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Dockets
Entered On July 3, 2003
Table
of Contents
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Docket #
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Title
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1981N-0033P
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Antiplaque & Antiplaque-Related Claims
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1991N-0384H
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Nutrient Content Claims, Definition of Term:
Healthy
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1995N-0309
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CGMPs for the Production of Infant Formula
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1996P-0500
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Amend "Healthy" Definition re: Sodium
Levels
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1998P-0610
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Convert
Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
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1999D-1738
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Bioavilability & Bioequivalence Studies for
Nasal Aerosols
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2000D-1384
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Physical Examination of Surgeons' &/or Patient
Exam Gloves
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2000N-1571
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Enrofloxacin for Poultry: Opportunity for Hearing
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2001D-0435
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ICH Technical Requirements: Registration of
Pharmaceuticals
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2001P-0075
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Switch Status of Emergency Contraceptives from Rx
to OTC
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2002D-0526
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Guidance for drug Chemistry, Manufacturing,
Control Info.
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2002N-0204
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Bar Code Label Requirements for human drug
products
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2002N-0434
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Withdrawel of Certain Proposed rules & other
propose action
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2003D-0061
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Comparability Protocols Chemistry Manufacturing
and controls
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2003N-0169
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|
Dental Amalgam; Request for Information
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2003P-0029
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|
Remove metered-dose inhalers (MDI) containing
moiety albuter
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2003P-0214
|
|
Correct the listing of Quinidine extended-release
tablets in Orange Book
|
|
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2003P-0270
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|
Prohibit False and Misleading Labeling
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|
Contents
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1981N-0033P
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Antiplaque
& Antiplaque-Related Claims
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EMC 1
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Boston University Goldman
School of Dental Medicine
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Vol #:
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1
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1991N-0384H
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Nutrient Content Claims, Definition of Term:
Healthy
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C 126
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AARP
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Vol #:
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10
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1992N-0391
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Analysis of Adverse Reactions to Monosodium
Glutamate (MSG)
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EMC 6
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|
Donald C. Maguire
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Vol #:
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18
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1995N-0304
|
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Ephedrine Alkaloids: Reports of Adverse Events;
Availability
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EMC 806
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Kevin
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Vol #:
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375
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EMC 807
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John Jubilee
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Vol #:
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375
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EMC 808
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Harry Casari
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Vol #:
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375
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EMC 809
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Gretchen Harvey
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Vol #:
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375
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1995N-0309
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CGMPs for the Production of Infant Formula
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C 20
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California WIC Program
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Vol #:
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9
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1996N-0417
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CGMP in Mfg. Packing or Holding Dietary
Supplements
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EMC 26
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Barbara Mauriello
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Vol #:
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17
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EMC 27
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Todd Luger, L.Ac
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Vol #:
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17
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EMC 28
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Catherine Hemenway, L.Ac
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Vol #:
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17
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1996P-0500
|
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Amend "Healthy" Definition re:
Sodium Levels
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C 36
|
|
AARP
|
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Vol #:
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13
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|
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|
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1998P-0610
|
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Convert
Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
|
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EMC 90
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Wylma Davison
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Vol #:
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5
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EMC 91
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Washington Legal Foundation (WLF)
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Vol #:
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5
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1999D-1738
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Bioavilability & Bioequivalence Studies
for Nasal Aerosols
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C 21
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AstraZeneca, LP
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Vol #:
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2
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1999N-4282
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Biotechnology in the Year 2000 and Beyond; Public
Meetings
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EMC 4021
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Daniel Clayton
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Vol #:
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514
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EMC 4022
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Lisa Lisa
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Vol #:
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514
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EMC 4023
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Andrea Orzoff
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Vol #:
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514
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EMC 4024
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Sonia Fletcher
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Vol #:
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514
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1999P-1340
|
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Declared Eternity eau de Parfum Misbranded
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EMC 454
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Shaun Moersfelder
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Vol #:
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21
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1999P-2630
|
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Establish a Daily Value for "added
sugars"
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EMC 481
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Elaine Prendergast
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Vol #:
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32
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2000D-1384
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Physical Examination of Surgeons' &/or
Patient Exam Gloves
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EMC 1
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|
Malaysian Rubber Glove Manufacturers Assn (MARGMA)
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Vol #:
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1
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2000D-1598
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Voluntary Labeling for Bioengineered Foods
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EMC 12010
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P.J. Perkins
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Vol #:
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574
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EMC 12011
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Tracy Jackson
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Vol #:
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574
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EMC 12012
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Erik Callaway
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Vol #:
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574
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2000N-1571
|
|
Enrofloxacin for Poultry: Opportunity for
Hearing
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|
|
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MO 51
|
|
Bayer Corporation
|
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Vol #:
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378
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2001D-0435
|
|
ICH Technical Requirements: Registration of
Pharmaceuticals
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|
|
|
C 10
|
|
AstraZeneca, LP
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Vol #:
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1
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2001N-0256
|
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Use of Opiate Analgesics in Various Patient
Population inclu
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EMC 199
|
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Rhonda Blair
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Vol #:
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2
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2001P-0075
|
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Switch Status of Emergency Contraceptives from
Rx to OTC
|
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EMC 451
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Diana Toto
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Vol #:
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39
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EMC 452
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Allmand Allen
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Vol #:
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39
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EMC 453
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Shell Exploration & Production Company
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Vol #:
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39
|
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|
|
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2002D-0526
|
|
Guidance for drug Chemistry, Manufacturing,
Control Info.
