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| Dockets Entered
On March 18, 2004
Table of Contents
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| Docket #
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| Title
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| 1991P-0446
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| Amend Regulation Regarding Designation of Ingredients
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| 1996P-0347
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| International Cosmetic Ingredient Dictionary - Harmonization
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| 1998P-0504
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| Raw Molluscan Shellfish of Undetectable Levels
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002P-0406
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| ANDA Suitability for Amoxicillin & Clavulanate Potassium
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| 2002P-0414
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| Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA
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| 2002P-0444
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| cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| 2003N-0338
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| Obesity
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0276
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| Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004N-0033
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| Factor VIII Inhibitors
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004P-0061
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| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2004V-0029
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| Laser Light Show
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| 1991P-0446
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| Amend Regulation Regarding Designation of Ingredients
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| WDL
1
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| Cosmetic, Toiletry, and Fragrance Assn (CFTA)
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| Vol #:
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| 1
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| 1996P-0347
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| International Cosmetic Ingredient Dictionary - Harmonization
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| WDL
1
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| Cosmetic, Toiletry, and Fragrance Assn (CTFA)
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| Vol #:
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| 1
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| C 830
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| T. McGuire
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| Vol #:
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| 32
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| C 831
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| D. Harris
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| Vol #:
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| 32
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| C 832
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| N. Jamieson
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| Vol #:
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| 32
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| C 833
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| E. Seitz
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| Vol #:
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| 32
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| C 834
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| L. Brown
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| Vol #:
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| 32
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| C 835
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| E. Bennett
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| Vol #:
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| 32
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| SUP
6
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 2
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| SUP
4
Tab 1,
Tab 2
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| Hyman, Phelps & McNamara
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| Vol #:
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| 3
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 62
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| N. Martinez
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| Vol #:
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| 6
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| C 63
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| W. Reece
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| Vol #:
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| 6
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| 2003P-0276
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| Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
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| C 3
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| T. McGuire
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| Vol #:
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| 1
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| C 4
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| D. Harris
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| Vol #:
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| 1
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| C 5
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| N. Jamieson
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| Vol #:
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| 1
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| C 6
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| E. Seitz
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| Vol #:
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| 1
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| C 7
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| L. Brown
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| Vol #:
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| 1
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| C 8
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| E. Bennett
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| Vol #:
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| 1
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| C 9
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| D. Berghorst
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| Vol #:
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| 1
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| C 10
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| R. Bergman
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| Vol #:
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| 1
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| C 11
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| A. Shannon
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| Vol #:
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| 1
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| C 12
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| R. Duffy
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| Vol #:
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| 1
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| C 13
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| D. Driscoll
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| Vol #:
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| 1
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| C 14
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| S. Pastin
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| Vol #:
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| 1
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| C 15
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| E. Solano
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| Vol #:
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| 1
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| C 16
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| R. Michele
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| Vol #:
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| 1
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| C 17
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| J. Burgess
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| Vol #:
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| 1
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| C 18
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| D. Hurst
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| Vol #:
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| 1
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| C 19
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| E.L. Gilbert
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| Vol #:
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| 1
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| RC
2
Tab 1, Tab
2
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| Valeant Pharmaceuticals International
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| Vol #:
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| 3
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| SUP
5
Tab 1, Tab
2
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| Hyman, Phelps & McNamara
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| Vol #:
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| 3
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| C
3
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| Command Trust Newtwork, Inc.
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| Vol #:
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| 1
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| C 27
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| M. Condon
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| Vol #:
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| 1
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| 2004N-0033
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| Factor VIII Inhibitors
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| C
2
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| Bayer HealthCare LLC (Bayer)
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| Vol #:
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| 4
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C
1
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| Cosmetic, Toiletry, and Fragrance Assn (CTFA)
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| Vol #:
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| 1
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| C
2
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| The Soap and Detergent Assn (SDA)
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| Vol #:
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| 1
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| 2004P-0061
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| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
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| C
1
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| Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| ACK
1
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| HFS-830 to Fleminger, Inc
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| Vol #:
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| 8
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| QHC
1
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| Fleminger, Inc
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| Vol #:
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| 1
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| SUP
1
References
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| Fleminger, Inc
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| Vol #:
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| 8
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| 2004V-0029
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Club La Vela
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| Vol #:
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| 1
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