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| Dockets Entered
On July 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1999F-0719
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| Safe use Olestra in place of Fats and Oils in Prepackaged
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2002P-0520
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| Reclassification of Beta-Tricalcium Phosphate,
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| 2003E-0251
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| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
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| 2003E-0257
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| Patent Extension for Neotame, 5,480,668
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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| 2004D-0178
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| Guidance for Industry and FDA Staff; Draft Class II Special Controls Guidance Document: Dental Bone Grafting Material; Availability
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| 2004M-0203
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| BP030025 / 0 Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
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| 2004P-0280
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| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
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| 2004P-0281
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| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
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| 2004P-0282
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| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
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| 2004V-0292
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| Laser Light Show
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
189
Attachments
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| Loders Croklann B.V.
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| Vol #:
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| 139
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| RPT
190
Notification
Report
Appendices
References
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| ProNutrient Technologies, Inc
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| Vol #:
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| 140
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| RPT
191
Attachment
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| Nokomis Research Inc
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| Vol #:
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| 141
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| RPT
192
Attachment
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| ISC (Innovative Supplement Concepts)
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| Vol #:
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| 141
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| RPT
193
Attachment
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| New Cewntury Company
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| Vol #:
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| 141
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| 1999F-0719
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| Safe use Olestra in place of Fats and Oils in Prepackaged
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 242
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| Center for Veterinary Medicine
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| Vol #:
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| 419
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| EXB 243
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| Center for Veterinary Medicine
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| Vol #:
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| 419
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| 2002P-0520
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| Reclassification of Beta-Tricalcium Phosphate,
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| BKG 2
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| Background Information References 1-5
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| Vol #:
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| 1
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2003E-0251
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| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
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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-0257
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| Patent Extension for Neotame, 5,480,668
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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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| | | | | | | | |
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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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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-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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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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| 2004D-0178
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| Guidance for Industry and FDA Staff; Draft Class II Special Controls Guidance Document: Dental Bone Grafting Material; Availability
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004M-0203
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| BP030025 / 0 Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
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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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| 2004P-0280
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| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
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| ACK
1
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| HFA-305 to Nico Worldwide, LLC
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| Vol #:
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| 1
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| 2004P-0281
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| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
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| ACK
1
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| HFA-305 to Nico Worldwide, LLC
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| Vol #:
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| 1
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| 2004P-0282
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| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
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| ACK
1
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| HFA-305 to Nico Worldwide, LLC
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| Vol #:
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| 1
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| 2004V-0292
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| Laser Light Show
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| ACK 1
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| HFA-305 to Arctic Ice Arena
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| Vol #:
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| 1
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| VAR
1
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| Arctic Ice Arena
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| Vol #:
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| 1
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