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| Dockets Entered
On May 24, 2006
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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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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Applications and Related Submissions
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| 2003E-0250
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| Patent Extension for Invanz (ertapenem sodium), 5,478,820
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| 2003E-0254
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| Patent Extension for Inspra (eplerenone), 4,559,332
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| 2004E-0011
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| Patenet Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)
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| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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| 2004E-0413
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| Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0428
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| Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requ
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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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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| 2006E-0026
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| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| 2006E-0040
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| Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| 2006P-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| 2006P-0218
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| To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17689
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17690
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17691
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17692
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17693
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17694
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17695
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17696
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17697
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17698
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17699
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17700
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| | | | | | | |
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| LET 17701
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17702
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17703
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17704
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| Ortho Molecular Products Inc.
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| Vol #:
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| 163
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| LET 17705
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17706
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17707
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17708
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17709
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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| LET 17710
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17711
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17712
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17713
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17714
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17715
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17716
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17717
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17718
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17719
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17720
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17721
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17722
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17723
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17724
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17725
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17726
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17727
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17728
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17729
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17730
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17731
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17732
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17733
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17734
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17735
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17736
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 163
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|
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| LET 17737
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| Pharmavite LLC
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| Vol #:
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| 163
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| | | | | | | | |
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|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
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|
|
| EC 32
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| Flavor and Extract Manufacturers Association
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| Vol #:
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| 1
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|
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| EC 33
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| Ms. Catherine Tretheway
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| Vol #:
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| 1
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|
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| EC 34
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| International Association of Color Manufacturers
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| Vol #:
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| 1
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| EC 35
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| International Dairy Foods Association
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| Vol #:
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| 1
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|
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| EC 36
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| Mary Kay Inc.
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| Vol #:
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| 1
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|
|
| 2003D-0367
|
| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Applications and Related Submissions
|
|
|
| EC 3
|
| Mr. Mark ONeill
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| Vol #:
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| 1
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|
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| EC 4
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| Mr. MARK ONEILL
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| Vol #:
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| 1
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|
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| 2003E-0250
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| Patent Extension for Invanz (ertapenem sodium), 5,478,820
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|
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| LET 5
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
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| 2003E-0254
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| Patent Extension for Inspra (eplerenone), 4,559,332
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|
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| LET 3
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
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| 2004E-0011
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| Patenet Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)
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| LET 3
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
|
| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
|
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
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| 1
|
|
|
| 2004E-0413
|
| Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006
|
|
|
| LET 4
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2004E-0444
|
| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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|
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| LET 3
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| HFD-005 to tU.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
|
| 2005D-0011
|
| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
|
|
|
| EC 1
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| Mr. Barrett Lundgren
|
| Vol #:
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| 2
|
|
|
| EC 2
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| Pharm Res
|
| Vol #:
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| 2
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|
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| EC 3
|
| GlaxoSmithKline
|
| Vol #:
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| 2
|
|
|
| 2005D-0490
|
| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
|
|
| EC 18
|
| Mrs. Paula Turner
|
| Vol #:
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| 1
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
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|
|
| CS 11
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| FDA/DDM
