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| Dockets Entered
On December 13, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| 2005C-0482
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| Color Additive Petition to Expand the Use of Sodium Copper Chlorophyllin to Include Foods Generally (with the Exception of Meat, Poultry, Fish, and Standardized Foods) and to Include Fescue Grass as a
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| 2005N-0077
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| Color Additive Certification; Increase in Fees for Certification Services
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0393
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005N-0448
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| Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0400
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| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| 2005P-0408
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| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17017
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| Jarrow Formulas
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| Vol #:
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| 154
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| LET
17018
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| Futurebiotics LLC
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| Vol #:
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| 154
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| LET
17019
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| Futurebiotics LLC
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| Vol #:
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| 154
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| LET
17020
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| Futurebiotics LLC
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| Vol #:
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| 154
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| LET
17021
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| Futurebiotics LLC
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| Vol #:
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| 154
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| LET
17022
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| Nature's Healing Solutions, Inc.
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| Vol #:
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| 154
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| LET
17023
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17024
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17025
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17026
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17027
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17028
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17029
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| Hillestad Pharmaceuticals
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| Vol #:
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| 154
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| LET
17030
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| AdvoCare International, L.P.
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| Vol #:
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| 154
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| EC
4
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| Mr. Corry Elliott
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| Vol #:
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| 1
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| EC
5
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| Mr. Daniel Nieliwocki
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| Vol #:
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| 1
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| EC
6
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| Miss. L. Vazquez
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| Vol #:
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| 1
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| EC
7
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| Mrs. Lisa Carroll
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| Vol #:
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| 1
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| EC
8
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| Ananda Ashram
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| Vol #:
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| 1
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| EC
9
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| Ms. Terry Lowe
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| Vol #:
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| 1
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| EC
10
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| Ms. Barb Claude
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| Vol #:
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| 1
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| EC
11
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| Ms. DC Small
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EC
164
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| Mrs. Lizza Reed Galvan
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| Vol #:
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| 34
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| EC
10
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| Mr. Corry Elliott
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| Vol #:
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| 1
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| EC
11
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| Mrs. Katherine Johns Kaplan
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| Vol #:
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| 1
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| EC
12
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| Mr. Jim Guenther
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| Vol #:
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| 1
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| EC
13
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| Mr. Thomas Kramer
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| Vol #:
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| 1
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| EC
14
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| Mr. Mark Clark
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| Vol #:
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| 1
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| EC
15
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| Mr. Dustain Ebaugh
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| Vol #:
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| 1
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| EC
16
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| Mr. James scherer
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| Vol #:
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| 1
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| EC
17
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| Mr. michael lay
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| Vol #:
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| 1
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| EC
18
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| Mrs. Jennifer Hast
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| Vol #:
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| 1
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| EC
19
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| Mr. John McEntee
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| Vol #:
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| 1
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| EC
20
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| Mr. Charles Buzbee
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| Vol #:
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| 1
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| EC
21
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| Mrs. Lisa Carroll
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| Vol #:
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| 1
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| EC
22
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| Ms. Barb Claude
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| Vol #:
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| 1
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| EC
23
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| Ms. Patricia Pennant
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| Vol #:
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| 1
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| EC
24
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| Mrs. robin voigt
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| Vol #:
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| 1
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| EC
25
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| Mr. Alex Eulenberg
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| Vol #:
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| 1
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| C 1
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| M. Harney, Jr.
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| Vol #:
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| 1
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| SUP 5
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| Mutual Pharmaceutical Co., Inc. (Mutual)
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| Vol #:
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| 5
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| LET
2
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| Hill Dermaceuticals, Inc.
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| Vol #:
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| 1
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| 2005C-0482
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| Color Additive Petition to Expand the Use of Sodium Copper Chlorophyllin to Include Foods Generally (with the Exception of Meat, Poultry, Fish, and Standardized Foods) and to Include Fescue Grass as a
|
|
|
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| NFL
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0077
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| Color Additive Certification; Increase in Fees for Certification Services
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| LET
1
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| International Association Color Manufacturers (IACM)
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| Vol #:
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| 1
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| C
1
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| Land O' Lakes Purina Feed, LLC (LOLPF)
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| Vol #:
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| 1
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| C
2
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| American Zoo and Aquarium Association (AZA)
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| Vol #:
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| 1
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| EXT
2
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| American Veterinary Medical Association (AVMA)
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EC
388
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| Mr. David Bogema
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| Vol #:
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| 5
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| EC
389
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| Ocean Wings
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| Vol #:
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| 5
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| EC
390
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| Ms. LAURA POULIN
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| Vol #:
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| 5
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| EC
391
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| Mr. daniel fish
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| Vol #:
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| 5
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| 2005N-0393
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
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| EC
1
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| Dr. Michelle Tallin
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| Vol #:
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| 1
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| TS
10
Attachment
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| California Walnut Commission
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| Vol #:
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| 2
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| 2005N-0448
|
| Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph
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|
|
|
|
| BKG 1
|
| BACKGROUND
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| Vol #:
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| 2
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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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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| N
1
|
| FDA
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| Vol #:
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| 1
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| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| EC
183
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| Berks Center for Digestive Health
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| Vol #:
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| 3
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| EC
184
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| Dr. Zev Wachtel
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| Vol #:
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| 3
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| 2005P-0400
|
| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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|
|
|
|
| EC
2
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
|
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| 2005P-0408
|
| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
|
|
|
|
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| EC
1
|
| Ms. Barb Claude
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| Vol #:
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| 1
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