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| Dockets Entered
On December 2, 2003
Table of Contents
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| Docket #
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| Title
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1999N-1168
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| Public Health Impact of Foodborne Listeria Monocytogenes
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| 2002D-0306
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| Dental Sonography and Jaw Tracking Devices
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0305
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| Dental Sonography Device & Jaw Tracking Device
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Dugs of Abuse Screening Tests; Availability
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| 2003E-0153
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| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
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| 2003E-0250
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| Patent Extension for Invanz (ertapenem sodium), 5,478,820
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| 2003E-0253
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| Patent Extension for Lexapro (escitalopram oxalate), 34,712
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003V-0543
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| A Projector for a Laser Light Show
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| ACK 5
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| Number not used
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| Vol #:
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| 8
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| CP 1
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| Number not used
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| Vol #:
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| 8
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11741
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| Health From The Sun
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| Vol #:
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| 92
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| LET
11742
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| Health From The Sun
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| Vol #:
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| 92
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| LET
11743
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| National Vitamin Company, Inc.
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| Vol #:
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| 92
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| LET
11744
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 92
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| LET
11745
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| National Vitamin Company, Inc.
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| Vol #:
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| 92
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| LET
11746
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| National Vitamin Company, Inc.
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| Vol #:
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| 92
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| LET
11747
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| National Vitamin Company, Inc.
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| Vol #:
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| 92
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| LET
11748
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| Silver Sage, LLC
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| Vol #:
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| 92
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| LET
11749
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| A. G. Waterhouse, LLC
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| Vol #:
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| 92
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| LET
11750
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11751
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11752
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11753
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11754
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11755
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11756
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11757
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11758
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11759
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11760
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| Rexall Sundwon, Inc.
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| Vol #:
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| 92
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| LET
11761
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| Rexall Sundown, Inc.
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| Vol #:
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| 92
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| LET
11762
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11763
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11764
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11765
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11766
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11767
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11768
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| Rexall Sundown, Inc.
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| Vol #:
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| 93
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| LET
11769
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| Lectin Labs Ltd.
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| Vol #:
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| 93
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| LET
11770
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| Lectin Labs Ltd.
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| Vol #:
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| 93
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| LET
11771
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| Natural Organics Inc.
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| Vol #:
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| 93
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| LET
11772
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| Solstice Medicine Company
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| Vol #:
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| 93
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| LET
11773
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| Solstice Medicine Company
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| Vol #:
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| 93
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| LET
11774
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| Perrigo Company of South Carolina
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| Vol #:
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| 93
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| LET
11775
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| Perrigo Company of South Carolina
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| Vol #:
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| 93
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| LET
11776
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| Perrigo Company of South Carolina
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| Vol #:
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| 93
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| LET
11777
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| National Vitamin Company, Inc.
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| Vol #:
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| 93
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
734
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| HFS-800 to Body Wise International, Inc.
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| Vol #:
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| 22
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| LET
735
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| HFS-800 to LifeSpan Nutrition
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| Vol #:
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| 22
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| 1999N-1168
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| Public Health Impact of Foodborne Listeria Monocytogenes
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| BKG
2
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| Background Material
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| Vol #:
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| 21
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| NAD
3
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| FDA
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| Vol #:
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| 21
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| NCR
1
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| FDA
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| Vol #:
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| 21
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| 2002D-0306
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| Dental Sonography and Jaw Tracking Devices
|
| |
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| C
169
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| Alanbe Companies
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| Vol #:
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| 15
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| EMC
106
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| Atofina Chemicals Inc
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| Vol #:
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| 15
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| 2002N-0305
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| Dental Sonography Device & Jaw Tracking Device
|
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| | | | | | | | |
| |
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Dugs of Abuse Screening Tests; Availability
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
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| 1
|
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|
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| NAD
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0153
|
| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0250
|
| Patent Extension for Invanz (ertapenem sodium), 5,478,820
|
| |
|
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| N
1
|
| FDA
|
| Vol #:
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| 1
|
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|
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| 2003E-0253
|
| Patent Extension for Lexapro (escitalopram oxalate), 34,712
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| |
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| N
1
|
| FDA
|
| Vol #:
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| 1
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 8
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| C Clulee
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| Vol #:
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| 1
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| EMC 9
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| L Butler
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| Vol #:
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| 1
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| EMC 10
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| K Devenport
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| Vol #:
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| 1
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| EMC
11
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| JVD Inc
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| Vol #:
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| 1
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| 2003V-0543
|
| A Projector for a Laser Light Show
|
| |
|
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| ACK 1
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| HFA-305 to Pulse
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| Vol #:
|
| 1
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| VAR
1
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| Pulse
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| Vol #:
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| 1
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