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| Dockets Entered
On November 18, 2003
Table of Contents
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| Docket #
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| Title
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1998F-0522
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| Formaldehyde Treated oilseed meal and fats for dairy & beef
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998V-0657
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| Laser Lighting Effects
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002N-0471
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| Cox-2 Inhibitors: Vioxx and Celebrex
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| 2002P-0163
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| Expedite Over-the-Counter Approval for Desloratidine
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| 2002P-0431
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| Delcobese Tablets and Capsules
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| 2002V-0488
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| Laser Light Show
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0324
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| Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing
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| 2003N-0468
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| Medical Devices; Effective Date of Requirement for Premarket
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| 2003P-0107
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| Synthroid (levothyroxine sodium) Tablets (NDA 21-402)
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| 2003P-0113
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| Levoxyl (levothyroxine sodium) tablets (NDA #21-301)
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| 2003P-0210
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| Withdraw decision granting petitions 03P-0107 and 03P-0113
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0300
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| Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons
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| 2003V-0316
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| Laser Light Show
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| C 4048
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| William (Bill) Popin
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| Vol #:
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| 374
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| 1998F-0522
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| Formaldehyde Treated oilseed meal and fats for dairy & beef
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| FONS
1
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| HFV-220
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| Vol #:
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7273
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| Kathleen Garron
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| Vol #:
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| 303
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| C 7274
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| Monica Lebelt
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| Vol #:
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| 303
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| 1998V-0657
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| Laser Lighting Effects
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| VRA
3
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| HFZ-300 to Viejas Casino and Turf Club
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| Vol #:
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| 1
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| C
79
Tab 1,
2, 3,
4, 5,
6,
7
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| Public Citizen and The Center for Food Safety
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| Vol #:
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| 8
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| C
77
Tab 1,
2, 3,
4, 5,
6.
7
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| Public Citizen and The Center for Food Safety
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| Vol #:
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| 8
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| C
76
Tab 1,
2, 3,
4, 5,
6.
7
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| Public Citizen and The Center for Food Safety
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| Vol #:
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| 6
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| C
80
Tab 1,
2, 3,
4, 5,
6.
7
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| Public Citizen and The Center for Food Safety
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| Vol #:
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| 6
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| C
75
Tab 1,
2, 3,
4, 5,
6.
7
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| Public Citizen and The Center for Food Safety
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| Vol #:
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| 8
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| C
166
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| Asociacion de Exportadores de Chile, AG (ASOEX)
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| Vol #:
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| 15
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| C
235
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| Asociacion de Exportadores de Chile, AG (ASOEX)
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| Vol #:
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| 17
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| 2002N-0471
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| Cox-2 Inhibitors: Vioxx and Celebrex
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| LET
2
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| HF-22 to Honorable Sterling Johnson, Jr.
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| Vol #:
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| 1
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| 2002P-0163
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| Expedite Over-the-Counter Approval for Desloratidine
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| C
6
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| Honorable Sanford D. Bishop, Jr.
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| Vol #:
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| 1
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| 2002P-0431
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| Delcobese Tablets and Capsules
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| LET
3
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| HFD-007 to Sonnenschein Nath & Rosenthal
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| Vol #:
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| 1
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| 2002V-0488
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Robert Urschel
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| C 13 / ANS
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| HFS-306 to Ed Moon
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| Vol #:
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| 3
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| 2003N-0324
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| Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing
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| CR
1
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| Buchanan Ingersoll
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| Vol #:
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| 1
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| CR
2
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| Buchanan Ingersoll
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| Vol #:
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| 1
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| 2003N-0468
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| Medical Devices; Effective Date of Requirement for Premarket
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| N 1
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| Number not used
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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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| 2003P-0107
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| Synthroid (levothyroxine sodium) Tablets (NDA 21-402)
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| PDN
1
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| HF-22 to Hogan & Hartson,
LLP
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| Vol #:
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| 1
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| 2003P-0113
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| Levoxyl (levothyroxine sodium) tablets (NDA #21-301)
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| PDN
1
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| HF-22 to Hogan & Hartson,
LLP
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| Vol #:
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| 1
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| 2003P-0210
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| Withdraw decision granting petitions 03P-0107 and 03P-0113
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| PDN
1
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| HF-22 to Hogan & Hartson,
LLP
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| Vol #:
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| 1
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 41
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| Nora M. Cuddy
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| Vol #:
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| 6
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| C
9
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| Abigail Alliance and the Washington Legal Foundation
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| Vol #:
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| 1
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| 2003P-0300
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| Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons
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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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| 2003V-0316
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Imagery Laser
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| Vol #:
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| 1
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