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| Dockets Entered
On October 5, 2004
Table of Contents
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| Docket #
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| Title
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| 1989V-0516
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| Laser Light Show Re: Omnichrome Laser
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| 1992V-0495
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| Laser Light Show
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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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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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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-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0413
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| Hyrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg combination drug product is suitable for submision as a ANDA
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| 2003P-0518
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| Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus)
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004D-0414
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| FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0196
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| ANDA for ribavirin, USP tablets in stengths of 400 mg and 600mg
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| 2004P-0213
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| ANDA Suitability for Pravastatin Sodium Tablets 60mg
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| 2004P-0216
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| ANDA Suitability for Pravastatin Sodium Tablets 30 mg
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| 2004P-0219
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| ANDA Suitability for Doxycycline Monohydrate Capsules, 150mg
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| 2004P-0280
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| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
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| 2004P-0281
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| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
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| 2004P-0282
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| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
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| 2004P-0451
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| ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets
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| 1989V-0516
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| Laser Light Show Re: Omnichrome Laser
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| VRA
8
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| HFZ-300 to Mr. Faith's Sound and Light Inc.
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| Vol #:
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| 1
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| 1992V-0495
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| Laser Light Show
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| VRA
4
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| HFZ-300 5o Dooley's Incorporated dba McMurphy's Sports Cafe
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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
14619
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| Dragon Herbs
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| Vol #:
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| 128
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| LET
14620
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| Dragon Herbs
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| Vol #:
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| 128
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| LET
14621
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| Dragon Herbs
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| Vol #:
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| 128
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| LET
14622
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| LifeEnhance
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| Vol #:
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| 128
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| LET
14623
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| Yu Shen Tang Chinese herbal Medicine, LLC
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| Vol #:
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| 128
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| LET
14624
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| Yu Shen Tang Chinese Herbal Medicine, LLC
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| Vol #:
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| 128
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| LET
14625
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| Yu Shen Tang Chinese Herbal Medicine, LLC
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| Vol #:
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| 128
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| LET
14626
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| Yu Shen Tang Chinese Herbal Medicine, LLC
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| Vol #:
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| 128
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| LET
14627
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| Yu Shen Tang Chinese Herbal Medicine, LLC
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| Vol #:
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| 128
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| LET
14628
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| Yu Shen Tang Chinese Herbal Medicine,
LLC
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| Vol #:
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| 128
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| LET
14629
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| Pure Encapsulations, Inc.
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| Vol #:
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| 128
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| LET
14630
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| Enzymatic Therapy
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| Vol #:
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| 128
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| LET
14631
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| Enzymatic Therapy
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| Vol #:
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| 128
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| LET
14632
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| Enzymatic Therapy
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| Vol #:
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| 128
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| LET
14633
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| American BioHealth Group
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| Vol #:
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| 128
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| LET
14634
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| Performance Labs, Inc.
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| Vol #:
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| 128
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| LET
14635
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| Herbalife International of America, Inc.
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| Vol #:
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| 128
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| LET
14636
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| Herbalife International of America, Inc.
