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| Dockets Entered
On August 29, 2005
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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| |
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| 1999V-0294
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| Laser Light Show
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| |
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2004D-0438
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| Guidance for Industry: Use of Material from BSE-Positive Cattle in Animal Feed
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| |
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| |
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0322
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| Immediately deny approval of the NDA for INCRELEX
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| 2005P-0351
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| Losartan Potassium Oal Solution make a determination that it may be submitted for ANDA
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| 2005V-0309
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16551
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16552
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16553
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16554
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16555
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| NBTY Inc.
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| Vol #:
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| 148
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| LET
16556
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| Somalabs, Inc.
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| Vol #:
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| 148
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| LET
16557
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| Somalabs, Inc.
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| Vol #:
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| 148
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| LET
16558
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| Somalabs, Inc.
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| Vol #:
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| 148
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| LET
16559
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| Somalabs, Inc.
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| Vol #:
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| 148
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| LET
16560
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| Somalabs, Inc.
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| Vol #:
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| 148
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| LET
16561
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| Leiner Health Products
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| Vol #:
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| 148
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| LET
16562
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| Leiner Health Products
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| Vol #:
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| 148
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| LET
16563
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| Leiner Health Products
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| Vol #:
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| 148
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| LET
16564
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| L:einer Health Products
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| Vol #:
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| 148
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| LET
16565
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| Perrigo Company of South Carolina
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| Vol #:
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| 148
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| LET
16566
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| DSM Nutritional Products, Inc.
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| Vol #:
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| 148
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| LET
16567
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| Earthrise Nutritionals, LLC
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| Vol #:
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| 148
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| LET
16568
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| Source naturals
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| Vol #:
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| 148
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| LET
16569
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| The Daily Wellness Company
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| Vol #:
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| 148
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| LET
16570
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| Endomatrix Inc.
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| Vol #:
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| 148
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| LET
16571
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| Hillestad Pharmaceuticals
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| Vol #:
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| 148
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| LET
16572
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| Hillestad Pharmaceuticals
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| Vol #:
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| 148
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| LET
16573
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| Perrigo Company of South Carolina
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| Vol #:
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| 148
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| LET
16574
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| Suarez Corporation Industries
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| Vol #:
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| 148
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| LET
16575
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| Eu Yan Sang(Hong Kong) Limited
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| Vol #:
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| 148
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| LET
16576
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| Solstice Medicine Company
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| Vol #:
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| 148
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| 1999V-0294
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| Laser Light Show
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| VRA
3
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| HFZ-200 to Lost Tribe
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| Vol #:
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| 1
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C
74
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| Daisy Brand
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| Vol #:
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| 2
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| 2004D-0438
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| Guidance for Industry: Use of Material from BSE-Positive Cattle in Animal Feed
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| EC 5
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| Mr. Tad Shelby
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 13
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| HFA-305
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| Vol #:
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| 2
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| OR 12
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| HF-3 to Ecumed Health Group, Amador Reyes, Juan C. Carrai, Richard W. Stone, & Erlinda E. Enr
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| Vol #:
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| 2
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| EC 43
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| Ms. Sandra Davidson
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| EMC
317
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| Juice Products Association
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| Vol #:
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| 3
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| LET
9
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| Solae LLC
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| Vol #:
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| 9
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| EC 2
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| Miss. Patricia Neal
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| C 245
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| L. Trenkamp
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| Vol #:
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| 10
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| C 246
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| P. Olson
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| Vol #:
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| 10
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| C 247
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| L. and W. Bohlinger
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| Vol #:
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| 10
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| C 248
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| C. Colarossi
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| Vol #:
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| 10
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| C 249
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| D. Weissler
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| Vol #:
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| 10
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| C 250
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| D. Hellyer
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| Vol #:
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| 10
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| C 251
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| B. King
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| Vol #:
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| 10
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| C 252
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| T. Allen
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| Vol #:
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| 10
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| C 253
