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| Dockets Entered
On March 28, 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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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 2003E-0243
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| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
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| 2003E-0244
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| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| 2004E-0325
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| Patent Extension for Myfortic (mycophenolic acid) Delayed-Release Tablets, U.S. Patent No. 6,306,900
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| |
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| 2006P-0243
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| Qualified Health Claim: (QHC) Corn oil and corn oil containing foods and heart disease
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| 2007N-0091
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety a
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19714
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| Global Pharmatech Inc.
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| Vol #:
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| 174
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| LET 19715
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| Next Proteins, Inc.
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| Vol #:
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| 174
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| LET 19716
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| Next Proteins, Inc.
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| Vol #:
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| 174
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| LET 19717
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| Next Proteins, Inc.
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| Vol #:
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| 174
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| LET 19718
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| Herb Pharm
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| Vol #:
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| 174
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| LET 19719
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| NBTY Inc.
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| Vol #:
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| 174
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| LET 19720
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| NBTY Inc.
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| Vol #:
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| 174
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| LET 19721
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| NBTY Inc.
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| Vol #:
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| 174
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| LET 19722
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| NBTY Inc.
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| Vol #:
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| 174
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| LET 19723
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19724
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| Santal Solutions LLC
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| Vol #:
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| 174
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| LET 19725
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| Bodyhealth.com Corporation
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| Vol #:
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| 174
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| LET 19726
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| FoodScience Corporation
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| Vol #:
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| 174
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| LET 19727
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| Tabak's Health Products
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| Vol #:
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| 174
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| LET 19728
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| Source Naturals
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| Vol #:
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| 174
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| LET 19729
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| FoodScience Corporation
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| Vol #:
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| 174
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| LET 19730
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19731
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19732
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19733
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19734
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19735
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19736
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| Jarrow Formulas Inc.
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| Vol #:
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| 174
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| LET 19737
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| Crayhon Research, Inc.
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| Vol #:
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| 174
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| LET 19738
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| Hillestad Pharmaceuticals USA, Inc.
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| Vol #:
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| 174
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| LET 19739
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| Natrol, Inc.
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| Vol #:
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| 174
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| LET 19740
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| Douglas Laboratories
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| Vol #:
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| 174
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| LET 19741
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| Hillestad Pharmaceuticals USA, Inc.
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| Vol #:
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| 174
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| M 1
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| FDA/OC
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| Vol #:
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| 1
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| 2003E-0243
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| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2003E-0244
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| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 460
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| N. Sterling
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| Vol #:
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| 41
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| C 461
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| I. Buiss
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| Vol #:
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| 41
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| C 462
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| E.M. Markelos
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| Vol #:
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| 41
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| C 463
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| P. Fullem
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| Vol #:
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| 41
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| C 464
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| Zartarian
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| Vol #:
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| 41
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| C 465
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| G. LaPorte
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| Vol #:
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| 41
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| C 466
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| P. Binnco
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| Vol #:
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| 41
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| C 467
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| Dr. Thandeta
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| Vol #:
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| 41
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| C 468
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| J. Burn
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| Vol #:
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| 41
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| C 469
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| T. Taylor
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| Vol #:
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| 41
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| C 470
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| B. Greco
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| Vol #:
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| 41
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| C 471
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| T. Light
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| Vol #:
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| 41
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| C 472
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| R. Weigle
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| Vol #:
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| 41
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| C 473
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| C. Louis
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| Vol #:
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| 41
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| C 474
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| C. Louis
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| Vol #:
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| 41
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| C 475
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| P. Love
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| Vol #:
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| 41
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| C 476
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| C. Mason
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| Vol #:
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| 41
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| C 477
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| G. Lane
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| Vol #:
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| 41
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| C 478
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| A. Rhodes
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| Vol #:
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| 41
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| C 479
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| J. Mardavich
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| Vol #:
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| 41
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| C 480
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| K. LeFauve