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| Vol #:
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| 3
|
|
|
| OR 11
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| HF-3 to TMJ Implants and Robert W. Christensen and Maureen K. Mooney
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| Vol #:
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| 3
|
|
| | | | | | | | |
|
|
| 2005N-0428
|
| Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requ
|
|
|
|
|
|
| EC 1
|
| BloodCenter of Wisconsin, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| The Hemophilia Alliance
|
| Vol #:
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| 1
|
|
|
| EC 3
|
| Americas Blood Centers
|
| Vol #:
|
| 1
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 10249
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| E. A. Moore
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| Vol #:
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| 140
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|
|
| C 10250
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| J. C. Spraggan
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| Vol #:
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| 140
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|
|
| C 10251
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| A. M. Eklune
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| Vol #:
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| 140
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|
|
| C 10252
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| L. Hamliton
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| Vol #:
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| 140
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|
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| C 10253
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| C. Ban
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| Vol #:
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| 140
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|
|
| C 10254
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| M. S. Dinn
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| Vol #:
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| 140
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|
|
| C 10255
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| C. E. Tiddurll
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| Vol #:
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| 140
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|
|
| C 10256
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| M. S. Darga
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| Vol #:
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| 140
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|
|
| C 10257
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| R. L. Duncan
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| Vol #:
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| 140
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|
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| C 10258
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| B. Chessor
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| Vol #:
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| 140
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|
|
| C 10259
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| M, Greiner
|
| Vol #:
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| 140
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|
|
| C 10260
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| C. Middleton
|
| Vol #:
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| 140
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|
|
| C 10261
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| I. Marie
|
| Vol #:
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| 140
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|
|
| C 10262
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| E. J. Hartley
|
| Vol #:
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| 140
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|
|
| C 10263
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| J. Hodges
|
| Vol #:
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| 140
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|
|
| C 10264
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| K. McEntee
|
| Vol #:
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| 140
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|
|
| C 10265
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| A. Laker
|
| Vol #:
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| 140
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|
|
| C 10266
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| E. J. Hartley
|
| Vol #:
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| 140
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|
|
| C 10267
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| W. Ulve
|
| Vol #:
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| 140
|
|
|
| C 10268
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| L. F. Partridge
|
| Vol #:
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| 140
|
|
|
| C 10269
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| A. M. Davis
|
| Vol #:
|
| 140
|
|
|
| C 10270
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| J. Ehrhardt
|
| Vol #:
|
| 140
|
|
|
| C 10271
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| D. Basso
|
| Vol #:
|
| 140
|
|
|
| C 10272
|
| F. Krasowsky
|
| Vol #:
|
| 140
|
|
|
| C 10273
|
| I. Jones
|
| Vol #:
|
| 140
|
|
|
| C 10274
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| S. Chander
|
| Vol #:
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| 140
|
|
|
| C 10275
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| C. Femia
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| Vol #:
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| 140
|
|
|
| C 10276
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| R. Femia
|
| Vol #:
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| 140
|
|
|
| C 10277
|
| L. Clayton
|
| Vol #:
|
| 140
|
|
|
| C 10278
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| P. Caughell
|
| Vol #:
|
| 140
|
|
| | | | | | | |
|
|
| C 10279
|
| P. Boyer
|
| Vol #:
|
| 140
|
|
|
| C 10280
|
| J. Mandel
|
| Vol #:
|
| 140
|
|
|
| C 10281
|
| E. Leonard
|
| Vol #:
|
| 140
|
|
|
| C 10282
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| M. Dailey
|
| Vol #:
|
| 140
|
|
|
| C 10283
|
| A. Pfalzer
|
| Vol #:
|
| 140
|
|
|
| C 10284
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| L. Moeser
|
| Vol #:
|
| 140
|
|
|
| C 10285
|
| S. breeden
|
| Vol #:
|
| 140
|
|
|
| C 10286
|
| J. Bayer
|
| Vol #:
|
| 140
|
|
|
| C 10287
|
| A. Dettmer
|
| Vol #:
|
| 140
|
|
|
| C 10288
|
| T. Anthong
|
| Vol #:
|
| 140
|
|
|
| C 10289
|
| J. Tucker
|
| Vol #:
|
| 140
|
|
|
| C 10290
|
| J. Tucker
|
| Vol #:
|
| 140
|
|
|
| C 10291
|
| J. M. Harrision
|
| Vol #:
|
| 140
|
|
|
| C 10292
|
| J. Price
|
| Vol #:
|
| 140
|
|
|
| C 10293
|
| T. Dahl
|
| Vol #:
|
| 140
|
|
|
| C 10294
|
| E. R.Colwell
|
| Vol #:
|
| 140
|
|
|
| C 10295
|
| M. Hines
|
| Vol #:
|
| 140
|
|
|
| C 10296
|
| B. L. Moss
|
| Vol #:
|
| 140
|
|
|
| C 10297
|
| L. Schwaab
|
| Vol #:
|
| 140
|
|
|
| C 10298
|
| A. D. Sutton
|
| Vol #:
|
| 140
|
|
|
| C 10299
|
| J. Price
|
| Vol #:
|
| 140
|
|
|
| C 10300
|
| P. Dickinson
|
| Vol #:
|
| 140
|
|
|
| C 10301
|
| A. Cowling
|
| Vol #:
|
| 140
|
|
|
| C 10302
|
| D. Harris
|
| Vol #:
|
| 140
|
|
|
| C 10303
|
| D. Sorey
|
| Vol #:
|
| 140
|
|
|
| C 10304
|
| N. Summers
|
| Vol #:
|
| 140
|
|
|
| C 10305
|
| D. I Marchetti
|
| Vol #:
|
| 140
|
|
|
| C 10306
|
| M. Hopkins
|
| Vol #:
|
| 140
|
|
|
| C 10307
|
| L. Elliott
|
| Vol #:
|
| 140
|
|
|
| C 10308
|
| L. A. LaFlure
|
| Vol #:
|
| 140
|
|
|
| C 10309
|
| A. Endris
|
| Vol #:
|
| 140
|
|
|
| C 10310
|
| G. K. McGill
|
| Vol #:
|
| 140
|
|
|
| C 10311
|
| O. Jones
|
| Vol #:
|
| 140
|
|
|
| C 10312
|
| D. Slimp
|
| Vol #:
|
| 140
|
|
|
| C 10313
|
| J. Delbianco
|
| Vol #:
|
| 140
|
|
|
| C 10314
|
| A. D. Julius, MD
|
| Vol #:
|
| 140
|
|
|
| C 10315
|
| P. Pews
|
| Vol #:
|
| 140
|
|
| | | | | | | |
|
|
| C 10316
|
| A. Kowlowski
|
| Vol #:
|
| 140
|
|
|
| C 10317
|
| D. Tyler
|
| Vol #:
|
| 140
|
|
|
| C 10318
|
| B. Cavallo
|
| Vol #:
|
| 140
|
|
|
| C 10319
|
| J. A. Carluccus
|
| Vol #:
|
| 140
|
|
|
| C 10320
|
| W. Fletcher
|
| Vol #:
|
| 140
|
|
|
| C 10321
|
| D. Boldevi
|
| Vol #:
|
| 140
|
|
|
| C 10322
|
| G. Siber
|
| Vol #:
|
| 140
|
|
|
| C 10323
|
| K. Hughes
|
| Vol #:
|
| 140
|
|
|
| C 10324
|
| L. Cories
|
| Vol #:
|
| 140
|
|
|
| C 10325
|
| K. Marden
|
| Vol #:
|
| 140
|
|
|
| C 10326
|
| S. Perryman
|
| Vol #:
|
| 140
|
|
|
| C 10327
|
| L. Batie
|
| Vol #:
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| 140
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| C 10328
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| T. Harrson, MD
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| 140
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| C 10329
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| G. DeHart
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| 140
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| C 10330
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| B. Swenson
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| 140
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| C 10331
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| J. E. Sern
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| Vol #:
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| 140
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| C 10332
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| S. Thornton
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| 140
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| C 10333
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| K. Dunker
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| 140