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| B. Hatfield
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| Vol #:
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| 10
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| C 254
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| G. Malon
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| Vol #:
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| 10
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| C 255
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| D. Estes
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| Vol #:
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| 10
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| C 256
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| no signature
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| Vol #:
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| 10
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| C 257
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| L. Raffaelli
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| Vol #:
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| 10
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| C 258
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| no signature
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| Vol #:
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| 10
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| EC
202
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| Mrs. Shannie Smith
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| Vol #:
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| 4
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| EC
203
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| Mr. PAUL LIAZHS
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| Vol #:
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| 4
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| EC
204
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| Mrs. Cheryl Phillips
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| Vol #:
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| 4
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| EC
205
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| Mrs. Leslie Kidder
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| Vol #:
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| 4
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| EC
206
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| Mrs. Mary Thomas
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| Vol #:
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| 4
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| EC
207
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| Mrs. Alicyn Viviano
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| Vol #:
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| 4
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| EC
208
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| Mrs. Suzanne Ludlam
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| Vol #:
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| 4
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| EC
209
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| Ms. Debbie Klein
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| Vol #:
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| 4
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| EC
210
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| Mrs. Jennifer Spencer
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| Vol #:
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| 4
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| EC
211
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| Mr. Donald Mewhort
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| Vol #:
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| 4
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| EC
212
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| Mrs. Marie Hasse
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| Vol #:
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| 4
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| EC
213
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| Mrs. Debra Kovacs
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| Vol #:
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| 4
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| EC
214
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| Mrs. Deanna Nied
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| Vol #:
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| 4
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| EC
215
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| Mrs. M. Madeline Prokop
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| Vol #:
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| 4
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| EC
216
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| Mr. jeff faul
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| Vol #:
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| 4
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| |
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| EC
217
|
| Gastorintestinal Health Associates
|
| Vol #:
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| 4
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| |
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| EC
218
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| Ms. CHERIE JOHNSON
|
| Vol #:
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| 4
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| EC
219
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| Ms. Connie Bernard
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| Vol #:
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| 4
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| |
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| EC
220
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| Miss. Anita Baranowski
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| Vol #:
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| 4
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| |
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| EC
221
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| Mrs. Kim Becker
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| Vol #:
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| 4
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| |
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| EC
222
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| Mrs. Diane Cocherell
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| Vol #:
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| 4
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| |
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| EC
223
|
| Ms. Julieanne Hensley
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| Vol #:
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| 4
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| |
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| EC
224
|
| Mrs. Joyce Lansdon
|
| Vol #:
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| 4
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| |
|
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| EC
225
|
| CSAUSA
|
| Vol #:
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| 4
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| |
|
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| EC
226
|
| Ms. Lori Hamburg
|
| Vol #:
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| 4
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| |
|
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| EC
227
|
| Ms. Catherine P. Lund
|
| Vol #:
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| 4
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| |
|
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| EC
228
|
| Mrs. Jaunny Luta
|
| Vol #:
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| 4
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| |
|
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| EC
229
|
| Ms. Cathy Enright
|
| Vol #:
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| 4
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|
| | | | | | | |
| |
|
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| EC
230
|
| Dr. Richard Roach
|
| Vol #:
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| 4
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| |
|
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| EC
231
|
| Mrs. Lynn Roach
|
| Vol #:
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| 4
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| |
|
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| EC
232
|
| Mrs. Linda Neal
|
| Vol #:
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| 4
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| |
|
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| EC
233
|
| Mrs. Sandra Mitchell
|
| Vol #:
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| 4
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| |
|
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| EC
234
|
| Mr. Matthew Brott
|
| Vol #:
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| 4
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| |
|
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| EC
235
|
| Mr. david hiscock
|
| Vol #:
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| 4
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| |
|
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| EC
236
|
| Mrs. Sarah Bradshaw
|
| Vol #:
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| 4
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| |
|
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| EC
237
|
| Mr. Marc LeBeau
|
| Vol #:
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| 4
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| |
|
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| EC
238
|
| Celiac Disease On-Line Support Group
|
| Vol #:
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| 4
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| |
|
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| EC
239
|
| Mrs. Julie Brueck
|
| Vol #:
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| 4
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| |
|
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| EC
240
|
| Mrs. Claire Fisher
|
| Vol #:
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| 4
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| |
|
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| EC
241
|
| Ms. Virginia Menz
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| Vol #:
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| 4
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| |
|
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| EC
242
|
| Ms. Karen Oland
|
| Vol #:
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| 4
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| |
|
|
| EC
243
|
| Mrs. Gloria Mills
|
| Vol #:
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| 4
|
| |
|
|
| EC
244
|
| Contemporary Healthcare, P. C.