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| Vol #:
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| 41
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| C 481
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| R. Hamilton
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| Vol #:
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| 41
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| C 482
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| W. Hamilton
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| Vol #:
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| 41
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| C 483
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| D. Pulliam
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| Vol #:
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| 41
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| C 484
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| P. Baskis
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| Vol #:
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| 41
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| C 485
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| T. J. Ley
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| Vol #:
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| 41
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| C 486
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| T. Baskis
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| Vol #:
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| 41
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| C 487
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| G. Caccia
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| Vol #:
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| 41
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| C 488
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| C. Carroll
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| Vol #:
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| 41
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| C 489
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| M. Cosgrove
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| Vol #:
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| 41
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| C 490
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| S. Stauty
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| Vol #:
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| 41
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| C 491
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| J. Holden
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| Vol #:
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| 41
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| C 492
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| F. Andrews
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| Vol #:
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| 41
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| C 493
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| R. Blayer
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| Vol #:
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| 41
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| C 494
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| S. Szczepaniec
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| Vol #:
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| 41
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| EC 3976
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| Mrs. Rae Lynn Crocker
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| Vol #:
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| 22
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| EC 3977
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| Mrs. D Roberts
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| Vol #:
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| 22
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| EC 3978
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| Mrs. Carrie Lancaster
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| Vol #:
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| 22
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| EC 3979
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| Ms. Dianne Douglas
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| Vol #:
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| 22
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| EC 3980
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| Ms. Andrea Yarger
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| Vol #:
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| 22
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| EC 3981
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| Ms. Dianne Douglas
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| Vol #:
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| 22
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| EC 3982
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| Ms. Kymberly Hudson
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| Vol #:
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| 22
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| EC 3983
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| Mr. Les Crue
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| Vol #:
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| 22
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| EC 3984
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| Miss. Lana Lane
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| Vol #:
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| 22
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| EC 3985
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| Ms. Linda Lee ManLey
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| Vol #:
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| 22
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| EC 3986
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| Ms. Tamara Lynch
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| Vol #:
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| 22
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| EC 3987
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| Ms. Kyle Culver
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| Vol #:
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| 22
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| EC 3988
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| Mrs. Angelica Kashulines
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| Vol #:
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| 22
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| EC 3989
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| Ms. Johanna Fentress
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| Vol #:
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| 22
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| EC 3990
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| Dr. Brice Dupoyet
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| Vol #:
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| 22
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| EC 3991
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| Mrs. Shannon Chamberlain
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| Vol #:
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| 22
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| EC 3992
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| Mrs. Chanin Elias
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| Vol #:
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| 22
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| EC 3993
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| Ms. Kimberly Fischer
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| Vol #:
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| 22
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| EC 3994
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| Miss. melinda bashen
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| Vol #:
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| 22
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| EC 3995
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| Mr. Louis Lorenzi-Prince
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| Vol #:
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| 22
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| EC 3996
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| Miss. dawn storm
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| Vol #:
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| 22
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| EC 3997
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| Ms. Kimberley Thomas
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| Vol #:
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| 22
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| EC 3998
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| Mrs. Susan Hodges
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| Vol #:
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| 22
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| EC 3999
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| Ms. Leah Hammer
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| Vol #:
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| 22
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| EC 4000
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| Mrs. Tiffani Smith
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| Vol #:
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| 22
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| EC 4001
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| n/a
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| Vol #:
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| 22
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| EC 4002
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| Ms. Jessie Liu
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| Vol #:
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| 22
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| EC 4003
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| Altarriba Foundation
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| Vol #:
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| 22
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| EC 4004
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| Mrs. Lynnette Raines
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| Vol #:
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| 22
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| EC 4005
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| Mrs. Robyn Bishop
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| Vol #:
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| 22
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| EC 4006
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| Mr. SAMUEL SMITH
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| Vol #:
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| 22
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| EC 4007
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| Mr. Michael McCartin
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| Vol #:
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| 22
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| EC 4008
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| Mr. Patrick Dwyer
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| Vol #:
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| 22
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| EC 4009
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| Mr. Chad Russell
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| Vol #:
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| 22
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| EC 4010
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| Mr. Jared Brenner
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| Vol #:
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| 22
