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| Dockets Entered
On February 3, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1986P-0224
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| LD50 ACUTE TOXICITY TEST
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1996N-0244
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| Food Labeling; Declaration of Free Glutamate in Food
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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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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002M-0295
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| Premarket Approval for Paragon CRT, Paragon Quadra RG, and
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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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| 2002P-0493
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| Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2003V-0042
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| Laser Light Show Projector
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0462
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| Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0416
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| Beverages: Bottled Water
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| 2004N-0503
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| 2004P-0339
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| Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)
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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 2004P-0472
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| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
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| 2004P-0506
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| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2004P-0551
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| ANADA Suitablity petition for Omeprazole tablet for Horses
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| 2005N-0010
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| High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
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| 2005P-0034
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| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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| 2005V-0052
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| Projector for a Laser Light Show
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| 2005V-0053
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| Projector for a Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C
242
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| Bayer HealthCare, LLC
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| Vol #:
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| 77
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| C 5
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| J. Neil
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| Vol #:
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| 3
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| 1986P-0224
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| LD50 ACUTE TOXICITY TEST
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| ANS 13
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| United States Senate
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| Vol #:
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| 3
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| C
72
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| National Confectioners Association (NCA) and Chocolate Manufacturers Assn (CMA)
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| Vol #:
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| 7
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| C
89
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| National Confectioners Assn (NCA) and Chocolate Manufacturers Assn (CMA)
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| Vol #:
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| 9
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
33
Attachment
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 37
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| 1996N-0244
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| Food Labeling; Declaration of Free Glutamate in Food
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|
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| C 614
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| R. Simmons
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| Vol #:
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| 17
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| C
82
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| Public Citizen and 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
80
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| Public Citizen and 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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|
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| C
79
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| Public Citizen and 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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| | | | | | | | |
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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|
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|
|
| C
241
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| Food Marketing Institute (FMI)
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| Vol #:
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| 28
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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|
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|
|
| C
366
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| Food Marketing Institute (FMI)
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| Vol #:
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| 30
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| |
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| 2002P-0493
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| Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)
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| PDN
1
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| HFD-001 to Andrx Pharmaceuticals Corp.
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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
39
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| Schering-Plough
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| Vol #:
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| 6
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| 2003P-0366
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| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
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| PDN
1
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| HFD-1 to Mattingly, Stanger & Malur, P.C.
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| Vol #:
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| 1
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 39
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| L. Kelly
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| Vol #:
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| 5
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| C
40
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| Public Citizen and Center for Food Safety
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| Vol #:
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| 5
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| 2003V-0042
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| Laser Light Show Projector
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| EXP
1
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| Laserwurx, LLC
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| Vol #:
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| 1
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| C
3
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| Bergen Community College (Bergen)
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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|
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| EMC
981
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| Ecological Society of the Philippines
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| Vol #:
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| 14
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| EMC 982
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| Number not used
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| Vol #:
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| 14
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| EMC 983
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| B Holmes
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| Vol #:
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| 14
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| EMC 984
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| H Lehman
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| Vol #:
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| 14
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| EMC 985
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| P Stone
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| Vol #:
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| 14
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| EMC 986
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| M Iluna
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| Vol #:
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| 14
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| EMC 987
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| B Lowe
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| Vol #:
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| 14
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| EMC 988
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| T Moody
|
| Vol #:
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| 14
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| EMC 989
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| C Thorsen
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| Vol #:
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| 14
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| EMC 990
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| T Jeffryes
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| Vol #:
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| 14
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|
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| EMC
991
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| We The People for Change
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| Vol #:
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| 14
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|
|
|
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| EMC 992
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| J Carr
|
| Vol #:
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| 14
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|
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| EMC 993
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| A Richards
|
| Vol #:
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| 14
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|
| | | | | | | | |
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| |
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| EMC
994
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| Kent State University
|
| Vol #:
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| 14
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|
|
|
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| EMC 995
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| N Steele
|
| Vol #:
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| 14
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|
|
|
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| EMC 996
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| V Roessler
|
| Vol #:
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| 14
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|
|
|
|
| EMC 997
|
| K Moore
|
| Vol #:
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| 14
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|
|
|
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| EMC 998
|
| C King
|
| Vol #:
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| 14
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|
|
|
|
| EMC 999
|
| S Thompson
|
| Vol #:
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| 14
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|
|
|
|
| EMC 1000
|
| S Freeman
|
| Vol #:
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| 14
|
|
|
|
|
| EMC 1001
|
| J McCoy
|
| Vol #:
|
| 14
|
|
|
|
|
| EMC 1002
|
| E Kravis
|
| Vol #:
|
| 14
|
|
|
|
|
| 2004D-0462
|
| Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
|
|
|
|
|
| C
2
|
| Duke University Medical Center
|
| Vol #:
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| 1
|
|
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|
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| C
3
|
| Hemosol
|
| Vol #:
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| 1
|
|
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|
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| C
4
Attachment
1, 2
|
| Health Research Associates (HRA)
|
| Vol #:
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| 1
|
|
|
|
|
| C
5
|
| Northfield Laboratories, Inc.
