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| Dockets Entered
On July 11, 2005
Table of Contents
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| Docket #
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| Title
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2002P-0166
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| Print clear, legible & intelligible product expiration date
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003V-0426
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| Laser Light Show
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0534
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-The Counter (OTC) Drug Product Labeling
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| 2004N-0541
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004V-0053
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| Laser Light Show
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| 2004V-0449
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| Laser Light Show
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| 2005A-0015
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| Request for Advisory Opinion Concerning "Orange Book" Listing of Patents
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2005P-0156
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| Permission to file an abbreviated new drug application for Baclofen Oral Solution, 10 mg/ 5mL
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| 2005V-0052
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| Projector for a Laser Light Show
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| 2005V-0280
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| Projector for a Laser Light Show
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| 1997P-0329
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| Require Quantitative Labeling of Caffeine Content
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| EMC 115
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| K. Slick
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| Vol #:
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| 7
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| EMC 116
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| M. Mau
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| Vol #:
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| 7
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| EMC 117
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| No signature
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| Vol #:
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| 7
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| EMC 118
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| No signature
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| Vol #:
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| 7
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7493
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| D. Schulte
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| Vol #:
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| 319
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| C 7494
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| L. Garvey
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| Vol #:
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| 319
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| C 7495
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| J. Capozzelli
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| Vol #:
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| 319
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| EMC 4337
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| A. Wedgwood
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| Vol #:
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| 320
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| EMC 603
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| J. Smith
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| Vol #:
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| 30
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| EMC 604
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| J. Denby
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| Vol #:
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| 30
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| EMC 605
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| L. Hoffman
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| Vol #:
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| 30
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| EMC 606
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| A. Wiedel
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| Vol #:
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| 30
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| EMC 607
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| M. Pietzak, MD
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| Vol #:
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| 30
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| EMC 608
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| B. Hicks
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| Vol #:
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| 30
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| EMC 609
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| D and M Ulmer
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| Vol #:
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| 30
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| EMC 610
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| Gia
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| Vol #:
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| 30
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| EMC 611
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| B. Hunter
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| Vol #:
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| 30
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| EMC 612
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| C. Alfonso
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| Vol #:
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| 30
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| EMC 613
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| M. Waid, Phd
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| Vol #:
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| 30
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| 2002P-0166
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| Print clear, legible & intelligible product expiration date
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| C 4
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| B. Rogers
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| Vol #:
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| 1
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| C 5
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| G. Mondrut
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| Vol #:
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| 1
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| EMC 6
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| M. Madden
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| Vol #:
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| 1
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| EMC 7
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| J. Cornwell
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| Vol #:
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| 1
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| EMC 8
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| A. McGowan
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| Vol #:
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| 1
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| EMC 9
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| K. Anderson
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| Vol #:
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| 1
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| EMC 10
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| No signature
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| Vol #:
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| 1
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| C
42
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| Pennsylvania Medical Assistance (MA) Program
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| Vol #:
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| 11
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| 2003V-0426
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| Laser Light Show
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| VRA
2
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| HFZ-200 to Celebration City
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| Vol #:
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| 1
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| C 7
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| E. Crowley
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| Vol #:
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| 2
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| C
9
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| Children's Oncology Group
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| Vol #:
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| 2
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| C
10
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| Memorial Sloan-Kettering Cancer Center
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| Vol #:
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| 2
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| 2004N-0534
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-The Counter (OTC) Drug Product Labeling
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| C
4
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| Talecris Biotherapeutics, Inc. (Talecris)
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| Vol #:
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| 1
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| 2004N-0541
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| LET
14
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| HFS-800 to Hogan & Hartson, LLP
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| Vol #:
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| 3
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| 2004V-0053
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| Laser Light Show
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| VRA
2
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| HFZ-2005 to Minolta Planetarium, De Anza College
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| Vol #:
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| 1
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| 2004V-0449
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| Laser Light Show
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| VRA
1
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| HFZ-200 to Pacific Science Center - Adobe Dome
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| Vol #:
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| 1
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| 2005A-0015
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| Request for Advisory Opinion Concerning "Orange Book" Listing of Patents
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| LET
1
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| HFD-005 to GlaxoSmithKline
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| Vol #:
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| 1
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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| C
2
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| Aspreva Pharmaceuticals (Aspreva)
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
3
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| Millennium Pharmaceuticals, Inc. (Millennium)
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| Vol #:
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| 1
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| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| C
1
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| TR
1
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| Transcript of the 05/23/2005 Public Meeting
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| Vol #:
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| 2
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| C
2
Att
1, Att
2
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| EBI A Biomet Company
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| Vol #:
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| 3
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| 2005P-0156
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| Permission to file an abbreviated new drug application for Baclofen Oral Solution, 10 mg/ 5mL
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| WDL
1
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| Phase V Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005V-0052
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| Projector for a Laser Light Show
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| VRA
1
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| HFZ-200 to Black Oak Casino
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| Vol #:
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| 1
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| 2005V-0280
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| Projector for a Laser Light Show
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| ACK
1
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| HFA-305 to Sidram Services, Inc.
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| Vol #:
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| 1
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| VAR
1
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| Sidram Services, Inc.
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| Vol #:
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| 1
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