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| C 10334
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| F. Goldston
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| Vol #:
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| 140
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| C 10335
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| S..A. Bunn
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| Vol #:
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| 140
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| C 10336
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| C. Davis
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| Vol #:
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| 140
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| C 10337
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| S. McCleery
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| C 10338
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| L. Funston
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| Vol #:
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| C 10339
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| L. Funston
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| Vol #:
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| 140
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| C 10340
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| S. Bock
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| Vol #:
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| 140
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| C 10341
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| S. West
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| 140
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| C 10342
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| M. V. Hicks
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| Vol #:
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| 140
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| C 10343
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| E. Kozar
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| Vol #:
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| 140
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| C 10344
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| S. Hickey
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| Vol #:
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| 140
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| C 10345
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| A. Palmer
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| 140
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| C 10346
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| M. V. Pette
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| 140
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| C 10347
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| L. Fuchs
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| 140
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| C 10348
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| L. Fuchs
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| 140
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| C 10349
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| A. Phillips
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| 140
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| C 10350
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| P. E. Thielman
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| 140
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| C 10351
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| B. Renzelman
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| 140
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| C 10352
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| D. Watts
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| Vol #:
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| 140
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| C 10353
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| M. Micheau
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| 140
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| L. Monianty
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| C. Huard
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| L. Adams
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| C 10357
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| U. Braun
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| Vol #:
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| 140
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| Unreadable
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| 140
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| C 10359
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| M. Dunker
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| Vol #:
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| 140
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| M. Dunker
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| Vol #:
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| E. Karat
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| Vol #:
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| L. Card
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| P. J. Rook
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| Vol #:
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| L. Berry
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| S. Durkee
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| S. L. Franks
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| Vol #:
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| M. Kelley
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| J. Nicklin
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| Vol #:
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| L. Blackwell
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| Vol #:
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| 140
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| C. M. Solton
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| Vol #:
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| S. M. Roming
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| Vol #:
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| V. Hudson
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| D. Caron
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| L. Todryk
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| Vol #:
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| R. Shaw
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| C. Hassell
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| S Minkoff
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| L. Carroll
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| Vol #:
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| 140
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| S. J. Lauber
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| Vol #:
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| 140
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| C 10380
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| R. Ballmer
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| Vol #:
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| 140
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| C 10381
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| A. Sughroue
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| Vol #:
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| 140
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| P. A. Sanban
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| Vol #:
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| 140
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| C 10383
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| K. Biren
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| Vol #:
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| 140
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| C 10384
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| L. Hurr
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| Vol #:
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| 141
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| D. Glaze
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| Vol #:
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| L. Bushart
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| Vol #:
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| M. St Clair
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| Vol #:
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| R. Britt
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| Vol #:
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| 141
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| C 10389
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| P. P. Bamforth
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| Vol #:
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| 141
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| M. M. Fischer
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| Vol #:
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| 141
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| S. Straus
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| Vol #:
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| W. Patterson
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| Vol #:
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| C. Hudson
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| Vol #:
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| 141
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| J. Jones
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| Vol #:
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| 141
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| C 10395
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| E. Medlock
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| Vol #:
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| 141
