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| Dockets Entered
On November 12, 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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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2003P-0365
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| Galderma
product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922
can be formulated as a topical solution with the substitution of Hydroquinone
at 4% for the 2% mequinol as an ANDA
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| 2003P-0555
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| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
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| 2004D-0377
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| International Conference on
Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs
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| 2004D-0378
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| International Conference on
Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the
Potential for Delayed Ventricular Repolarization (QT Interval Prolongation)
by Human Pharmaceuticals
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| 2004D-0443
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| Guidance for Industry on Quality
Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004M-0495
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| P020021 - Wizard X-Cell
Photodynamic Therapy Balloon with Fiber Optic Diffuser, Approved 8/1/03
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| 2004M-0496
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| P040022 - EVS Vascular
Closure System, Approved 11/3/04
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| 2004M-0497
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| P030031 - Biosense
Webster NaviStar/Celsius ThermoCool Diagnostic/Ablation Deflectable
Tip Catheters, Approved 11/5/04
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| 2004N-0355
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| Scientific Considerations
Related to Developing Follow-on Protein Products
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| 2004N-0454
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| Dietary Supplements; Premarket
Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004P-0349
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| Action on Products containing
added Mercury
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| 2004P-0504
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| ANDA for DiaBeta (glyburide)
Tablets, 5 mg
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| 2004Q-0144
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| Qualified Health Claim (QHC):
Chromium picolinate and Diabetes
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| 2004S-0233
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| Stimulating Innovation
in Medical Technologies
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
14740
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| Fitness Labs Nutrition
Corporation
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| Vol #:
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| 129
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| LET
14741
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| Fitness Labs Nutrition
Corporation
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| Vol #:
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| 129
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| LET
14742
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| Fitness Nutrition
Corporation
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| Vol #:
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| 129
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| LET
14743
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| Fitness Labs Nutrition
Corporation
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| Vol #:
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| 129
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| LET
14744
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| Fitness Labs Nutrition
Corporation
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| Vol #:
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| 129
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| 2001P-0075
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| Switch Status of
Emergency Contraceptives from Rx to OTC
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| EC 823
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| Ms. julie smith
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| Vol #:
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| 163
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| 2003P-0365
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| Galderma
product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922
can be formulated as a topical solution with the substitution of Hydroquinone
at 4% for the 2% mequinol as an ANDA
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| LET
3
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| Jerussi Consulting,
Inc.
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| Vol #:
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| 1
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| 2003P-0555
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| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
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| C 25
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| R. Jones
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| Vol #:
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| 2
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| 2004D-0377
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| International
Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation
of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs
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|
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| EC
2
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| ChanTest, Inc.
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| Vol #:
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| 1
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| EC
3
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| ChanTest, Inc.
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| Vol #:
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| 1
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| 2004D-0378
|
| International
Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation
of the Potential for Delayed Ventricular Repolarization (QT Interval
Prolongation) by Human Pharmaceuticals
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|
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| EC
1
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| ChanTest, Inc.
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| Vol #:
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| 1
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| 2004D-0443
|
| Guidance for Industry
on Quality Systems Approach to Pharmaceutical Current Good Manufacturing
Regulations
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|
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|
|
| EC
2
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| F. Hoffmann-La Roche
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| Vol #:
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| 1
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| 2004M-0495
|
| P020021 - Wizard
X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser, Approved
8/1/03
|
|
| | | | | | | | |
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| |
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| AAV
1
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| Axcan Scandipharm, Inc.
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| Vol #:
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| 1
|
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| 2004M-0496
|
| P040022 - EVS Vascular Closure System, Approved 11/3/04
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|
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| AAV
1
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| angioLink Corporation
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| Vol #:
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| 1
|
|
| |
|
| 2004M-0497
|
| P030031 - Biosense Webster NaviStar/Celsius ThermoCool Diagnostic/Ablation Deflectable Tip Catheters, Approved 11/5/04
|
|
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| AAV
1
|
| Biosense Webster, Inc.
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| Vol #:
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| 1
|
|
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|
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| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
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|
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|
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| C
2
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| Genentech, Inc.
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| Vol #:
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| 1
|
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| EC
10
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| Rakoczy Molino Mazzochi Siwik LLP
|
| Vol #:
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| 1
|
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| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| EC 29
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| Dr. Sue Hudson
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| Vol #:
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| 1
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| EC 30
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| Ms. Pauline Hattemer
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| Vol #:
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| 1
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| EC 31
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| Mrs. Lacretia C Ballance
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| Vol #:
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| 1
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| EC 32
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| Mrs. Susan Stewart
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| Vol #:
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| 1
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| EC 33
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| Mrs. Nancy Hawks
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| Vol #:
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| 1
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| EC 34
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| Mrs. Maureen Braun
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| Vol #:
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| 1
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| EC 35
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| Mr. Homer Ailstock
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| Vol #:
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| 1
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| EC 36
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| Miss. mary ladue
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| Vol #:
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| 1
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| EC 37
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| Ms. John Mahler
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| Vol #:
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| 1
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| EC 38
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| Ms. Sandra Simmons
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| Vol #:
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| 1
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| EC 39
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| Ms. Betty Jenkins
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| Vol #:
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| 1
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| EC 40
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| Management Consultants
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| Vol #:
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| 1
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| EC 41
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| Ms. carol nye
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| Vol #:
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| 1
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| EC 42
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| Ms. Doris Whitney
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| Vol #:
|
| 1
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| EC 43
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| Ms. tobie GREENBERG
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| Vol #:
|
| 1
|
|
|
|
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| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| EC 22
|
| Autism Healing Network
|
| Vol #:
|
| 1
|
|
|
|
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| 2004P-0504
|
| ANDA for DiaBeta (glyburide) Tablets, 5 mg
|
|
|
|
|
| ACK 1
|
| HFA-305 to Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
|
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|
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| CP
1
|
| Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
|
|
|
|
|
| SUP
1
Attachment
|
| Nutrtion 21, Inc
|
| Vol #:
|
| 11
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