|
|
|
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C 14
|
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Baxter Healthcare Corporation (Baxter)
|
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Vol #:
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1
|
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2002N-0204
|
|
Bar Code Label Requirements for human drug
products
|
|
|
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EMC 203
|
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MercuryMD, Inc.
|
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Vol #:
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16
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Attachments
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2002N-0275
|
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Bioterrorism Preparedness; Administrative
Detention
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EMC 22
|
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Irish Exporters Assn (IEA)
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Vol #:
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5
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EMC 23
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Washington State University
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Vol #:
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5
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Attachments
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EMC 24
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HFS-565
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Vol #:
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5
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Attachments 1, 2, 3, 4, 5, 6, 7, 8
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EMC 25
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Royal Thai Embassy
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Vol #:
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5
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EMC 26
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Ministry of Trade of Vietnam
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Vol #:
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5
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2002N-0276
|
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Bioterrorism Preparedness;Registration of Food
Facilities
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EMC 88
|
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Irish Exporters Assn (IEA)
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Vol #:
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13
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EMC 89
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Royal Thai Embassy
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Vol #:
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13
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EMC 90
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Ministry of Trade of Vietnam
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Vol #:
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13
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EMC 91
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USDA
|
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Vol #:
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13
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EMC 92
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USDA
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Vol #:
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13
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2002N-0277
|
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Bioterrorism; Establishment & Maintenance of
Records
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C 36
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National Coffee Assn (NCA)
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Vol #:
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8
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C 37
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National Nutritional Foods Assn
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Vol #:
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8
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C 38
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Color Pigments Manufacturers Association, Inc.
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Vol #:
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8
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EMC 28
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Australian Wine And Brandy Corporation (AWBC)
|
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Vol #:
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8
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EMC 29
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HFS-565
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Vol #:
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8
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Attachment 1, 2, 3, 4, 5, 6, 7, 8
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EMC 30
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Ministry of Trade of Vietnam
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Vol #:
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8
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EMC 31
|
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Cataract Customhouse Brokerage, Inc.
|
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Vol #:
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8
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EMC 32
|
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Mead Johnson & Company
|
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Vol #:
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8
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2002N-0434
|
|
Withdrawal of Certain Proposed rules &
other propose action
|
|
|
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EXT 1
|
|
Arent Fox Kintner Plotkin & Kahn, PLLC
|
|
Vol #:
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1
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|
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2003D-0061
|
|
Comparability Protocols Chemistry
Manufacturing and controls
|
|
|
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C 11
|
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GlaxoSmithKline (GSK)
|
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Vol #:
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1
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2003D-0118
|
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Decorative Contact Lens (Import alert #86-10)
|
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C 36
|
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Keith Poindexter, O.D.
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Vol #:
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1
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C 37
|
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Maria Higgins Eger, O.D., F.A.A.O.
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Vol #:
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1
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C 38
|
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Timothy J. Barron, O.D.
|
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Vol #:
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1
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2003N-0169
|
|
Dental Amalgam; Request for Information
|
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|
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C 10
|
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Gabriel Rose Press
|
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Vol #:
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4
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SUP 7
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John Costa
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Vol #:
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4
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SUP 8
|
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Maths Berlin
|
|
Vol #:
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4
|
|
|
|
|
|
2003P-0029
|
|
Remove metered-dose inhalers (MDI) containing
moiety albuter
|
|
|
|
C 3
|
|
GlaxoSmithKline (GSK)
|
|
Vol #:
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1
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Attachment 1, 2
|
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|
|
|
2003P-0214
|
|
Correct the listing of Quinidine
extended-release tablets in Orange Book
|
|
|
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WDL 1
|
|
Mutual Pharmaceutical Company
|
|
Vol #:
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1
|
|
|
|
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2003P-0270
|
|
Prohibit False and Misleading Labeling
|
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|
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C 15
|
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Charmaine Curry
|
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Vol #:
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1
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C 16
|
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Patricia Lynch
|
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Vol #:
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1
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C 17
|
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Irene Korber
|
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Vol #:
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1
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C 18
|
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Caryn Servis
|
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Vol #:
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1
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C 19
|
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International Voice for Animals
|
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Vol #:
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1
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2003P-0291
|
|
Enforce the law and prevent unlaw sale of contact
lens
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C 4
|
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Vaughn Parfitt, O.D.
|
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Vol #:
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1
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Page Created July 7, 2003 jb
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