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| C.. I. Malnby
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| Vol #:
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| 141
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| T. Stadler
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| Vol #:
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| S. Malone
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| Vol #:
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| S. Wanta
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| Vol #:
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| C. Johnston
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| Vol #:
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| F. Fry
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| Vol #:
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| M. B. Rollins
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| Vol #:
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| S. Kenig
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| Vol #:
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| Dorothy Kaloper
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| Vol #:
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| M. F. Smith
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| Vol #:
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| C. Petroff
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| Vol #:
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| J. ORourke
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| Vol #:
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| V. Price
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| Vol #:
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| 141
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| L. Measue
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| Vol #:
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| 141
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| C 10410
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| K. O'Malley
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| Vol #:
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| 141
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| B. Tam
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| Vol #:
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| 141
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| C. J. Brunsky
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| Vol #:
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| 141
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| M. E. Perez
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| Vol #:
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| 141
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| M. Brunsky
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| Vol #:
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| C. Grove
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| Vol #:
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| C. Sipe
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| Vol #:
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| 141
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| F. L. Kimura
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| Vol #:
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| L. Munich
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| Vol #:
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| L. Russell
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| Vol #:
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| Z. Westmark
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| Vol #:
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| D. Rudell
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| Vol #:
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| 141
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| M. L. Hanks
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| Vol #:
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| 141
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| M. Haddad
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| Vol #:
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| 141
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| N. Lally
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| Vol #:
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| R. Whitten
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| Vol #:
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| 141
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| L. J. Hicks
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| Vol #:
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| 141
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| C 10427
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| I. Hutlon
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| Vol #:
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| 141
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| J. Penton
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| Vol #:
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| 141
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| L. Brogwood
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| Vol #:
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| 141
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| C 10430
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| P. Hipps
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| Vol #:
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| 141
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| C 10431
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| Mary Meyer
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| Vol #:
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| 141
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| C 10432
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| M. Matchett
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| Vol #:
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| 141
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| MA. Hickerson
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| Vol #:
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| 141
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| C 10434
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| R. Guerrero
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| Vol #:
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| 141
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| C. Vitullo
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| Vol #:
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| P. Kempker
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| Vol #:
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| A. Dickenson
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| Vol #:
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| R. Peterson
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| Vol #:
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| M. C. Kuhn
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| Vol #:
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| H. H. Wilkin Jr
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| Vol #:
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| 141
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| Unreadable
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| Vol #:
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| M. Irvine
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| Vol #:
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| M. R. Anderson
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| V. Stwart
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| Vol #:
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| K. Armstrong
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| C. Thompson
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| M. Colombo
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| L. Kiernan
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| C. Jensen
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| L. Perez-Bouquet
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| M. Trsko
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| Vol #:
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| Sheyl Seton
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| Vol #:
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| Christine Embree
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| Vol #:
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| J. Shwedel
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| Vol #:
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| C. Decker
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| A. H. Canysill
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| H. Geraci
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| H. Geragl
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| N. Murry
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| Vol #:
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| K. Seide, MD
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| Vol #:
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| M. Fraser
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| Vol #:
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| L. Lavin
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| Vol #:
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| L. Wong
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| Vol #:
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| 141
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| M Borcback
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| Vol #:
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| L. DeVary
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| Vol #:
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| A. Kolovic
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| Vol #:
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| T. G. Campbell
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| M. Compain,M.D.
