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| Dockets Entered
On February 18, 2004
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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| 1998D-0834
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| Non-Contraceptive Estrogen Class Labeling
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2003D-0545
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| Questions and Answers Regarding Registration of Food Facilities
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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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-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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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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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12712
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12713
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12714
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12715
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12716
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12717
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| NBTY Inc.
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| Vol #:
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| 103
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| LET
12718
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| Synergy Worldwide
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| Vol #:
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| 103
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| LET
12719
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| Pharmavite LLC
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| Vol #:
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| 103
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| LET
12720
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| Nature's Sunshine Products, Inc.
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| Vol #:
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| 103
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| LET
12721
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| PhytoPharmica Natural Medicnes
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| Vol #:
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| 103
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| LET
12722
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 103
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| 1998D-0834
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| Non-Contraceptive Estrogen Class Labeling
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| GDL
4
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| Guidance
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| Vol #:
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| 6
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| NAD
4
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| FDA
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| Vol #:
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| 6
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C
71
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| Wisconsin Center for Dairy Research
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| Vol #:
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| 2
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| 2003D-0545
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| Questions and Answers Regarding Registration of Food Facilities
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| GDL
3
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| | | | | | | | |
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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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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| C
9
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| Federal Trade Commission
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| Vol #:
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| 6
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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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| LET
3
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| Valeant Pharmaceuticals International
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| Vol #:
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| 3
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| C
16
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| Audiology Foundation of America (AFA)
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| Vol #:
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| 2
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| C
17
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| Hearing Industries Assn (HIA)
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| Vol #:
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| 2
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| C
6
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| Audiology Foundation of America (AFA)
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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 16
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| M. Curtis
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| Vol #:
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| 1
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| C 17
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| J. Alexander
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| Vol #:
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| 1
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| C 18
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| M. Clifton
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| Vol #:
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| 1
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| C
19
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| Churches Center for Land and People
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| Vol #:
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| 1
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| ACK 1
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| HFA-305 to Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP
1
Tab
1, 2, 3,
4, 5, 6
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| Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| ACK 1
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| HFA-305 to Mylan Pharmaceuticals Inc.
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| Vol #:
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| 1
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| CP
1
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| Mylan Pharmaceuticals Inc.
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| Vol #:
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| 1
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