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| Dockets Entered
On December 10, 2003
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1980A-0209
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| Legal Name for Ice Cream Products
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| 1981P-0306
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| RECLASS PETITION 513(F) PROPHYLACTIC W/ SPERMICIDAL LUBRI
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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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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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0546
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| ANDA for Covera-HS
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols - Protein Drug Products and Biologic Products - Chemistry, Manufacturing, and Controls Information
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003N-0338
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| Obesity
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0422
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| Annual Stakeholder Meeting on the Implementation of MDUFMA Provisions
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| 2003N-0456
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| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
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| 2003N-0470
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| Preparation for ICH meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003: Public Meeting
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0278
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| Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing od drugs
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| 2003P-0280
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| Determine that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices
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| 2003P-0398
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| (ANDA) for Oral Capsule Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital 50 mmg/ Cafferine 40mg/ Acetaminophen 325mg
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| 2003P-0469
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| ANADA Suitability for Ivermectin Hard-Chew Anthelmintic for (non-food) Horses
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| 2003P-0523
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| ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses
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| 2003P-0530
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| Silicone Gel-filled Breast Implants
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| 2003P-0552
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| ANADA for a generic new animal drug caroprofen
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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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| 2003Q-0547
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| Health Claim Notification: Whole Grains and Coronary Heart Disease
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| 1978N-0036L
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| OTC Laxative
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| ACK
29
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| HFA-305 to CIBA Consumer Pharmaceuticals
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| Vol #:
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| 69
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| 1980A-0209
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| Legal Name for Ice Cream Products
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| ACK
1
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| HFA-305 to Flavor & Extract Manufacturers
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| Vol #:
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| 1
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| LET
16
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| Bureau of Food
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| Vol #:
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| 1
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| SUP
2
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| National Food Inccredient Co
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| Vol #:
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| 1
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| 1981P-0306
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| RECLASS PETITION 513(F) PROPHYLACTIC W/ SPERMICIDAL LUBRI
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| ACK
1
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| HFA-305 to Schmid Products Co.
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| Vol #:
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| 1
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| ACK 2
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| Hamel, Park, McCabe & Saunders
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| Vol #:
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| 1
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| LST 88
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| List as of December 3, 2003
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| Vol #:
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| 7
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11889
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11890
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11891
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11892
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11893
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| Cognis Corporation
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| Vol #:
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| 93
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| LET
11894
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| Food Science of Vermont
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| Vol #:
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| 93
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| LET
11895
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| Food Science of Vermont
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| Vol #:
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| 93
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| LET
11896
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| Food Science of Vermont
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| Vol #:
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| 93
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| LET
11897
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11898
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| LET
11899
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| LET
11900
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| LET
11901
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| Patent Health, LLC
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| Vol #:
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| 94
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| LET
11902
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| Marco Polo Technologies,Inc
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| Vol #:
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| 94
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| LET
11903
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| Solstice Medicine Company
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| Vol #:
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| 94
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| LET
11904
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| Solstice Medicine Company
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| Vol #:
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| 94
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| LET
11905
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| Integrative Therapeutics Inc.
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| Vol #:
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| 94
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| LET
11906
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 94
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| LET
11907
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| Intetrative Therapeutics Inc.
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| Vol #:
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| 94
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| LET
11908
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| Reliance Vitamin Company, Inc.
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| Vol #:
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| 94
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| LET
11909
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| Nature's Way Products, Inc.
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| Vol #:
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| 94
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| LET
11910
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| Synergy Worldwide
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| Vol #:
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| 94
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| LET
11911
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| Botanical Solutions, Inc.
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| Vol #:
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| 94
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| LET
11912
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| Perrigo Company of South Carolina
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| Vol #:
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| 94
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| LET
11913
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| MACA US Sales
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| Vol #:
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| 94
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| LET
11914
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| Perrigo Company of South Carolina
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| Vol #:
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| 94
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| LET
11915
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| Perrigo Company of South Carolina
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| Vol #:
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| 94
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| LET
11916
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| Gaia Herbs
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| Vol #:
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| 94
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7305
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| Doris Belanger
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| Vol #:
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| 305
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| C 7306
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| Barbara Kwasnik
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| Vol #:
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| 305
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C
303
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| American Academy of Pediatrics (AAP) & Society for Adolescent Medicine (SAM)
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| Vol #:
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| 39
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| C
304
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| National Partnership for Women & Families
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| Vol #:
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| 39
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| C
305
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| Texas Campaign for Emergency Contraception
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| Vol #:
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| 39
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| C
306
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| Emergency Contraception Access Campaign
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| Vol #:
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| 305
