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| Dockets Entered
On April 15, 2004
Table of Contents
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| Docket #
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| Title
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| 1986V-0327
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| LASER-GRAPH SERIES I, SERIES II
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| 1988P-0072
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| NIFEDIPINE HARD GELATIN CAPSULES 20MG ANDA SUITABILITY
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| 1995P-0326
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| ANDA for Nifedipine Extended-release Capsules
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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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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0145
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| Change the classification of colonic irrigation systems
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002P-0377
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| Petition Requesting Stay of Approval of Mifeprex
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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-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| 2003D-0558
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| Guidance Levels for Radionuclides in Domestic and Imported Foods
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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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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0035
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| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 1986V-0327
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| LASER-GRAPH SERIES I, SERIES II
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| VRA
8
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| HFZ-300 to Rarefied Media Productions
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| Vol #:
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| 1
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| 1988P-0072
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| NIFEDIPINE HARD GELATIN CAPSULES 20MG ANDA SUITABILITY
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| ACK
1
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| HFA-305 to Marteo Pharmaceutical, Inc.
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| Vol #:
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| 1
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| 1995P-0326
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| ANDA for Nifedipine Extended-release Capsules
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| ACK 1
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| HFA-305 to KV Pharmaceutical Co.
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| Vol #:
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| 1
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| ACK 2
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| HFA-305 to Bayer Corporation
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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
13599
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| Perrigo Company of South Carolina
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| Vol #:
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| 113
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| LET
13600
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| Perrigo Company of South Carolina
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| Vol #:
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| 113
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| LET
13601
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| Dynamic Nutrional Products
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| Vol #:
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| 113
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| LET
13602
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| Twin Laboratories
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| Vol #:
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| 113
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| LET
13603
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| Amrita Veda
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| Vol #:
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| 113
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| LET
13604
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| Herb Pharm
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| Vol #:
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| 113
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| LET
13605
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| Herb Pharm
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| Vol #:
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| 113
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| LET
13606
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| Awareness Corporation
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| Vol #:
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| 114
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| LET
13607
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| Awareness Corporation
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| Vol #:
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| 114
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| LET
13608
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| AdvoCare International, L.P.
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| Vol #:
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| 114
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| LET
13609
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13610
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| InteMedica, LLC
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| Vol #:
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| 114
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| LET
13611
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| Metagenics, Inc.
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| Vol #:
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| 114
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| LET
13612
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| Gaia Herbs
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| Vol #:
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| 114
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| LET
13613
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| Herb Pharm
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| Vol #:
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| 114
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| LET
13614
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| Herb Pharm
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| Vol #:
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| 114
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| LET
13615
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| Herb Pharm
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| Vol #:
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| 114
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| LET
13616
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| Herb Pharm
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| Vol #:
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| 114
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| LET
13617
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| Herb Pharm
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| Vol #:
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| 114
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| LET
13618
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13619
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13620
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13621
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13622
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13623
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13624
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| Perrigo Company of South Carolina
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| Vol #:
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| 114
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| LET
13625
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| Vitacorp International, Inc.
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| Vol #:
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| 114
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| LET
13626
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| Shaklee's Corporation
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| Vol #:
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| 114
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| LET
13627
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| LET
13628
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| Wise Women Herbals
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| Vol #:
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| 114
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| LET
13629
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13630
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13631
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13632
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13633
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| LET
13634
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| LET
13635
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4195
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| G. Ocepeck
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| Vol #:
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| 515
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 531
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| A. Adams
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| Vol #:
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| 24
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 779
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| J. Cecil
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| Vol #:
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| 33
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EMC 557
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| Form Letter Count 2026
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| Vol #:
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| 399
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C
1340
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| Legal Center for Defense of Life, Inc.
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| Vol #:
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| 209
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| 2001P-0145
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| Change the classification of colonic irrigation systems
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| LET
1
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| HFZ-400 to Mr. A.R. Hoenninger
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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 328
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| Dr. B. Martini
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| Vol #:
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| 6
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| 2002P-0377
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| Petition Requesting Stay of Approval of Mifeprex
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| EMC
1
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| American Assn of Pro-Life Obstetricians & Gynecologists
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| Vol #:
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| 2
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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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| C
12
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| International Assn for Pharmaceutical Science and Technology (PDA)
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| Vol #:
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| 2
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| C
14
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| Laboratory Corporation of America (LabCorp)
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| Vol #:
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| 1
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| 2003D-0558
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| Guidance Levels for Radionuclides in Domestic and Imported Foods
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| EMC
1
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| Chinese Government
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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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| C
18
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| American Palm Oil Council (APOC)
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| Vol #:
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| 3
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| EMC 159
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| T. Slocombe
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| Vol #:
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| 3
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| EMC 160
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| D. Young
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| Vol #:
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| 3
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| EMC 161
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| K. Simpson
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| Vol #:
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| 3
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| EMC 162
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| H. Walsh
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| Vol #:
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| 3
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 68
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| R. Berman
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| Vol #:
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| 6
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 56
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| N. Norman
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| Vol #:
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| 2
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| EMC 57
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| F. Nemkov
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| Vol #:
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| 2
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| EMC 25
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| F. Nemkov
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| Vol #:
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| 1
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| C 2
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| E. Abraham
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| Vol #:
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| 2
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| C 3
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| W. Deehan
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| Vol #:
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| 2
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| C 4
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| Illegible
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| Vol #:
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| 2
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| C
13
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| Our Bodies Ourselves (OBOS)
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| Vol #:
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| 1
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| C
14
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| National Women's Health Network
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| Vol #:
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| 1
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| 2004D-0035
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| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
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| EMC
1
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| H. Bone, MD
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| Vol #:
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| 1
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| EMC
2
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| EMC
3
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| P&G Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004N-0115
|
| Prescription Drug Importation Study
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| EMC
6
Attachment
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| drugstore.com
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| Vol #:
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| 1
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|
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| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
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| ACK
1
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| HFS-800 to Solae, LLC
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| Vol #:
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| 4
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| LET
1
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| The Solae Company
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| Vol #:
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| 4
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| QHC
1
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| Solae, LLC
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| Vol #:
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| 1
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