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0493
|
| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
|
|
|
|
|
| C
1
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
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| 1
|
|
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|
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| C
2
|
| GlaxoSmithKline (GSK)
|
| Vol #:
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| 1
|
|
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|
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| C
3
References
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| Merck & Co., Inc.
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0510
|
| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
|
|
|
|
|
| C
4
|
| William Atwood Lobster Company
|
| Vol #:
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| 1
|
|
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| C
5
|
| National Fisheries Institute (NFI)
|
| Vol #:
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| 1
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|
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|
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| C
6
|
| Garbo Lobster Company, Inc.
|
| Vol #:
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| 1
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|
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|
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| C
7
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| FinestKind Fish Market
|
| Vol #:
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| 1
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|
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|
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| C
8
|
| Ipswich Shellfish Co., Inc.
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| Vol #:
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| 1
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|
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|
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| C
9
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| Seatrade International, Inc.
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| Vol #:
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| 1
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| C
10
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| Boston Lobster Company
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| Vol #:
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| 1
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| C
11
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| Lobster Trap Co.
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| Vol #:
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| 1
|
|
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|
|
| C
12
|
| East Coast Seafood, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004G-0381
|
| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
| C
1
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
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| 1
|
|
|
|
|
| C
2
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
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| 1
|
|
|
|
|
| C
3
|
| International Foodservice Distributors Assn (IFDA)
|
| Vol #:
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| 1
|
|
|
|
|
| C
4
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
| | | | | | | | |
|
| |
|
| C 197
|
| A. Qamruddin
|
| Vol #:
|
| 23
|
|
|
|
|
| 2004N-0416
|
| Beverages: Bottled Water
|
|
|
|
|
| C
1
|
| American Beverage Association
|
| Vol #:
|
| 1
|
|
| |
|
| 2004N-0503
|
| Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
|
|
|
|
|
| C
1
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0516
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
|
|
|
|
|
| C
1
|
| Food Allergy & Anaphylaxis Network
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0559
|
| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
|
|
|
|
|
| C 2
|
| L. Babberl
|
| Vol #:
|
| 1
|
|
|
|
|
| C
3
|
| Stevens Johnson Syndrome Foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| C 4
|
| T. Schmitt
|
| Vol #:
|
| 1
|
|
|
|
|
| C 5
|
| B. Gemperline
|
| Vol #:
|
| 1
|
|
|
|
|
| C 6
|
| S. Russell
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0324
|
| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
|
|
|
| AMD
3
|
| Dey, L.P.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0339
|
| Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)
|
|
|
|
|
| LET
1
|
| HFD-005 to Frommer Lawrence & Haug, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0351
|
| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
|
|
|
|
|
| LET
1
|
| HFD-005 to STD Prevention and Control Service
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0411
|
| Compel Enforcement and Regulation of Amyl Nitrate
|
|
|
|
|
| C 2
|
| G. Austin
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
|
|
| SUP 2
|
| Noven Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0506
|
| fentanyl transdermal products reduce the potential for abuse of certain types of these products
|
|
|
|
|
| SUP 1
|
| Noven Pharmaceuticals, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004P-0520
|
| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
|
|
|
|
|
| C
2
|
| Dey, L.P. (Dey)
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0551
|
| ANADA Suitablity petition for Omeprazole tablet for Horses
|
|
|
|
|
| PAV
1
|
| HFV-100 to Intervet, Inc.
|
| Vol #:
|
| 1
|
|
