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| Dockets Entered
On November 4, 2004
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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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1409
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| Revision of the Identification of the Ionotophoresis
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003Q-0559
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| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0376
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| ANADA for a feneric intravaginal progesterone insert for cattle that differs from the pioneer product
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| 2004Q-0100
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| Qualified Health Claim: Calcium and bone fractures
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C 241
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| T. Tiedt, PhD
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| Vol #:
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| 77
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14660
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| Source Naturals
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| Vol #:
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| 128
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| LET
14661
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| Source Naturals
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| Vol #:
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| 128
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| LET
14662
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| Nature's Way Products, Inc.
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| Vol #:
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| 128
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| 2000N-1409
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| Revision of the Identification of the Ionotophoresis
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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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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 675
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| Bayer Corporation
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| Vol #:
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| 460
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| EXB 676
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| Bayer Corporation
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| Vol #:
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| 460
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| EXB 677
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| Bayer Corporation
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| Vol #:
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| 460
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| EXB 678
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| Bayer Corporation
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| Vol #:
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| 460
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| EXB 679
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| Bayer Corporation
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| Vol #:
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| 460
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| EXB 680
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| Bayer Corporation
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| Vol #:
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| 460
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| 2003Q-0559
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| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
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| ANS
1
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| HFS-001 to North American Olive Oil Assn
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| Vol #:
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| 9
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| C
16
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| California Avocado Commission
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| Vol #:
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| 5
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| LET
7
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| North American Olive Oil Assn
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| Vol #:
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| 5
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| LET
8
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| North American Olive Oil Assn
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| Vol #:
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| 5
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| LET 9
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| Number Not Used
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| Vol #:
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| 5
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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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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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| SUP
1
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| Public Citizen
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| CR
1
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| Children HAving Advocates Against Mercury Poisoning (CHAMP)
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| Vol #:
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| 1
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| 2004P-0376
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| ANADA for a feneric intravaginal progesterone insert for cattle that differs from the pioneer product
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| PAV
1
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| HFV-100 to Bioniche Animal Health USA, Inc.
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| Vol #:
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| 1
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| LET
5
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| Marine Bio Co., Ltd
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| Vol #:
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| 15
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| LET
7
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| Marine Bio Co., Ltd
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| Vol #:
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| 9
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| LET
5
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| Marine Bio Co., Ltd
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| Vol #:
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| 4
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| 2004Q-0100
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| Qualified Health Claim: Calcium and bone fractures
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| LET
5
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| Marine Bio Co., Ltd
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| Vol #:
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| 6
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| LET
5
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| Marine Bio CO., Ltd.
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| Vol #:
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| 6
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