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| Dockets Entered
On March 29, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1998N-0046
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| Comprehensive List of Current Guidance Documents at FDA
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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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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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004P-0451
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| ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005FL-0434
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| 2005FL-0488
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| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| 2005N-0416
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| 2005N-0507
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| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
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| 2005N-0508
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding their Preferences for Public Health Notifications
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| 2005N-0510
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| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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| 2005P-0400
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| permission to Donna Ricks to continue using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 2005Q-0297
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| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006FL-0017
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| Food Allergen Labeling Notification for Purity Foods Vita Spelt
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| 2006N-0106
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| New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
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| 2006N-0118
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| Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
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| 2006P-0140
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| To withhold approval of any ANDA for a generic version of acitretin capsules
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| 1976N-0052N
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| OTC Nasal Decongestants
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| EMC 139
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| P. Whelan, MD, PhD
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| Vol #:
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| 77
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| EMC 60
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| P. Whelan, MD, PhD
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| Vol #:
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| 93
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| | | | | | | | |
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| 1998N-0046
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| Comprehensive List of Current Guidance Documents at FDA
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| N 11
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| FDA
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| Vol #:
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| 2
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7527
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| B. Blitz
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| Vol #:
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| 319
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| EMC 4395
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| J. Harker
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| Vol #:
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| 320
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| EMC 4396
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| K. Fendrich
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| Vol #:
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| 320
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| EMC 4397
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| S. Munt
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| Vol #:
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| 320
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| EMC 4398
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| M. Lok
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| Vol #:
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| 320
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| EMC 4399
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| M. O'Rourke
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| Vol #:
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| 320
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 21
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| M. Beaumont
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| Vol #:
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| 3
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 636
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| R. Mattingly
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| Vol #:
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| 24
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| EMC 637
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| C. Camera
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| Vol #:
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| 24
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| EMC 638
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| B. Worley
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| Vol #:
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| 24
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| EMC 639
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| B. Hollowell
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| Vol #:
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| 24
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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 1315
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| S. Reidy
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 620
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| Mission Possible International
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| Vol #:
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| 9
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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 1256
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| No signature
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| Vol #:
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| 12
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| EMC 1257
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| V. Cunningham
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| Vol #:
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| 12
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| EMC 1258
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| P. Pinholster
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| Vol #:
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| 12
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| C 43
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| Bed Safety Consulting, Inc.
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| Vol #:
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| 3
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| 2004P-0451
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| ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets
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| LET 1
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| HFD-600 to NuTec Incorporated
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| Vol #:
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| 1
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| C 11
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| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
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| Vol #:
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| 1
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| EMC 3
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| | | | | | | | |
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| 2005FL-0434
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| ANS 1
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| HF-21 to Ross Products Division, Abbott Laboratories
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| Vol #:
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| 3
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| 2005FL-0488
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| Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy
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| ANS 1
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| HF-21 to F & A Dairy of California, Inc
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| Vol #:
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| 1
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| C 4
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| FDA Ready Consulting
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| Vol #:
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| 1
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| EMC 11
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| W. Berko
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| Vol #:
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| 1
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005N-0416
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| ANS 1
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| HF-21 to Mead Johnson Nutritionals
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| Vol #:
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| 1
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| LET 2
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| HFS-004 to Mead Johnson Nutritionals
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| Vol #:
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| 1
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| 2005N-0507
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| Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005N-0508
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding their Preferences for Public Health Notifications
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2005N-0510
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| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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| C 9
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| Sanofi Pasteur, Inc.
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| Vol #:
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| 3
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| 2005P-0400
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| permission to Donna Ricks to continue using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| M 1
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| FDA/CDER
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EMC 526
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| J. Johnson
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| Vol #:
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| 76
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| EMC 527
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| E. Busch, PhD
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| Vol #:
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| 76
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| EMC 528
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| F. Wilhelmi
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| Vol #:
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| 76
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| EMC 529
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| P. Williford
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| Vol #:
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| 76
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| EMC 530
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| D. Pruitt
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| Vol #:
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| 76
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| EMC 531
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| B. Geikie
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| Vol #:
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| 76
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| EMC 532
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| L. SMith
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| Vol #:
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| 76
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| EMC 533
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| C. Church
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| Vol #:
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| 76
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| EMC 608
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| G. Russell
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| Vol #:
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| 76
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| EMC 609
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| B. Davis
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| Vol #:
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| 76
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| EMC 610
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| S. Morrow
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| Vol #:
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| 76
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| EMC 611
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| L. Woods
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| Vol #:
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| 76
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| EMC 612
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| N. Crist
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| Vol #:
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| 76
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| EMC 613
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| R. Mattingly
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| Vol #:
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| 76
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| EMC 614
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| J. Wagoner
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| Vol #:
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| 76
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| EMC 615
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| S. Vandegrift
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| Vol #:
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| 76
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| EMC 616
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| R. Schumacher
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| Vol #:
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| 76
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| EMC 617
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| C. Pritchard
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| Vol #:
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| 76
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| EMC 618
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| E. Scanlan
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| Vol #:
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| 76
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| EMC 619
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| S. Saikaly
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| Vol #:
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| 76
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| EMC 620
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| B. Wade
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| Vol #:
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| 76
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| EMC 621
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| B. Wade
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| Vol #:
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| 76
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| EMC 622
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| G. Molter
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| Vol #:
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| 76
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| EMC 623
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| G. Wiltse
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| Vol #:
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| 76
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| EMC 624
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| J. Wohlman
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| Vol #:
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| 76
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| EMC 625
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| S. Trivison
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| Vol #:
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| 76
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| EMC 626
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| M. Mizell
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| Vol #:
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| 76
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| EMC 627
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| D. Clark
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| Vol #:
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| 76
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| EMC 628
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| B. Lavigne
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| Vol #:
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| 76
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| EMC 629
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| D. Swanson
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| Vol #:
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| 76
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| EMC 630
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| J. Trowbridge
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| Vol #:
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| 76
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| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| SUP 3
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| Banner Pharmacaps Inc.
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| Vol #:
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| 1
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|
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| 2005Q-0297
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| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
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| LET 2
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| AAC Consulting Group
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| Vol #:
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| 5
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|
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| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 2
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| King Arthur Flour Company, Inc.
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| Vol #:
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| 1
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| C 3
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| Roman Meal Company
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| Vol #:
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| 1
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| 2006FL-0017
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| Food Allergen Labeling Notification for Purity Foods Vita Spelt
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|
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| ANS 1
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| HF-21 to Purity Foods, Inc.
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| Vol #:
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| 1
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| 2006N-0106
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| New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
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| EMC 1
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| C. Smith
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| Vol #:
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| 2
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