|
| Vol #:
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| 4
|
| |
|
|
| EC
245
Attachment
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| Miss. Armen Czepyha
|
| Vol #:
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| 4
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| |
|
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| EC
246
|
| Mr. William Lynn
|
| Vol #:
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| 4
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| |
|
|
| EC
247
|
| Mr. Mark Snowden
|
| Vol #:
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| 4
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| |
|
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| EC
248
|
| Mrs. terri audrain
|
| Vol #:
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| 4
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| |
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| EC
249
|
| Mrs. Karen Kushnir
|
| Vol #:
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| 4
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| |
|
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| EC
250
|
| Mr. Ronald Burns
|
| Vol #:
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| 4
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| |
|
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| EC
251
|
| Mrs. Brenda Crawford
|
| Vol #:
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| 4
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| |
|
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| EC
252
|
| Mister Marty's Gluten Free Foods
|
| Vol #:
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| 4
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| |
|
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| EC
253
|
| Ms. elizabeth woodcock
|
| Vol #:
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| 4
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| |
|
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| EC
254
|
| Mr. Timothy Gehring
|
| Vol #:
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| 4
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| |
|
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| EC
255
|
| Ms. Rose Wilson Parvaz
|
| Vol #:
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| 4
|
| |
|
|
| EC
256
|
| Miss. Alexandra Parvaz
|
| Vol #:
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| 4
|
| |
|
|
| EC
257
|
| Ms. patricia forbes
|
| Vol #:
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| 4
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| |
|
|
| EC
258
|
| Mr. Robert Shedd
|
| Vol #:
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| 4
|
| |
|
|
| EC
259
|
| Mr. Mark Schonebaum
|
| Vol #:
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| 4
|
| |
|
|
| EC
260
|
| Miss. Whitney Dorer
|
| Vol #:
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| 4
|
| |
|
|
| EC
261
|
| Mrs. rose appel
|
| Vol #:
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| 4
|
| |
|
|
| EC
262
|
| Mrs. Sharon Findley
|
| Vol #:
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| 4
|
| |
|
|
| EC
263
|
| Dr. Seymour Sohmer
|
| Vol #:
|
| 4
|
| |
|
|
| EC
264
|
| Mrs. Linda Ortman
|
| Vol #:
|
| 4
|
| |
|
|
| EC
265
|
| Mrs. Linda Ortman
|
| Vol #:
|
| 4
|
| |
|
|
| EC
266
|
| Mrs. barbara Donahue
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