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| EC 4011
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| Mrs. D Cooper
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| Vol #:
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| 22
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| EC 4012
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| Ms. Cher Miller
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| Vol #:
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| 22
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| EC 4013
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| Ms. Monica Drake
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| Vol #:
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| 22
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| EC 4014
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| Mr. Shane Taylor
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| Vol #:
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| 22
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| EC 4015
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| Mr. William McGarry
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| Vol #:
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| 22
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| EC 4016
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| Ms. Lynda de Rohan Barondes
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| Vol #:
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| 22
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| EC 4017
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| Mrs. Kim Bearsch
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| Vol #:
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| 22
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| EC 4018
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| Ms. Elsa Bertolin
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| Vol #:
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| 22
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| EC 4019
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| Ms. Gwen Doddy Lowit
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| Vol #:
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| 22
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| EC 4020
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| Ms. Natalie Gray
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| Vol #:
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| 22
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| EC 4021
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| Ms. j lissauer
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| Vol #:
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| 22
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| EC 4022
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| Mrs. Gina Hafner
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| Vol #:
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| 22
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| EC 4023
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| -
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| Vol #:
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| 22
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| EC 4024
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| Mr. Frank Seger
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| Vol #:
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| 22
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| EC 4025
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| Ms. Janis Kinslow
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| Vol #:
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| 22
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| EC 4026
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| Mrs. Kimberly McClelland
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| Vol #:
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| 22
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| EC 4027
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| Ms. Kirsten Thompson
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| Vol #:
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| 22
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| EC 4028
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| Mr. Tom Tamplin
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| Vol #:
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| 22
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| |
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| EC 4029
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| Mr. Bobbie Flowers
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| Vol #:
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| 22
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| |
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| EC 4030
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| Mrs. Donna Liolis
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| Vol #:
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| 22
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| EC 4031
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| Ms. Jamie Becker
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| Vol #:
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| 22
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| |
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| EC 4032
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| Ms. Erin Bolton
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| Vol #:
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| 22
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| |
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| EC 4033
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| Miss. Samantha Free
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| Vol #:
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| 22
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| |
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| EC 4034
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| Mrs. sherry weiland
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| Vol #:
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| 22
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| |
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| EC 4035
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| Mrs. Elizabeth Nicholas
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| Vol #:
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| 22
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| |
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| EC 4036
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| Mr. Robert Fitzgerald
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| Vol #:
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| 22
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|
| | | | | | | | |
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| |
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| EC 4037
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| Ms. Lori Colt
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| Vol #:
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| 22
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| |
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| EC 4038
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| Mr. Steven Tempelman
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| Vol #:
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| 22
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| |
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| EC 4039
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| Ms. Liza Burney
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| Vol #:
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| 22
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| |
|
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| EC 4040
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| Miss. Leah Jones
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| Vol #:
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| 22
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| |
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| EC 4041
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| Mr. J. Stahlberg
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| Vol #:
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| 22
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| |
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| EC 4042
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| Ms. Karla LaVoie
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| Vol #:
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| 22
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| |
|
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| EC 4043
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| Miss. Jenny Vegan
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| Vol #:
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| 22
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| |
|
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| EC 4044
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| Mrs. Sandra Shaughnessy
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| Vol #:
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| 22
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| |
|
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| EC 4045
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| Miss. Christina Tasca
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| Vol #:
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| 22
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| |
|
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| EC 4046
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| Dr. Dan Koller
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| Vol #:
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| 22
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| |
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| EC 4047
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| Ms. Patricia Baldwin
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| Vol #:
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| 22
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| |
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| EC 4048
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| Mrs. BJ Hartman
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| Vol #:
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| 22
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| |
|
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| EC 4049
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| Mrs. Alicia Norrigan
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| Vol #:
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| 22
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| |
|
|
| EC 4050
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| Ms. marcy raich
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| Vol #:
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| 22
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| |
|
|
| EC 4051
|
| Mrs. Susan Hemple
|
| Vol #:
|
| 22
|
| |
|
|
| 2004E-0319
|
| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-13)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0325
|
| Patent Extension for Myfortic (mycophenolic acid) Delayed-Release Tablets, U.S. Patent No. 6,306,900
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-13)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0243
|
| Qualified Health Claim: (QHC) Corn oil and corn oil containing foods and heart disease
|
| |
|
|
| ANS 1
|
| FDA/CFSAN to Richard O. Wood, The Wood Burditt Group LLC
|
| Vol #:
|
| 12
|
| |
|
|
| REF 1
|
| References
|
| Vol #:
|
| 12
|
| |
|
|
| 2007N-0091
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety a
|
|
|
|
|
|
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| NHC 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0074
|
| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
|
| |
|
|
| LET 1
|
| FDA/CBER to Joshua M. Sharfstein, M.D.
|
| Vol #:
|
| 1
|
|
|