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| Vol #:
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| 128
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| LET
14637
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| Enzymatic Therapy
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| Vol #:
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| 128
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| LET
14638
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| Enzymatic Therapy
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| Vol #:
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| 128
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4270
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| M. Hermann
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| Vol #:
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| 320
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| EMC 4271
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| I. Mills
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| Vol #:
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| 320
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| EMC 4272
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| S. Clay
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| Vol #:
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| 320
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| EMC 4273
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| J. Kahl
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| Vol #:
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| 320
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| EMC 4274
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| L. Law
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| Vol #:
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| 320
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| EMC 4275
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| K. Call
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| Vol #:
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| 329
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| EMC 4276
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| B. Gallagher
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| Vol #:
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| 320
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| EMC 4277
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| J. Baldwin
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| Vol #:
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| 320
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| EMC 4278
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| N. Dollard
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| Vol #:
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| 320
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| EMC 10504
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| R. Skrebes
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| Vol #:
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| 294
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| EMC 10505
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| E. Capener
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| Vol #:
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| 294
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| EMC 10506
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| L. Kurland
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| Vol #:
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| 294
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| EMC 10507
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| J. Walker
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| Vol #:
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| 294
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| EMC 10508
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| K. Russel
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| Vol #:
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| 294
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| EMC 10509
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| J. Elliott
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| Vol #:
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| 294
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| EMC 10510
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| R. Pershing
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| Vol #:
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| 294
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1247
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| J. Cahill
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| Vol #:
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| 5
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 189
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| S. Veer
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| Vol #:
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| 3
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| MM
14
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| Meeting between FDA and California Fine Wine Alliance, & Congressman Henry Bonilla's Office
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| Vol #:
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| 30
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| EMC 2
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| B. Sachau
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| Vol #:
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| 1
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| EMC 3
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| B. Sachau
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| Vol #:
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| 1
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| GDL
2
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| Guidance
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| Vol #:
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| 3
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| NAD
2
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| FDA
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| Vol #:
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| 3
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| GDL
2
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| Guidance
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| Vol #:
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| 4
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| NAD
2
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| FDA
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| Vol #:
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| 4
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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 403
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| A. Mangan
|
| Vol #:
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| 9
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| EMC 404
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| B. Hazard
|
| Vol #:
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| 9
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| EMC 405
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| S. Wilkie
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| Vol #:
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| 9
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| EMC 406
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| K. Alderton
|
| Vol #:
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| 9
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| EMC 407
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| R. Gautier
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| Vol #:
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| 9
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| EMC 408
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| E. Lisciandro
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| Vol #:
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| 9
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| EMC 409
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| M. Fett
|
| Vol #:
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| 9
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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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| NFR
1
|
| FDA
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| Vol #:
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| 2
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|
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| LET
5
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| Abbott Laboratories
|
| Vol #:
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| 1
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|
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| 2003P-0413
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| Hyrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg combination drug product is suitable for submision as a ANDA
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2003P-0518
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| Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus)
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| PAV
1
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| HFD-1 to Covington & Burling (Counsel for Wyeth Pharmaceuticals)
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| Vol #:
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| 1
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| C
7
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| Oklahoma Blood Institute, Sylvan N Goldman Center
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| Vol #:
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| 1
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| 2004D-0414
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| FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
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| GDL
1
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| Guidance
|
| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| GDL
1
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| Guidance
|
| Vol #:
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| 1
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|
|
|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| GDL
1
Erratum
|
| Guidance
|
| Vol #:
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| 1
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|
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
|
|
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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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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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
|
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
|
|
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|
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| EMC 698
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| P. Dalton
|
| Vol #:
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| 10
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|
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| EMC 699
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| T. Hybl
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| Vol #:
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| 10
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|
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| EMC 700
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| S. Crawford
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| Vol #:
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| 10
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|
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| EMC 701
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| M. Fenton
|
| Vol #:
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| 10
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|
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| EMC 702
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| R. Retzlaff
|
| Vol #:
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| 10
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|
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|
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| EMC 703
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| M. Lok
|
| Vol #:
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| 10
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|
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|
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| EMC 704
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| Hallie
|
| Vol #:
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| 10
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|
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|
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| EMC 705
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| P. Green
|
| Vol #:
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| 10
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|
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|
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| EMC 706
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| B. Wallace
|
| Vol #:
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| 10
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|
| | | | | | | | |
|
|
|
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| 2004P-0213
|
| ANDA Suitability for Pravastatin Sodium Tablets 60mg
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services Inc
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0216
|
| ANDA Suitability for Pravastatin Sodium Tablets 30 mg
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0219
|
| ANDA Suitability for Doxycycline Monohydrate Capsules, 150mg
|
|
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc
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| Vol #:
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| 1
|
|
|
|
|
| 2004P-0280
|
| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
|
|
|
|
|
| C
1
|
| GlaxoSmithKline Consumer Healthcare, LP
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0281
|
| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
|
|
|
|
|
| C
1
|
| GlaxoSmithKline Consumer Healthcare LLC
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0282
|
| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
|
|
|
|
|
| C
1
|
| GlaxoSmithKline Consumer Healthcare LP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0451
|
| ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets
|
|
|
|
|
| ACK
1
|
| HFA-305 to NuTec Incorporated
|
| Vol #:
|
| 1
|
|
|
|
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| CP
1
|
| NuTec Incorporated
|
| Vol #:
|
| 1
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|
