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| Dockets Entered
On November 5, 2004
Table of Contents
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| Docket #
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| Title
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| 2004P-0488
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| Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
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| 2004P-0489
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| ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 681
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| Bayer Corporation
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| Vol #:
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| 461
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| SUP
1
Presentation
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| Columbia University
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| Vol #:
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| 1
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| SUP
2
Presentation
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| University of Tennessee Medical Center
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| Vol #:
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| 1
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| SUP
3
Presentation
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| Xceleron Ltd
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| Vol #:
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| 1
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| SUP
4
Presentation
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| Xceleron Ltd
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| Vol #:
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| 1
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| SUP
5
Presentation
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| University of Tennessee Medical Center
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| Vol #:
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| 1
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| SUP
6
Presentation
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| Society of Nuclear Medicine
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| Vol #:
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| 1
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| SUP
7
Presentation
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| Cincinnati Children's Hospital
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| Vol #:
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| 1
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| SUP
8
Presentation
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| Univerisyt of Tennessee Graduate School of Medicine RDRC
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| Vol #:
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| 1
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| SUP
9
Presentation
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| Emory University School of Medicine
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| Vol #:
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| 1
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| SUP
10
Presentation
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| Cincinnati Children's Hospital
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| Vol #:
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| 1
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| SUP
11
Presentation 1, 2
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| Washington University School of Medicine
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| Vol #:
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| 1
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| 2004P-0091
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| To premarket approval (PMA) for the gastric electrical stimulation ( GES), level III device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis
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| PDN
1
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| HFZ-1 to Gastroparcsis & Dysmotilities Assn.
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| Vol #:
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| 1
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| C
5
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| AstraZeneca Pharmaceuticals LP
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| Vol #:
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| 1
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| 2004P-0488
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| Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
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| ACK
1
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| HFA-305 to GlaxoSmithKline
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| Vol #:
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| 1
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| CP
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2004P-0489
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| ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection
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| ACK
1
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| HFA-305 to Bioniche Animal Health USA, Inc.
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| Vol #:
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| 1
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| C 1
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| Number not used
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| Vol #:
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| 1
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| CP
1
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| Bioniche Animal Health USA, Inc.
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| Vol #:
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| 1
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