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| Dockets Entered
On October 3, 2005
Table of Contents
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| Docket #
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| Title
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| 1995M-0394
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| Premarket approval of VasoSeal Vascular Hemostasis Device
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003D-0474
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| Draft Guidance Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36)
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| 2005P-0400
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| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| 2005P-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| 1995M-0394
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| Premarket approval of VasoSeal Vascular Hemostasis Device
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| AAV 1
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| Datascope Corp
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| Vol #:
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| 1
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
293
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| Stragen Pharma SA
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| Vol #:
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| 228
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| RPT
294
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| L Lee
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| Vol #:
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| 230
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| RPT
295
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| L Lee
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| Vol #:
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| 230
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| RPT
296
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| Global Cancer Strategies Ltd
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| Vol #:
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| 231
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16577
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 149
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| 2003D-0474
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| Draft Guidance Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36)
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| EC
1
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| International-Planners.com
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| Vol #:
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| 1
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| EC
1
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| New Hampshire Animal Rights League
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 167
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| L. Hecke
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| Vol #:
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| 39
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| C
168
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| HerbaSway Laboratories, LLC
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| Vol #:
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| 39
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| EC 551
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| Mr. Kimber Nelson
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| Vol #:
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| 6
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| EC 552
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| Dr. Jonathan Ehrlich
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| Vol #:
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| 6
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| EREG
23
Attachment
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| Generation Life
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| Vol #:
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| 6
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| NHC
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| C
1
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| Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005P-0400
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| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| ACK 1
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| HFA-305 to Ms. Donna Ricks
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| Vol #:
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| 1
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| 2005P-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| EC 1
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| Miss. l Slitt
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| Vol #:
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| 6
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| EC 2
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| Dr. Lillian Beard
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| Vol #:
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| 6
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| EC 3
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| Mead Johnson
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| Vol #:
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| 5
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