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| Dockets Entered
On March 10, 2004
Table of Contents
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| Docket #
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| Title
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| 1996N-0277
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| Eligibility Criteria for Considering Additional Condition
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| 1996P-0276
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| Reclassify Arrhythmia Detector and Alarm
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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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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| 2000P-0685
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| Revise of Yogurt Standards
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0137
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| Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0561
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| Orthopedic Devices; Effective Date of the Proposed Requirement for Premarket Approval of the Hip Joint Metal/Polymer or Ceramic/Polymer Semi-constrained Resurfacing Cemented Prosthesis
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2003Q-0559
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| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004M-0116
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| P030006 - Prolieve Thermodilatation System
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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-0123
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| Glimepiride Tablets, 3mg and 6mg for an Abbreviated new drug application ( ANDA )
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| EMC 1267
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| No signatue
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| Vol #:
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| 378
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| EMC 1268
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| A. Hogan
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| Vol #:
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| 378
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| EMC 1269
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| V. Courtney
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| Vol #:
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| 378
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| EMC 1270
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| J. Stotts
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| Vol #:
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| 378
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| EMC 1271
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| G. Haring
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| Vol #:
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| 378
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| RPT
91
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| List as of March 9, 2004
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| Vol #:
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| 7
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| 1996N-0277
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| Eligibility Criteria for Considering Additional Condition
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| LET
15
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| HFD-560 to Pharm1 Medicine Technology Inc
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| Vol #:
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| 5
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| 1996P-0276
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| Reclassify Arrhythmia Detector and Alarm
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13127
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13128
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13129
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13130
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13131
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13132
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13133
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13134
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13135
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13136
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13137
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13138
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13139
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13140
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 107
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| LET
13141
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13142
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13143
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13144
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13145
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13146
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13147
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13148
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13149
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13150
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13151
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| Lidtke Technologies Corp.
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| Vol #:
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| 107
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| LET
13152
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| Lidtke Technologies,Corp.
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| Vol #:
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| 107
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| LET
13153
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| Lidtke Technologies, Corp.
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| Vol #:
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| 107
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| LET
13154
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| NBTY Inc.
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| Vol #:
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| 107
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| LET
13155
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| NBTY Inc.
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| Vol #:
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| 107
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| | | | | | | | |
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 153
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| No signature
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| Vol #:
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| 3
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 316
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| Dr. B. Martini
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| Vol #:
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| 6
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| EMC 317
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| Dr. B. Martini
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| Vol #:
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| 6
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| EMC 318
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| Dr. B. Martini
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| Vol #:
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| 6
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| 2003D-0137
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| Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability
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| GDL
2
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| EMC
3
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| Amgen
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| Vol #:
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| 1
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| EMC
4
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| Pfizer, Inc.
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| Vol #:
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| 1
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| EMC
5
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EMC
6
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| Product Quality Research Institute (PQRI)
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| Vol #:
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| 1
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| EMC
7
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| KV Pharmaceutical Company
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| Vol #:
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| 1
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| EMC
11
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| Iconix Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| STP
1
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| HFZ-215 and Korancy Radiology Associates, P.A.
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 142
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| Milly
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| Vol #:
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| 3
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| EMC 143
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| Milly
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| Vol #:
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| 3
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| 2003N-0561
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| Orthopedic Devices; Effective Date of the Proposed Requirement for Premarket Approval of the Hip Joint Metal/Polymer or Ceramic/Polymer Semi-constrained Resurfacing Cemented Prosthesis
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| BKG 1
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| BACKGROUND
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| Vol #:
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| 1
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
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| C 6
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| Sr C Rea
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| Vol #:
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| 1
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| 2003Q-0559
|
| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
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| C
6
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| Borges USA
|
| Vol #:
|
| 5
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