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| Dockets Entered
On May 7, 2007
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| Docket #
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| Title
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006E-0003
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| Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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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-0250
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| Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
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| 2006E-0486
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| Patent Extension Application for Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent), U.S. Patent No. 5,626,851
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| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| 2006E-0502
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| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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| 2007E-0001
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| Patent Extension Application for METVIXIA (methyl aminoevulinate hydrochloride), U.S. Patent No. 6,034,267
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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| 2007E-0145
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| Patent Extension Application for INVEGA (paliperidone), U.S. Patent No. 5,518,952
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 734
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| K. DaPrato
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| Vol #:
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| 56
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| C 735
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| d. Oberholtzer
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| Vol #:
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| 56
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| C 736
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| D. Everett
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| Vol #:
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| 56
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| C 737
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| D. Wurst
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| Vol #:
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| 56
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| C 738
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| J. Parker
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| Vol #:
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| 56
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| C 739
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| L. Riehm
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| Vol #:
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| 56
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| C 740
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| C. Soullas
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| Vol #:
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| 56
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| C 741
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| R. Leal
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| Vol #:
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| 56
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| C 742
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| J. Roloff
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| Vol #:
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| 56
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| C 743
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| C. Leal
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| Vol #:
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| 56
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| C 744
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| W. Vogel
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| Vol #:
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| 56
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| C 745
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| M. Ramos
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| Vol #:
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| 56
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| C 746
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| K. Barlett
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| Vol #:
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| 56
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| C 747
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| S. van Asch van Wyck
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| Vol #:
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| 56
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| C 748
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| K. Porter
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| Vol #:
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| 56
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| C 749
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| S. Woodrup
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| Vol #:
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| 56
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| C 750
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| J. Cox
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| Vol #:
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| 56
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| C 751
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| M. Hass
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| Vol #:
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| 56
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| C 752
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| D. Schumann
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| Vol #:
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| 56
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| C 753
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| M. Lukasiewicz
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| Vol #:
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| 56
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| C 754
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| A. Reinbott
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| Vol #:
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| 56
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| C 755
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| N. Baumgardner
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| Vol #:
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| 56
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| C 756
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| Trinidad & Tobago for the Prevention of Cruelty to Animals
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| Vol #:
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| 56
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| C 757
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| signature unknown
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| Vol #:
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| 56
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| C 758
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| American Clinical Laboratory Associaton (ACLA)
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| Vol #:
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| 56
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| C 759
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| H. Rife
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| Vol #:
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| 56
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| C 760
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| L. Peipins
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| Vol #:
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| 56
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| C 761
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| V. Myers
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| Vol #:
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| 56
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| C 762
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| J. Bianco
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| Vol #:
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| 56
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| C 763
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| F. Butler
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| Vol #:
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| 56
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| C 764
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| A. DeHart
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| Vol #:
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| 56
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| C 765
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| Prairie Farms Dairy INC
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| Vol #:
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| 56
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| C 766
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| D. Keyser
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| Vol #:
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| 56
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| C 767
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| L. Kick
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| Vol #:
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| 56
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| C 768
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| L. Brady
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| Vol #:
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| 56
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| C 769
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| R. Omdalen
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| Vol #:
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| 56
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| C 770
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| Star Kay White Inc.
