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| Dockets Entered
On May 25, 2004
Table of Contents
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| Docket #
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| Title
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2003D-0538
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| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2003P-0576
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| Warning Label for all Food Products Which Contain Gluten
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2004P-0247
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| Escitalopram oxalate my be filed for ANDA capsuel dosage form
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| WDL
1
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| International Formula Council
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| Vol #:
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| 9
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
25
Attachments
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| University of Washington IDE#G980067
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| Vol #:
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| 19
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| SUP
26
Attachment 1, Other
Attachments
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 26
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| NFR
1
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| FDA
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| Vol #:
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| 27
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13959
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| Bios Biochemicals Corp.
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| Vol #:
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| 119
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| LET
13960
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| Now Foods
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| Vol #:
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| 119
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| LET
13961
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| Natural Organics, Inc.
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| Vol #:
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| 119
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| LET
13962
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| Source Naturals
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| Vol #:
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| 119
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| LET
13963
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| Source Naturals
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| Vol #:
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| 119
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| LET
13964
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| Biotech corporation
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| Vol #:
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| 119
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| CR
4
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| Bayer Corporation & Animal Health Institute
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| Vol #:
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| 389
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| SUP
9
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| Bayer Corporation & Animal Health Institute
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| Vol #:
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| 389
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| C
546
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| Stockbridge Family Medicine
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| Vol #:
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| 30
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| MT
1
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| HFS-24 and Stockbridge Family Medicine
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| Vol #:
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| 30
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| NCR
4
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| FDA
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| Vol #:
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| 28
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| 2003D-0538
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| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
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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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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| RMO
2
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| GCF-1
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| Vol #:
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| 2
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0576
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| Warning Label for all Food Products Which Contain Gluten
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| MT
1
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| HFS-24 and Stockbridge Family Medicine
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| Vol #:
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| 1
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| EMC 1
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| Consumer
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| Vol #:
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| 1
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| EMC
3
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| King Pharmaceuticals, Inc
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| Vol #:
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| 2
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| SUP
2
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| Mutual Pharmaceutical Co., Inc
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| Vol #:
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| 2
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| 2004P-0247
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| Escitalopram oxalate my be filed for ANDA capsuel dosage form
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| ACK
1
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| Alphapharm Pty Ltd of Glebe
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| Vol #:
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| 1
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| CP
1
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| Alphapharm Pty Ltd of Glebe
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| Vol #:
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| 1
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| SUP
1
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| Marine Bio USA Inc
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| Vol #:
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| 6
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