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| Dockets Entered
On May 12, 2005
Table of Contents
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| Docket #
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| Title
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| 1992V-0087
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| Laser effects for "Fantasmic" show
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000V-1453
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| Laser Light Show (Golden Dreams Laser Special Effects)
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2002E-0020
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| Patent Term Application for Zometa No. 4,939,130
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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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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| 2004P-0513
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| to amend regulation update "Estrogens Increase The Risk of Enfometrial Cancer prescribing info of all strengths of Premarin tablets
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| 2005D-0101
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| Guidance: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Asociated Delivery System
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0034
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| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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| 2005P-0173
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| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| 1992V-0087
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| Laser effects for "Fantasmic" show
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| EXP 1
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| Disneyland Resort
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7481
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| C. Wondra
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| Vol #:
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| 319
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| 2000V-1453
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| Laser Light Show (Golden Dreams Laser Special Effects)
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| EXP 1
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| Disneyland Resort
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| 1
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| C
10
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| Pear Bureau Northwest (Pea Bureau)
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| Vol #:
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| 1
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| 2002E-0020
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| Patent Term Application for Zometa No. 4,939,130
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| LET
5
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| Novartis
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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 146
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| R. Anderlik
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| Vol #:
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| 9
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| C 147
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| S. Eakins
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| Vol #:
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| 9
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| C 148
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| B. Snelling
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| Vol #:
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| 9
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| C 149
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| J. McMann
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| Vol #:
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| 9
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| C 150
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| Mr and Mrs G. Malandrucco
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| Vol #:
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| 9
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| C 151
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| N. Kramer
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| Vol #:
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| 9
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| C 152
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| R. Grover
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| Vol #:
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| 9
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| C 153
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| J. Tolpin
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| Vol #:
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| 9
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| C 154
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| L. Thew
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| Vol #:
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| 9
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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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| EMC 731
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| L. Norris
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| Vol #:
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| 4
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| EMC 732
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| K. S. Hjelle
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| Vol #:
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| 4
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| EMC 733
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| R. Phillips
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| Vol #:
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| 4
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| EMC 734
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| C. Hoffman
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| Vol #:
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| 4
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| EMC 735
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| unsign
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| Vol #:
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| 4
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| EMC 736
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| unsign
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| Vol #:
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| 4
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| EMC 737
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| K. Janes
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| Vol #:
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| 4
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| 2004P-0513
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| to amend regulation update
"Estrogens Increase The Risk of Endometrial Cancer prescribing
info of all strengths of Premarin tablets
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| LET
1
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| HFD-005 to Beth Rosenshein
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| Vol #:
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| 1
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| 2005D-0101
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| Guidance: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Asociated Delivery System
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| C 2
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| B. Berg
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| C 1
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| J. Hershman, MD
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| Vol #:
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| 1
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| RC
2
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| IVAX Corporation
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| Vol #:
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| 1
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| 2005P-0034
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| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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| C 1
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| P. Udovenko
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| Vol #:
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| 1
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| 2005P-0173
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| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
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| SUP
1
Attachment
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| Buchanan Ingersoll
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| Vol #:
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| 1
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| 2005P-0182
|
| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| CP
1
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| Antibody Systems, Inc.
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| Vol #:
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| 1
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| ACK
1
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| HFA-305 to Antibody Systems, Inc.
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| Vol #:
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| 1
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