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| Dockets Entered
On May 27, 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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| 1999F-0719
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| Safe use Olestra in
place of Fats and Oils in Prepackaged
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| 2002H-0443
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| Civil Money Penalty
Re: LaHaye Ctr.for Advanced Eye Care
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| 2003H-0432
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| Civil Money Penalty,
Korangy Radiology Associates, PA
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| 2003N-0342
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| Toll-Free Number for
Reporting Adverse Events on Labeling for Human Drug Products
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| 2004M-0147
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| P890064/S009 - Digene
Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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| 2004N-0115
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| Prescription Drug Importation
Study
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| 2004P-0059
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| Health Claim Petition:
Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0060
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| Health Claim Petition:
Glucosamine Sulfate and Osteoarthritis
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| 2004P-0252
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| ANDA Suitability for
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/700 mg, 7.5
mg/700 mg, and 10 mg/700 mg
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| 2004Q-0097
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| Qualified Health Claim: Calcium
and various cancers
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| 2004Q-0144
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| Qualified Health Claim
(QHC): Chromium picolinate and Diabetes
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| 2004Q-0180
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| Qualified Health Claim
(QHC): Lutein and Eye Diseases
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
14001
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| Tabak's Health Products
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| Vol #:
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| 120
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| LET
14002
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14003
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14004
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14005
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14006
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| Nutritional specialties,
Inc.
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| Vol #:
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| 120
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| LET
14007
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14008
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14009
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14010
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14011
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14012
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| Nutritional Specialties,
Inc.
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| Vol #:
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| 120
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| LET
14013
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| Botanical Laboratories,
Inc.
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| Vol #:
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| 120
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| LET
14014
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| Purdue Products L.P.
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| Vol #:
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| 120
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| LET
14015
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| Synergy Worldwide
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| Vol #:
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| 120
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| LET
14016
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| Highland Laboratories
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| Vol #:
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| 120
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| LET
14017
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| Botanical Laboratories
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| Vol #:
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| 120
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| LET
14018
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| Innovative Hair Technology
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| Vol #:
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| 120
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| LET
14019
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| K & K Health Products
Inc.
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| Vol #:
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| 120
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| LET
14020
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| Nutriex, L.C.
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| Vol #:
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| 120
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| LET
14021
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| Nutriex, L.C.
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| Vol #:
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| 120
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| LET
14022
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| Herbalife International
of America, Inc.
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| Vol #:
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| 120
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| LET
14023
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| Herbalife International of America, Inc.
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| Vol #:
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| 120
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| LET
14024
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| Herbalife International of America, Inc.
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| Vol #:
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| 120
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| LET
14025
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| Now Foods
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| Vol #:
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| 120
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| LET
14026
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| Source Naturals
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| Vol #:
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| 120
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| LET
14027
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| Yerba Prima
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| Vol #:
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| 120
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| LET
14028
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| Nutrition Now, Inc.
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| Vol #:
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| 120
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| LET
14029
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| Cardio Tek LLC
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| Vol #:
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| 120
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| LET
14030
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| Neways, Inc.
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| Vol #:
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| 120
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| 1999F-0719
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| Safe use Olestra in place of Fats and Oils in Prepackaged
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| BKG
1
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| Background Material
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| Vol #:
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| 1
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| FONS
1
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| Findings of No Significant Impact
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| Vol #:
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| 1
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| CS 20
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| HFA-305
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| Vol #:
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| 1
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| OR 17
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| HF-3
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| Vol #:
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| 1
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| CS 7
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| HFA-305
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| Vol #:
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| 2
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| SD 1
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| HF-3
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| Vol #:
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| 2
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| EMC 1
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| S. Justin
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| Vol #:
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| 2
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| 2004M-0147
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| P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
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| CR
1
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| HFZ-402
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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| C
8
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| Hepatitis C Global Foundation
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| Vol #:
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| 11
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| C
9
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| Manhattan Institute for Policy Research
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| Vol #:
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| 12
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| C 10
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| consumer
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| Vol #:
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| 11
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| EC
43
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| Men's Health Network
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| Vol #:
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| 10
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| EC
44
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| National Association of Hispanic Nurses/Colorado
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| Vol #:
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| 10
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| EC
45
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| Florida Academy of Family Physicians
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| Vol #:
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| 10
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| EC
46
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| California Pharmacists Association
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| Vol #:
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| 10
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| EC
47
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| Mr. Aaron Berg
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| Vol #:
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| 10
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| EC
48
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| Dr. Ruby Martinez
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| Vol #:
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| 10
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| EC
49
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| greater boston diabetes society
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| Vol #:
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| 10
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| EC
50
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| Mrs. Sandra Frear
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| Vol #:
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| 10
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| EMC
15
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| Pfizer Inc
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| Vol #:
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| 10
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| EMC
16
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| European Association of Euro-Pharmaceutical Companies
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| Vol #:
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| 11
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| EMC
17
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| Canadian Internaitonal Pharmacy Association
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| Vol #:
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| 11
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| LET
4
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| Weider Nutrition International Inc
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| Vol #:
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| 13
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| LET
5
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| Weider Nutrition International Inc
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| Vol #:
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| 13
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| MT
1
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| FDA and Emord & Associates on behalf of Weider Nutrition
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| Vol #:
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| 13
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| SUP
5
References
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| Emord & Associates PC
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| Vol #:
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| 13
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| LET
7
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| Rotta Pharamceuticals Inc
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| Vol #:
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| 3
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| MT 1
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| FDA and Hogan and Hartson on behalf of Rotta Pharmaceuticals
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| Vol #:
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| 3
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| 2004P-0252
|
| ANDA Suitability for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/700 mg, 7.5 mg/700 mg, and 10 mg/700 mg
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment A,
B, C
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| Lachman Consultant Services, 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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| EC
1
Attachment
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| Harvard Medical School
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| Vol #:
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| 15
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| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| C
1
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| C Leigh Broadhurst PhD
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| Vol #:
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| 11
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| LET
1
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| Nutrtion 21 Inc
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| Vol #:
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| 11
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| LET 2
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| Emord & Associates PC
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| Vol #:
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| 11
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| 2004Q-0180
|
| Qualified Health Claim (QHC): Lutein and Eye Diseases
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| ACK
2
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| HFS-200 to AAC Consulting Group
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| Vol #:
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| 5
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