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| Dockets Entered
On March 31, 2005
Table of Contents
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| Docket #
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| Title
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0317
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| Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products
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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-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| 2005N-0097
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| 2005V-0126
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| Projector for a Laser Light Show
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7474
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| R Willgerodt
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| Vol #:
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| 319
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| EMC 3163
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| D Doinakis
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| Vol #:
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| 261
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC
444
Attachment
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| Calorie Control Council
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| Vol #:
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| 7
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| EMC 445
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| Dr B Martini D Hum
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| Vol #:
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| 7
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| 2003D-0317
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| Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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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 709
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| J Anderson
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| Vol #:
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| 9
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| EMC 710
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| T
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| Vol #:
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| 9
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| EMC 711
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| unsigned
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| Vol #:
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| 9
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| EMC 712
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| G
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| Vol #:
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| 9
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| EMC 713
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| K Sullivan
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| Vol #:
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| 9
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| EMC 714
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| J Solvason
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| Vol #:
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| 9
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| EMC 715
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| R Byrnes
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| Vol #:
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| 9
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| | | | | | | | |
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| EMC 716
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| E Goodrich & C Yannayon
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| Vol #:
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| 9
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| EMC 717
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| K Bogetich
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| Vol #:
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| 9
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1564
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| A Sumrall
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| Vol #:
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| 22
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| EMC
2
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| Teva Pharmaceutical Industries Ltd
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| Vol #:
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| 1
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| EMC 13
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| B Sachau
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| Vol #:
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| 2
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| ACK
2
Mislabeled as ack1
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| HFA-305 to GlaxoSmithKline
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| Vol #:
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| 1
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| PSA
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| EMC 7
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| Debbie
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| Vol #:
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| 1
|
|
|
|
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
|
|
|
|
|
| ACK
2
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| HFA-305 toGlaxoSmithKline
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| Vol #:
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| 1
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| PSA
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2005N-0097
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0076
|
| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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|
|
|
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| SUP
1
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| B Van Rooyan
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| Vol #:
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| 1
|
|
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| 2005P-0127
|
| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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|
|
|
|
| CP
1
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| Aventis Pharmaceuticals, inc.
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| Vol #:
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| 1
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|
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| 2005V-0126
|
| Projector for a Laser Light Show
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|
|
|
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| ACK
1
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| HFA-305 to Endo & Son
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| Vol #:
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| 1
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| VAR
1
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| Endo & Son
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| Vol #:
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| 1
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