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| TS
1
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| National Campaign to Prevent Teen Pregnancy
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| Vol #:
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| 39
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| TS
2
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| National Latina Institute for Reproductive Health (NLIRH)
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| Vol #:
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| 39
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| TS
3
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| Physicians for Reproductive Choice and Health (PRCH)
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| Vol #:
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| 39
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| TS
4
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| National Family Planning and Reproductive Health Assn (NFPRHA)
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| Vol #:
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| 39
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| 2001P-0546
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| ANDA for Covera-HS
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| PDN
1
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| HF-22 to Morgan, Lewis & Bockius LLP
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| Vol #:
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| 3
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| 2003D-0385
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| Guidance for Industry: Comparability Protocols - Protein Drug Products and Biologic Products - Chemistry, Manufacturing, and Controls Information
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| C
7
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| The Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| C
7
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| Pamlab, LLC
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| Vol #:
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| 1
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| C
8
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| International Guai-Support Group Network
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| Vol #:
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| 1
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| C
9
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| International Guai-Support Group Network
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| Vol #:
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| 1
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| C
10
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| International Guai-Support Group Network
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| Vol #:
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| 1
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| 2003N-0338
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| Obesity
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| EC 95
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| Peaslee, Kindy
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| Vol #:
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| 7
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| EMC
40
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| Enig Associates, Inc
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| Vol #:
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| 7
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| EMC
41
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| Grocery Manufacturers of America
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| Vol #:
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| 7
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| TR 3
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| Transcript of the November 20,
2003 Meeting
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| Vol #:
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| 9
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| |
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| 2003N-0344
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| Consumer-Directed Promotion; Public Meeting
|
| |
|
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| C
3
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| National Assn of Boards of Pharmacy (NABP)
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| Vol #:
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| 3
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| |
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| |
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| C 25
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| Allison J. Maffucci
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| Vol #:
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| 3
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| C 26
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| Allison J. Maffucci
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| Vol #:
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| 3
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| C
27
|
| Exotic Pet and Bird Clinic
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| Vol #:
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| 3
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| C
28
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| Georgia Department of Natural
Resources (GADNR)
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| Vol #:
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| 3
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| C 29
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| Maureen C. McDonald
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| Vol #:
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| 3
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| C 30
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| Dianne James
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| Vol #:
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| 3
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| C 31
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| Robert G. Weiner
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| Vol #:
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| 3
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| C
32
|
| Form Letters
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| Vol #:
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| 4
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| |
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| 2003N-0422
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| Annual Stakeholder Meeting on the Implementation of MDUFMA Provisions
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| |
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| TS 1
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| AdvaMed
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| Vol #:
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| 1
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| |
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| TS
2
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| National Electronical Manufacturers Association
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| Vol #:
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| 1
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| |
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| TS
3
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| Center for Patient Advocacy
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| Vol #:
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| 1
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| |
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| TS
4
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| Center for Patient Advocacy
|
| Vol #:
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| 1
|
| |
|
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| 2003N-0456
|
| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
|
| |
|
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| C
1
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| Compressed Gas Assn (CGA)
|
| Vol #:
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| 1
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| |
|
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| 2003N-0470
|
| Preparation for ICH meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003: Public Meeting
|
| |
|
|
| TR
1
|
| Transcript of the November 3, 2003 meeting
|
| Vol #:
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| 2
|
| |
|
|
| 2003P-0270
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| Prohibit False and Misleading Labeling
|
| |
|
|
| LET
2
|
| HFS-800 to Compassion Over Killing, Inc
|
| Vol #:
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| 6
|
| |
|
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| 2003P-0278
|
| Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing od drugs
|
| |
|
|
| LET
1
|
| HFM-1 to Hyman, Phelps & McNamara
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| Vol #:
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| 1
|
| |
|
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| 2003P-0280
|
| Determine that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices
|
| |
|
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| LET
1
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| HFM-1 to Hyman, Phelps & McNamara, PC
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| Vol #:
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| 1
|
| |
|
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| 2003P-0398
|
| (ANDA) for Oral Capsule Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital 50 mmg/ Cafferine 40mg/ Acetaminophen 325mg
|
| |
|
|
| C
1
|
| King & Spalding, LLP
|
| Vol #:
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| 1
|
| |
|
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| 2003P-0469
|
| ANADA Suitability for Ivermectin Hard-Chew Anthelmintic for (non-food) Horses
|
| |
|
|
| PAV
1
|
| HFV-100 to Eugene G. Keller,RPh.,FACA
|
| Vol #:
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| 1
|
| |
|
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| 2003P-0523
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| ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses
|
| |
|
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| PAV
1
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| HFV-100 to Karen A. Sisson
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| Vol #:
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| 1
|
| |
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| 2003P-0530
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| Silicone Gel-filled Breast Implants
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|
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| C
1
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| Inamed Corporation (Inamed)
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| Vol #:
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| 1
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| |
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| CR
1
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| King & Spalding
|
| Vol #:
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| 1
|
| |
|
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| 2003P-0552
|
| ANADA for a generic new animal drug caroprofen
|
| |
|
|
| ACK
1
|
| HFA-305 to Jurox PTY, Limited
|
| Vol #:
|
| 1
|
| |
|
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| CP
1
|
| Jurox PTY, limited
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
| | | | | | | | |
| |
|
|
| ACK 1
|
| HFA-305 to Committee for Truth in Psychiatry
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
|
| Committee for Truth in Psychiatry
|
| Vol #:
|
| 1
|
|
| |
|
| 2003Q-0547
|
| Health Claim Notification: Whole Grains and Coronary Heart Disease
|
| |
|
|
| ACK
1
|
| HFS-306 to Kraft Foods North America, Inc
|
| Vol #:
|
| 2
|
| |
|
|
| HCN
1
Appendix
a, b, c,
d
|
| Kraft Foods North America, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| HCN
2
Attachment, Appendix
a, b, c, d
|
| Kraft Foods North America, Inc.
|
| Vol #:
|
| 3
|
| |
|
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| LET
1
|
| HFS-800 to National Academy of Science
|
| Vol #:
|
| 2
|
| |
|
|
| LET
2
|
| Kraft Foods North America, Inc.
|
| Vol #:
|
| 2
|
|
|
