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| Dockets Entered
On April 14, 2005
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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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| |
|
|
| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| |
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0144
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| ANDA Suitability for Oxycodone Hydrochloride 20 mg/mL Oral Solution
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
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| 2005V-0145
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| Laser Light Show
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| C
35
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| Department of Defense
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| Vol #:
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| 149
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| C
36
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| Department of the Army
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| Vol #:
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| 150
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| C
37
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| Department of the Army
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| Vol #:
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| 151
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| C
38
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| Department of the Army
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| Vol #:
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| 152
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| |
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| EMC 108
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| No signature
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| Vol #:
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| 143
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| |
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| EMC 109
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| No signature
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| Vol #:
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| 143
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| |
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| EMC 110
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| No signature
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| Vol #:
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| 143
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| EMC 111
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| J. Erwin, DVM
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| Vol #:
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| 143
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| EMC 112
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| R. Zambrano
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| Vol #:
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| 143
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| EMC 113
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| T. Ball
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| Vol #:
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| 143
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| EMC 114
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| P. Zeilman
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| Vol #:
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| 143
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| |
|
|
| EMC 115
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| B. Priester
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| Vol #:
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| 143
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| EMC 116
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| MSgt G. Collins
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| Vol #:
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| 143
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| |
|
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| EMC 117
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| S. Jensen
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| Vol #:
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| 143
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|
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| EMC 118
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| No signature
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| Vol #:
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| 143
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| |
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| EMC 119
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| No signature
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| Vol #:
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| 143
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| EMC
120
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| R. Dingle and T. Rempfer
|
| Vol #:
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| 143
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| EMC
121
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| R. Dingle and T. Rempfer
|
| Vol #:
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| 143
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|
|
| EMC 122
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| R. Dingle and T. Rempfer
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| Vol #:
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| 143
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| |
|
|
| EMC 123
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| R. Fields, Sr.
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| Vol #:
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| 143
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| |
|
|
| EMC 124
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| L. Hernandez
|
| Vol #:
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| 143
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| |
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| EMC 125
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| A. Yurko
|
| Vol #:
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| 143
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|
| | | | | | | | |
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| |
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
15910
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| North American Pharmacal Inc.
|
| Vol #:
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| 140
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| |
|
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| LET
15911
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| North American Pharmacal Inc.
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| Vol #:
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| 140
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| |
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| LET
15912
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| Bradley Pharmaceuticals, Inc.
|
| Vol #:
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| 141
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| |
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| LET
15913
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| Arise & Shine Herbal Products, Inc.
|
| Vol #:
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| 141
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| |
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|
| LET
15914
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| Strauss Herb Company
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| Vol #:
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| 141
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| |
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| LET
15915
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| Pharmavite LLC
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| Vol #:
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| 142
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| |
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|
| LET
15916
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| Perrigo Company of South Carolina
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| Vol #:
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| 141
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| |
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| LET
15917
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| Perrigo Company of South Carolina
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| Vol #:
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| 141
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| |
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| LET
15918
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| Pure Encapsulations
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| Vol #:
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| 141
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| |
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| LET
15919
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| Advocare International, L.P.
|
| Vol #:
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| 141
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| |
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|
| LET
15920
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| Enzymatic Therapy
|
| Vol #:
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| 141
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| |
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| LET
15921
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15922
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| MOM Enterprise, Inc.
|
| Vol #:
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| 141
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| |
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| LET
15923
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15924
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| Window Rock Enterprises, Inc.
|
| Vol #:
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| 141
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| |
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| LET
15925
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| Window Rock Enterprises, Inc.
|
| Vol #:
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| 141
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| LET
15926
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| Window Rock Enterprises, Inc.
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| Vol #:
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| 141
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| LET
15927
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| Enzymatic Therapy
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| Vol #:
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| 141
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| LET
15928
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15929
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| Nutriex, L.C.
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| Vol #:
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| 141
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| LET
15930
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| Nutriex, L.C.