| |
|
|
| EC
267
|
| Mrs. barbara Donahue
|
| Vol #:
|
| 4
|
| |
|
|
| EC
268
|
| Mr. Allan Mac Intrye
|
| Vol #:
|
| 4
|
| |
|
|
| EC
269
|
| Mrs. Robin Leary
|
| Vol #:
|
| 4
|
| |
|
|
| EC
270
|
| Miss. Patricia Nfeal
|
| Vol #:
|
| 4
|
| |
|
|
| EC
271
|
| Mr. marvin clegg
|
| Vol #:
|
| 4
|
| |
|
|
| EC
272
|
| Miss. Shannon Sciascia
|
| Vol #:
|
| 4
|
| |
|
|
| EC
273
|
| Mr. Chris Ochman
|
| Vol #:
|
| 4
|
| |
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
| |
|
|
| EC 4
|
| Mr. Michael Bilz
|
| Vol #:
|
| 2
|
| |
|
|
| EC 5
|
| Miss. LAURA CUNNINGHAM
|
| Vol #:
|
| 2
|
| |
|
|
| EC 6
|
| Mr. Evan Goodman
|
| Vol #:
|
| 2
|
| |
|
|
| EC 7
|
| Ms. Jennifer Dawson
|
| Vol #:
|
| 2
|
| |
|
|
| EC 8
|
| Ms. Megan MacBride
|
| Vol #:
|
| 2
|
| |
|
|
| EC 9
|
| Dr. TRACI CORDER
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
| |
|
|
| C 1
|
| B. Kataria, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 2
|
| B. Broad, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 3
|
| D. Ostrander, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 4
|
| M. Shatz, MD
|
| Vol #:
|
| 2
|
| |
|
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| C 5
|
| J. Keaidin
|
| Vol #:
|
| 2
|
| |
|
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| C 6
|
| A. Herlich,DMD,MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 7
|
| R. Ananda, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 8
|
| M. Wolf, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 9
|
| J. Ramos, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 10
|
| R. Achecar, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 11
|
| S. Bhaskara, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 12
|
| S. Cifor, D.O.
|
| Vol #:
|
| 2
|
| |
|
|
| C 13
|
| D. Atkinson, MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 14
|
| Form Letters
|
| Vol #:
|
| 3
|
| |
|
|
| EC 31
|
| Panhandle Anesthesiology Assoc. PA
|
| Vol #:
|
| 2
|
| |
|
|
| EC 32
|
| Dr. Jennifer Dagen
|
| Vol #:
|
| 2
|
| |
|
|
| EC
33
|
| Old Pueblo Anesthesia, PC
|
| Vol #:
|
| 2
|
| |
|
|
| EC 34
|
| Dr. David Susman
|
| Vol #:
|
| 2
|
| |
|
|
| EC
35
|
| Magnolia Anesthesia, LLP
|
| Vol #:
|
| 2
|
| |
|
|
| EC 36
|
| Dr. Janet Siler
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
| |
|
|
| EC 37
|
| Dr. Glenn Dragon
|
| Vol #:
|
| 2
|
| |
|
|
| EC 38
|
| Dr. Jeffrey Weinstein
|
| Vol #:
|
| 2
|
| |
|
|
| EC 39
|
| Dr. William Goldstein
|
| Vol #:
|
| 2
|
| |
|
|
| EC 40
|
| Dr. zvi Herschman
|
| Vol #:
|
| 2
|
| |
|
|
| EC 41
|
| Dr. David Simons
|
| Vol #:
|
| 3
|
| |
|
|
| EC 42
|
| Dr. NIlesh Patel
|
| Vol #:
|
| 2
|
| |
|
|
| EC
43
|
| North Florida Anesthesia Consultants
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0322
|
| Immediately deny approval of the NDA for INCRELEX
|
| |
|
|
| RC
1
Attachment
|
| Insmed Incorporated
|
| Vol #:
|
| 3
|
| |
|
|
| 2005P-0323
|
| Immediately remove Adderall and Adderall XR from the market for safety reasons
|
| |
|
|
| EC 1
|
| Ms. Sara Graham
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0351
|
| Losartan Potassium Oal Solution make a determination that it may be submitted for ANDA
|
| |
|
|
| CP
1
|
| Morton Grove Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2005V-0309
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-200 to Topeka Fun Inc, /DBA Lollipops Gentlemens Club
|
| Vol #:
|
| 1
|
|
|
