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Dockets
Entered On June 26, 2003
TABLE OF
CONTENTS (Linked) |
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Docket #
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Title
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2002D-0526
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Guidance for drug Chemistry,
Manufacturing, Control Info. |
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2002N-0204
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Bar Code Label Requirements
for human drug products |
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2002P-0450
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Withhold Approval of ANDA for
Amino Acid Solution Drug Prod. |
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2003D-0061
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Comparability Protocols Chemistry
Manufacturing and controls |
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2003D-0118
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Decorative Contact Lens (Import
alert #86-10) |
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2003P-0160
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FDA to send letter ruling refusing
to approve loratadine tab |
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| CONTENTS |
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1991N-0245 |
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Cosmetic Products Containing
Certain Hormone Ingredients |
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C 4 |
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Audria Fowler |
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Vol #: |
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2 |
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1998P-0151 |
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Introduction Of Downed Cattle
Into The Food Supply |
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C 6600 |
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Ms. Julie A. Beckham
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Vol #: |
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282 |
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C 6601 |
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Morgan Connery |
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Vol #: |
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282 |
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C 6602 |
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Allen Wierman |
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Vol #: |
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282 |
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C 6603 |
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Dealy-Doe-Eyes Maddux
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Vol #: |
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282 |
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C 6604 |
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Mrs. Sherrill F. Wood
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Vol #: |
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282 |
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C 6605 |
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Teresa Borden |
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Vol #: |
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282 |
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C 6606 |
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Gypsy Bradley |
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Vol #: |
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282 |
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C 6607 |
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Marquerito Velasguez
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Vol #: |
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282 |
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C 6608 |
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Peter Nolan |
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Vol #: |
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282 |
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C 6609 |
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Marian F. McAleenan
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Vol #: |
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282 |
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C 6610 |
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Debra G. Erickson |
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Vol #: |
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282 |
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C 6611 |
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Carol Elmore |
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Vol #: |
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282 |
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C 6612 |
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Caryn Cook |
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Vol #: |
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282 |
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C 6613 |
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Ludmilla Martens |
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Vol #: |
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282 |
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C 6614 |
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Mary Jo Luu |
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Vol #: |
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282 |
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C 6615 |
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Dot Pixley |
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Vol #: |
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282 |
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C 6616 |
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Irene L. Ray |
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Vol #: |
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282 |
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C 6617 |
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Lynn |
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Vol #: |
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282 |
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C 6618 |
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S. Matthews |
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Vol #: |
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282 |
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2002D-0385 |
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Approval of Labeling for Foods
Treated by Irradiation |
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C 15 |
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Jeanne Pendergast |
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Vol #: |
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1 |
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2002D-0526 |
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Guidance
for drug Chemistry, Manufacturing, Control Info. |
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C 4 |
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Jerussi Consulting, Inc.
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Vol #: |
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1 |
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C 5 |
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Aventis Pharmaceuticals, Inc.
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Vol #: |
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1 |
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C 6 |
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P&G Pharmaceuticals, Inc.
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Vol #: |
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1 |
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C 7 |
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Bristol-Myers Squibb
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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 12 |
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HFA-305 |
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Vol #: |
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1 |
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CS 13 |
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HFA-305 |
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Vol #: |
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1 |
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MO 10 |
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GCF-1 (General Counsel)
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Vol #: |
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2 |
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OR 10 |
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HF-3 |
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Vol #: |
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1 |
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OR 11 |
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HF-3 |
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Vol #: |
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1 |
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2002N-0204 |
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Bar
Code Label Requirements for human drug products |
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C 116 |
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New Hersey Hospital Assn
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Vol #: |
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15 |
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2002N-0277 |
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Bioterrorism; Establishment
& Maintenance of Records |
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C 32 |
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Distribution & LTL Carriers
Assn |
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Vol #: |
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8 |
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2002N-0434 |
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Withdrawel of Certain Proposed
rules & other propose action |
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C 1 |
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Peggy Marko-Sprague
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Vol #: |
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1 |
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C 2 |
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Form Letters |
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Vol #: |
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2 |
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C 3 |
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Audria Fowler |
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Vol #: |
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1 |
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2002P-0450 |
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Withhold
Approval of ANDA for Amino Acid Solution Drug Prod. |
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PDN 1 |
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HFD_1 to B. Braun Medical Inc.
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Vol #: |
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1 |
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2003D-0061 |
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Comparability
Protocols Chemistry Manufacturing and controls |
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C 4 |
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Centocor |
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Vol #: |
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1 |
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C 5 |
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Aventis Pharmaceuticals, Inc.
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Vol #: |
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1 |
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C 6
Attachment 1
Attachment 2 |
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International Assn for Pharceutical
Science and Technology (PDA) |
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Vol #: |
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1 |
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C 7 |
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Baxter Healthcare Corporation
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Vol #: |
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1 |
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C 8
Attachment 1 |
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Novartis Pharmaceuticals, Corporation
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Vol #: |
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1 |
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2003D-0118 |
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Decorative
Contact Lens (Import alert #86-10) |
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C 24 |
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W. Edward Culbertson, O.D.
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Vol #: |
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1 |
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C 25 |
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Optometry Assn of Louisiana
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Vol #: |
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1 |
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C 26 |
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Adam P. Parker O.D.
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Vol #: |
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1 |
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C 27 |
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Cheryl T. Bloom, O.D.
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Vol #: |
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1 |
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C 28 |
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Mid-Valley Eye Centers
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Vol #: |
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1 |
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C 29 |
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Frederick Bergman, O.D.
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Vol #: |
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1 |
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C 30 |
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Dr. Laurel Beth Gropper
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Vol #: |
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1 |
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2003D-0231 |
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Draft Guidance for Industry
on Providing Regulatory Submissions in Electronic Format -- Postmarketing
Periodic Adverse Drug Experience Reports; Availability |
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GDL 1
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GUIDANCE |
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Vol #: |
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1 |
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NAD 1
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FDA |
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Vol #: |
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1 |
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2003N-0169 |
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Dental Amalgam; Request for
Information |
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C 9 |
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Honorable Dan Burton
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Vol #: |
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4 |
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2003P-0160 |
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FDA
to send letter ruling refusing to approve loratadine tab |
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C 4 |
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Wyeth |
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Vol #: |
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1 |
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2003P-0270 |
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Prohibit False and Misleading
Labeling |
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C 1 |
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Sarah Mugford |
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Vol #: |
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1 |
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C 2 |
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Claudia Wondra |
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Vol #: |
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1 |
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C 3 |
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Susan Prolman, Esq.
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Vol #: |
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1 |
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C 4 |
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Jerry Simonelli (attorney At
Law) |
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Vol #: |
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1 |
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C 5 |
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Holly Wertheimer |
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Vol #: |
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1 |
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C 6 |
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Scantek, Inc. |
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Vol #: |
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1 |
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C 7 |
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Form Letters |
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Vol #: |
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2 |
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C 8 |
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Form Letters |
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Vol #: |
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3 |
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C 9 |
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Form Letters |
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Vol #: |
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4 |
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2003V-0080 |
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Laser Light Show |
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VRA 1 |
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HFZ-300 to Sierra Flo Co.,
LLC |
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Vol #: |
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1 |
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2003V-0230 |
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Laser Light Show |
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VRA 1 |
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HFZ-300 to River Palm Resort
Casino |
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Vol #: |
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1 |
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