3294
|
| D. Pawluczyk
|
| Vol #:
|
| 38
|
|
|
| C 3295
|
| C. Lefemine
|
| Vol #:
|
| 38
|
|
|
| C 3296
|
| J. Richter
|
| Vol #:
|
| 38
|
|
|
| C 3297
|
| P. Haardesty
|
| Vol #:
|
| 38
|
|
|
| C 3298
|
| L. Wilson
|
| Vol #:
|
| 38
|
|
|
| C 3299
|
| R. Benedict
|
| Vol #:
|
| 38
|
|
|
| C 3300
|
| M. J. Mcgee
|
| Vol #:
|
| 38
|
|
|
| C 3301
|
| B. Yuspa
|
| Vol #:
|
| 38
|
|
|
| C 3302
|
| K. Jurson
|
| Vol #:
|
| 38
|
|
|
| C 3303
|
| G. Picchetti
|
| Vol #:
|
| 38
|
|
|
| C 3304
|
| D. Hall
|
| Vol #:
|
| 38
|
|
|
| C 3305
|
| K. Hurschik
|
| Vol #:
|
| 38
|
|
|
| C 3306
|
| M. Barlow
|
| Vol #:
|
| 38
|
|
|
| C 3307
|
| J. O'brien
|
| Vol #:
|
| 38
|
|
|
| C 3308
|
| D. Ruvo
|
| Vol #:
|
| 39
|
|
|
| C 3309
|
| M. C. Reid
|
| Vol #:
|
| 39
|
|
|
| C 3310
|
| B. Boyle
|
| Vol #:
|
| 39
|
|
|
| C 3311
|
| M. Tabatcher
|
| Vol #:
|
| 38
|
|
|
| C 3312
|
| J. Biss
|
| Vol #:
|
| 39
|
|
| | | | | | | |
|
|
| C 3313
|
| J. M. Ferguson
|
| Vol #:
|
| 39
|
|
|
| C 3314
|
| C. Stallard
|
| Vol #:
|
| 39
|
|
|
| C 3315
|
| J. Schweizer
|
| Vol #:
|
| 39
|
|
|
| C 3316
|
| J. Treichel
|
| Vol #:
|
| 39
|
|
|
| C 3317
|
| D. Cera
|
| Vol #:
|
| 39
|
|
|
| C 3318
|
| J. E. Long
|
| Vol #:
|
| 39
|
|
|
| C 3319
|
| C. Cullen
|
| Vol #:
|
| 39
|
|
|
| C 3320
|
| M. Weaver
|
| Vol #:
|
| 39
|
|
|
| C 3321
|
| B. Eisenberg
|
| Vol #:
|
| 39
|
|
|
| C 3322
|
| S. Lennox
|
| Vol #:
|
| 39
|
|
|
| C 3323
|
| J. Lange
|
| Vol #:
|
| 39
|
|
|
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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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