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| Vol #:
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| R. Megill
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| M. Penfield
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| K. Press
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| J. Anderson
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| L. Stuteville
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| Vol #:
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| D. Neumann
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| W. Hritz
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| S. Moore
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| S. Maroney
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| J. Friedman Edwards
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| Vol #:
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| P. J. Mard
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| Vol #:
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| L. Meyer
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| M. Alexander
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| V. Volpone
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| Vol #:
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| B. A. Roberts
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| D. Hastings
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| M. Woodall
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| Vol #:
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| A. Morgan
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| Vol #:
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| A. C. Garcia
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| M. Woodall
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| J. LeBlanc
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| M. L. Freeman, Ph.D.
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| Vol #:
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| 141
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| C 10524
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| S. Rider
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| Vol #:
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| 141
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| C 10525
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| D. Megill
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| Vol #:
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|
| C 10526
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| P. Bargardt, M.D.
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| Vol #:
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| 141
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| C 10527
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| B. Mango
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| C 10528
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| D. A. Foreman
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| Vol #:
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| 141
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| C 10529
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| B. Challenger
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| Vol #:
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| 141
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| C 10530
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| T. Dorsey
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| Vol #:
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| 141
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| C 10531
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| V. M. Boer
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| Vol #:
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| 141
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|
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| C 10532
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| J. Ginsburg
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| Vol #:
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| 141
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|
|
| C 10533
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| K. Hughes
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| Vol #:
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| 141
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| C 10534
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| D. Greenberg
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| Vol #:
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| 141
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| C 10535
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| C. Hauger
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| Vol #:
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| 141
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|
|
| C 10536
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| K. J. Sartoris
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| Vol #:
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| 141
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| C 10537
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| K. S. Gruenewald
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| Vol #:
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| 141
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|
| | | | | | | | |
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| C 10538
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| E. LeBlanc
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| Vol #:
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| 141
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| C 10539
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| S. Allegra
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| 141
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| C 10540
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| L. MacIntyre
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| Vol #:
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| 141
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| C 10541
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| E. Sciarra
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| Vol #:
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| 141
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| C 10542
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| C. Gallagher
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| Vol #:
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| 141
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| C 10543
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| M. Vinson Ph.D.
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| Vol #:
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| 141
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| C 10544
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| M. L. Becker
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| Vol #:
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| 141
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| C 10545
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| Ms. R. Singer
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| Vol #:
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| 141
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| C 10546
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| Mrs. D. Fultz
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| Vol #:
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| 141
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|
|
| C 10547
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| Mrs. K. Guerra
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| Vol #:
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| 141
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|
|
| C 10548
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| Ms. D. Zappin
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| Vol #:
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| 141
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|
|
| C 10549
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| Ms. T. J. Cordova
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| Vol #:
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| 141
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|
|
| C 10550
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| Mrs. N. Curtis
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| Vol #:
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| 141
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|
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| C 10551
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| Mrs. D. Kopcha
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| Vol #:
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| 141
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| C 10552
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| Ms. M. Lindley Steere
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| 141
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| C 10553
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| L. McDade
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| 141
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| C 10554
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| S. Bishop
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| 141
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| C 10555
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| J. Eagan
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| Vol #:
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| 141
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| C 10556
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| P. Blair
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| Vol #:
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| 141
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| C 10557
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| M. Small
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| Vol #:
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| 141
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| C 10558
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| G. Fowler
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| Vol #:
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| 141
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| C 10559
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| J. Fischer
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| Vol #:
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| 141
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| C 10560
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| J. Veers
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| Vol #:
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| 141
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| C 10561
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| S. Kleinert
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| Vol #:
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| 141
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| C 10562
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| C. Perreira
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| 141
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| K. Fargo
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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|
| LET 4
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
|
| 2006E-0026
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| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| LET 5
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| U.S. Patent and Trademark Office
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| 1
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|
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| 2006E-0040
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| Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
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| LET 4
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| U.S. Patent and Trademark Office
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| 1
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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| LET 4
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| | | | | | | | |
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| EC 1
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| Dr. Arthur Eisenbrey
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| Vol #:
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| 1
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| EC 1
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| up to data professional services
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| 1
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| EC 2
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| ActivBiotics Inc.
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| Vol #:
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| 1
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| 2006P-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| EC 1
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| Mr. D. Lowe
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| Vol #:
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| 1
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| 2006P-0218
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| To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension
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| ACK 1
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| FDA/ DDM to West-ward Pharmaceutical Corp.
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| Vol #:
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| 1
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|
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| CP 1
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| West-ward Pharmaceutical Corp.
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| Vol #:
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| 1
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