|
| Vol #:
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| 141
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| |
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| LET
15931
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15932
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| Enzymatic Therapy
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| Vol #:
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| 141
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| LET
15933
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| Enzymatic Therapy
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| Vol #:
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| 141
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| LET
15934
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| Enzymatic Therapy
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| Vol #:
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| 141
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| LET
15935
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15936
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15937
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15938
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15939
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15940
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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| LET
15941
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| Enzymatic Therapy
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| Vol #:
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| 141
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| |
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|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
| |
|
|
| MO
6
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| GCF-1
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| Vol #:
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| 1
|
| |
|
|
| 2004N-0456
|
| Serving Sizes of Products
that Can Reasonably be Consumed at One Eating Occasion; Updating of
Reference Amounts Customarily Consumed; Approaches for Recommending
Smaller Portion Sizes
|
|
| | | | | | | | |
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| EMC 26
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| J. Metcalf
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| Vol #:
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| 3
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| |
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| EMC 27
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| P. Carlsen
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| Vol #:
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| 3
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| |
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| EMC 28
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| C. Smith
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| Vol #:
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| 3
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| EMC 29
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| L. Graziano
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| Vol #:
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| 3
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| EMC 30
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| E. Souza
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| Vol #:
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| 3
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| EMC 31
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| P. Carlsen
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| Vol #:
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| 3
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| EMC 32
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| J. Buberel
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| Vol #:
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| 3
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| EMC 33
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| Gayle Topolinicki
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| Vol #:
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| 3
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| EMC 34
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| A. Moore
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| Vol #:
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| 3
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| EMC 35
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| M. Williams
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| Vol #:
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| 3
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| EMC 36
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| Kristin
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| Vol #:
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| 3
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| EMC 37
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| K. Baber
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| Vol #:
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| 3
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| EMC 38
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| L. Barbosa
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| Vol #:
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| 3
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| EMC 39
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| unsign
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| Vol #:
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| 3
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| EMC 40
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| A. Nowak
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| Vol #:
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| 3
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| EMC 41
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| S. Rosso
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| Vol #:
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| 3
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| EMC 42
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| L. Poindexter
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| Vol #:
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| 3
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| EMC 43
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| D. Brown
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| Vol #:
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| 3
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| EMC 44
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| E. Peterson
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| Vol #:
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| 3
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| EMC 45
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| unsign
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| Vol #:
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| 3
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| EMC 46
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| S. Virgilio
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| Vol #:
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| 3
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| EMC 47
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| C. Ebbinghaus
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| Vol #:
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| 3
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| EMC 48
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| F. Wagle
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| Vol #:
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| 3
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| EMC 49
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| M. Gebhardt
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| Vol #:
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| 3
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| EMC 50
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| T. Cook
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| Vol #:
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| 3
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| |
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| EMC 51
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| D. Holmwood
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| Vol #:
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| 3
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| EMC 52
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| R & C. Webster
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| Vol #:
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| 3
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| EMC 53
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| B. Middleton
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| Vol #:
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| 3
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| |
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| EMC 54
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| L. Mallon
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| Vol #:
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| 3
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| |
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| EMC 55
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| unsign
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| Vol #:
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| 3
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| |
|
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| EMC 56
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| R. Smistik
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| Vol #:
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| 3
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| |
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| EMC 57
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| G.Oliver
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| Vol #:
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| 3
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| |
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| EMC 58
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| F. Prevo
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| Vol #:
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| 3
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| |
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| EMC 59
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| L. Kelly
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| Vol #:
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| 3
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| |
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| EMC 60
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| T. Carey
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| Vol #:
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| 3
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| | | | | | | |
| |
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| EMC 61
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| S. Johnson
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| Vol #:
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| 3
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| |
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| EMC 62
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| K. Ensfield
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| Vol #:
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| 3
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| |
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| EMC 63
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| J. Davis
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| Vol #:
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| 3
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| |
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| EMC 64
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| L. Rodwell
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| Vol #:
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| 3
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| EMC 65
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| P. Gati
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| Vol #:
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| 3
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| EMC 66
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| N. Comstock
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| Vol #:
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| 3
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| EMC 67
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| O.Resca
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| Vol #:
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| 3
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| |
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| EMC 68
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| R. Wright
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| Vol #:
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| 3
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| |
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| EMC 69
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| F. Bicknell
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| Vol #:
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| 3
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| EMC 70
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| K. Putnam
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| Vol #:
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| 3
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| EMC 71
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| D. Brandon
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| Vol #:
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| 3
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| |
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| EMC 72
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| Alan/Donna
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| Vol #:
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| 3
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| |
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| EMC 73
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| M. Watson
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| Vol #:
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| 3
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| |
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| EMC 74
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| A. Russin
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| Vol #:
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| 3
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| |
|
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| EMC 75
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| unsign
|
| Vol #:
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| 3
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| |
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| EMC 76
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| R. Felix
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| Vol #:
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| 3
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| |
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| EMC 77
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| J. Blanchard
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| Vol #:
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| 3
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| |
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| EMC 78
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| A. O'Connor
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| Vol #:
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| 3
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| |
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| EMC 79
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| T. Ey
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| Vol #:
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| 3
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| |
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| EMC 80
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| M. Beth
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| Vol #:
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| 3
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| |
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| EMC 81
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| J. Shafer
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| Vol #:
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| 3
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| |
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| EMC 82
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| M. Huang
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| Vol #:
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| 3
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| |
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| EMC 83
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| N. Grinvald
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| Vol #:
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| 3
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| |
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| EMC 84
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| A. Papale
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| Vol #:
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| 3
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| |
|
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| EMC 85
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| J. Barlow
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| Vol #:
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| 3
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| |
|
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| EMC 86
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| S. Boots
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| Vol #:
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| 3
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| |
|
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| EMC 87
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| J. Hanks
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| Vol #:
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| 3
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| |
|
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| EMC 88
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| D. Lauer
|
| Vol #:
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| 3
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| |
|
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| EMC 89
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| C. McQuown
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| Vol #:
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| 3
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| |
|
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| EMC 90
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| R. Kinsey
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| Vol #:
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| 3
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| |
|
|
| EMC 91
|
| S. Whitlow
|
| Vol #:
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| 3
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| |
|
|
| EMC 92
|
| A. Cox
|
| Vol #:
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| 3
|
| |
|
|
| EMC 93
|
| unsign
|
| Vol #:
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| 3
|
| |
|
|
| EMC 94
|
| C. Devitt
|
| Vol #:
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| 3
|
| |
|
|
| EMC 95
|
| K. Macy
|
| Vol #:
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| 3
|
| |
|
|
| EMC 96
|
| V. Watkins
|
| Vol #:
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| 3
|
| |
|
|
| EMC 97
|
| unsign
|
| Vol #:
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| 3
|
|
| | | | | | | | |
| |
|
|
| EMC 98
|
| unsign
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 99
|
| M. Washburn
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 100
|
| B. Fowler
|
| Vol #:
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| 3
|
| |
|
|
| EMC 101
|
| J. Nerlinger
|
| Vol #:
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| 3
|
| |
|
|
| EMC 102
|
| unsign
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 103
|
| B.Miller
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 104
|
| S. Wimberly
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 105
|
| J. Nerlinger
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 106
|
| unsign
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 107
|
| unsign
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 108
|
| unsign
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 109
|
| A. Albrecht
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
110
|
| E. Geefay Productions
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 111
|
| C. McKeon
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 112
|
| J. Ecker
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 113
|
| unsign
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 114
|
| R. Hammersley
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 115
|
| D. Dobbie
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 116
|
| Doug & Wendy Ellinger
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 117
|
| E.Gorman
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 118
|
| L. Bispo
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 119
|
| N. Allgood
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 120
|
| C. Jarrett
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 121
|
| L. Smith
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 122
|
| L. King
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 123
|
| B. Cummins
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 124
|
| S. Friedrich
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 125
|
| H. Woehlck
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
126
|
| Barbecue Presbyterian Church
|
| Vol #:
|
| 3
|
| |
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
| |
|
|
| C 5
|
| T. Kaeff
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| T. Kaeff
|
| Vol #:
|
| 1
|
| |
|
|
| C 7
|
| C. Yenglin
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
| |
|
|
| LET
4
|
| McNeil Nutritionals LLC
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| 2005N-0036
|
| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
|
| |
|
|
| C
1
|
| West Pharmaceutical Services
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
7
|
| Baxter Healthcare Corp.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
8
Attachment
|
| American Psychological Association
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
9
|
| American Society of Anesthesiologists
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
10
|
| Apotex Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
11
|
| Colorcon
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
12
|
| American Regent Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
13
|
| Clark Container
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| EMC
4
|
| South Georgia Medical Cente
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
5
Page
2
|
| Scripps Cancer Center Institute
|
| Vol #:
|
| 3
|
|
| |
|
| 2005P-0008
|
| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
|
| |
|
|
| EMC
1
|
| Federal Trade Commission
|
| Vol #:
|
| 1
|
| |
|
|
| RC
1
|
| IVAX Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0144
|
| ANDA Suitability for Oxycodone Hydrochloride 20 mg/mL Oral Solution
|
| |
|
|
| ACK
1
|
| HFA-305 to The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0146
|
| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
|
|
|
|
|
|
|
|
|
| ACK
1
|
| HFA-305 to Salix Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Salix Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005V-0145
|
| Laser Light Show
|
| |
|
|
| ACK
1
|
| HFA-305 to Disneyland Resort
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Disneyland Resort
|
| Vol #:
|
| 1
|
|
|
