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| Dockets Entered
On February 20, 2004
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXIODS
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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| 2000P-1499
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| Remove alosetron (Lotronex) from the market
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| 2001P-0169
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| Access & Safe Distribution of Alosetron
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| 2002P-0292
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| Health Claims: Walnuts & Cornary Disease
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| 2003M-0462
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| Premarket Approval, BP 000023/0, MedMira Reveal Rapid HIV-1 Antibody Test
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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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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| 2003Q-0559
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| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| 2004P-0043
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| Require Purdue Pharma to revise labeling of OxyContin Tablets
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| 2004Q-0072
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| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
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| 2004V-0030
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| Projector for a Laser Light Show
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| 1980N-0208
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| BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXIODS
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| NCR
2
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| FDA
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| Vol #:
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| 3
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12751
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| Lane Labs USA, Inc.
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| Vol #:
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| 104
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| LET
12752
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| Lane Labs USA, Inc.
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| Vol #:
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| 104
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| LET
12753
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| Lane Labs USA, Inc.
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| Vol #:
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| 104
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| LET
12754
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| Lane Labs USA, Inc.
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| Vol #:
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| 104
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| LET
12755
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| Lan Labs USA,Inc.
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| Vol #:
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| 104
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| LET
12756
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| Twin Laboratories Inc.
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| Vol #:
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| 104
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| LET
12757
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| Twin Laboratories Inc.
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| Vol #:
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| 104
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| LET
12758
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| Twin Laboratories Inc.
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| Vol #:
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| 104
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| LET
12759
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| NBTY Inc.
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| Vol #:
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| 104
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| LET
12760
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| NBTY Inc.
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| Vol #:
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| 104
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| LET
12761
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| Leiner Health Products
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| Vol #:
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| 104
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| LET
12799
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| NBTY Inc.
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| Vol #:
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| 104
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| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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| C
3
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| Fresenius Medical Care NA
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| Vol #:
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| 1
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| EMC
1
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2000P-1499
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| Remove alosetron (Lotronex) from the market
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| ANS
1
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| HFD-1 to Public Citizen's Health Research Group
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| Vol #:
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| 5
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| 2001P-0169
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| Access & Safe Distribution of Alosetron
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| PAV
1
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| HFD-1 to Lotronex Action Group
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| Vol #:
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| 3
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| 2002P-0292
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| Health Claims: Walnuts & Cornary Disease
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| MM
5
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| Meeting between California Walnut Commission, Rose Research Marketing & FDA
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| Vol #:
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| 6
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| C
12
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| Blue Diamond Growers
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| Vol #:
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| 5
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| C 66
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| K M
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| Vol #:
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| 5
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| C 67
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| K Moncrief
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| Vol #:
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| 5
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| EMC
10
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| Bayer Healthcare AG
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| Vol #:
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| 2
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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| LET
1
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| Hercules Incorporated
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| Vol #:
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| 1
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| 2003M-0462
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| Premarket Approval, BP 000023/0, MedMira Reveal Rapid HIV-1 Antibody Test
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| AAV
1
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| MedMira Laboratories Inc
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| Vol #:
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| 1
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| EMC 24
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| F Weigert
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| Vol #:
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| 3
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| C
10
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| Herbalife International of America Inc
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| Vol #:
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| 2
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| C
11
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| Solae LLC
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| Vol #:
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| 2
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| C
12
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| America Academy of Pediatrics
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| Vol #:
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| 2
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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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| C
9
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| Teva Pharmaceuticals USA Inc
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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
18
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| America's Hearing Healthcare Team
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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
7
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| America's Hearing Healthcare Team
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| Vol #:
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| 1
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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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| C
2
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| ItalFoods Inc
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| Vol #:
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| 5
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| C
3
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| University of Buffalo
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| Vol #:
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| 5
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| C 4
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| P Gawdun RD
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| Vol #:
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| 5
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| C 3
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| S Bell
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| Vol #:
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| 2
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| 2004P-0043
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| Require Purdue Pharma to revise labeling of OxyContin Tablets
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| C 1
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| S Bell
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| Vol #:
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| 3
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| LET
1
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| Purdue Pharma LP
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| Vol #:
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| 3
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| 2004Q-0072
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| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
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| ACK
1
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| HFS-830 to AAC Consulting Group
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| Vol #:
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| 4
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| LET
1
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| HFS-200 to AAC Consulting Group
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| Vol #:
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| 4
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| QHC
1
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| Belova Inc
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| Vol #:
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| 1
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| SUP
1
References
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| Belovo Inc
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| Vol #:
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| 4
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| 2004V-0030
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| Projector for a Laser Light Show
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| VRA
1
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| HFZ-300 to HB Stereo Inc
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| Vol #:
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| 1
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