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| Vol #:
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| 56
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| C 771
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| D. Limanowski
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| Vol #:
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| 56
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| C 772
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| Consumer Union
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| Vol #:
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| 56
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| C 773
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| C. Brown
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| Vol #:
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| 56
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| C 774
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| D. Andrick
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| Vol #:
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| 56
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| C 775
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| Sargento Foods Inc
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| Vol #:
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| 56
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| C 776
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| Consumer Inion
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| Vol #:
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| 56
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| C 777
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| Consumer Union
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| Vol #:
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| 66
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| C 778
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| Consumer Union
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| Vol #:
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| 66
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| C 779
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| Dean Foods Company
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| Vol #:
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| 67
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| C 780
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| L. Hughes
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| Vol #:
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| 67
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| C 781
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| Kraft Goods Global, Inc
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| Vol #:
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| 67
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| C 782
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| D. Davis
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| Vol #:
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| 67
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| C 783
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| J. Lucier
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| Vol #:
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| 67
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| C 784
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| A. Alvarez
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| Vol #:
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| 67
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| C 785
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| G. Mecklenburg
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| Vol #:
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| 67
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| C 786
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| J. Smith
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| Vol #:
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| 67
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| C 787
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| N. Patel
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| Vol #:
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| 67
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| C 788
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| unknown signature
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| Vol #:
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| 67
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| EXT 13
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| International Dairy Foods Association (IDFA)
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| Vol #:
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| 66
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| TR 1
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| Transcript, 4/16/07
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| Vol #:
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| 243
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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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| C 18303
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| S. Montgomery
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| Vol #:
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| 198
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| C 18304
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| R. Hafner
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| Vol #:
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| 198
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| EC 104
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| Therapeutic Dimensions
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| Vol #:
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| 6
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| EC 105
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| Licensed Massage Therapist
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| Vol #:
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| 6
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| EC 106
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| Mr. Harold Meier
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| Vol #:
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| 6
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| EC 107
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| Ms. Judith Labadie
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| Vol #:
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| 6
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| EC 108
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| Ms. Connie Walsh
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| Vol #:
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| 6
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| EC 109
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| Mrs. Jessica Gallipeau
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| Vol #:
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| 6
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| EC 110
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| Mr. Michael Gallipeau
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| Vol #:
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| 6
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| EC 111
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| Mrs. Dawna Bishop Stevens
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| Vol #:
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| 6
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| EC 112
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| Mrs. I. H. Mitchell
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| Vol #:
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| 6
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| EC 113
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| Mr. Mike Reed
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| Vol #:
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| 6
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| EC 114
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| Mr. Wayne Gavalyas
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| Vol #:
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| 6
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| EC 115
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| Mr. Ron Kostreba
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| Vol #:
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| 6
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| EC 116
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| Mrs. Joan Troth
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| Vol #:
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| 6
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| EC 117
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| Mrs. Candi Gaitanis
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| Vol #:
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| 6
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| EC 118
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| Mrs. Diana Tippit
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| Vol #:
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| 6
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| EC 119
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| Mr. Mitchell Souza
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| Vol #:
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| 6
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| EC 120
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| Mrs. Sandra Berlin
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| Vol #:
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| 6
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| EC 121
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| Mrs. Sandra Berlin
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| Vol #:
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| 6
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| EC 122
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| Ms. Edith Griffin
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| Vol #:
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| 6
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| EC 123
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| Ms. Cory Sica
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| Vol #:
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| 6
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| EC 124
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| Mrs. Anna Possenti
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| Vol #:
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| 6
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| EC 125
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| SCOR CCC
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| Vol #:
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| 6
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| 2006E-0003
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| Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
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| LET 3
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| U.S. Patent and Trademark Office to NitroMed, Inc.
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| Vol #:
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| 1
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| CEP 1
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| U.S. Patent and Trademark Office to Eli Lilly and Company
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| Vol #:
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| 2
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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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| CR 1
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| U.S. Patent and Trademark Office to Heller Ehrmann, LLP
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| Vol #:
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| 1
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| 2006E-0250
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| Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
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| LET 3
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| U.S. Patent and Trademark Office to Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006E-0486
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| Patent Extension Application for Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent), U.S. Patent No. 5,626,851
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| LET 3
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| LET 3
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| 2006E-0502
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| Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
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| LET 3
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| U.S. Patent & Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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| EC 3
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| Mrs. Laura OKane
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| Vol #:
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| 1
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| 2007E-0001
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| Patent Extension Application for METVIXIA (methyl aminoevulinate hydrochloride), U.S. Patent No. 6,034,267
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| LET 3
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| U.S. Patent and Trademark Offce to Kenyon & Kenyon
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| Vol #:
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| 1
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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| LET 3
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| 2007E-0145
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| Patent Extension Application for INVEGA (paliperidone), U.S. Patent No. 5,518,952
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| LET 2
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| Number not used
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 145
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| Bayer, Mark
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| Vol #:
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| 1
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| EAPE 146
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| Saner, Gary
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| Vol #:
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| 1
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| EAPE 147
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| hankin, joan
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| Vol #:
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| 1
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| EAPE 148
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| Sicat, Brigitte
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| Vol #:
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| 1
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