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| Dockets Entered
On June 30, 2005
Table of Contents
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| Docket #
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| Title
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| 2001N-0275
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| Performance standard for Diagnostic X-Ray Systems & Major Co
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| 2003F-0370
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| Unilever United States, Inc.; Filing of Food Additive Petition (FAP No. 3A4746)
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2004N-0515
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2004N-0558
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| Agency Information Collection Activities; Submission for Office
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| 2004P-0295
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| To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
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| 2004P-0390
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| ANDA Suitability for Doxycycline Hyclate Tablets, 75mg and 100mg
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| 2005D-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| 2001N-0275
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| Performance standard for Diagnostic X-Ray Systems & Major Co
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| NAL
1
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| FDA
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| Vol #:
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| 4
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| SS
1
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| Supporting Statement
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| Vol #:
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| 4
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2003F-0370
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| Unilever United States, Inc.; Filing of Food Additive Petition (FAP No. 3A4746)
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| NFR
1
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| FDA
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| 1
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| GDL
2
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| Guideline
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| 1
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| NAD
2
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| FDA
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| 1
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| RPT
1
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| Draft Drug-Diagnostic Co-Development Concept Paper
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| 1
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| 2004N-0515
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| 1
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| 2004N-0558
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| Agency Information Collection Activities; Submission for Office
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| N
2
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| FDA
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| 1
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| 2004P-0295
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| To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
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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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| 2004P-0390
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| ANDA Suitability for Doxycycline Hyclate Tablets, 75mg and 100mg
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| WDL
1
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| Lachman Consultant Services Inc
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| Vol #:
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| 1
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| LET
7
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| Nutrition 21 Inc
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| Vol #:
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| 11
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| LET
8
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| The Solae Company
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| Vol #:
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| 9
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| LET
6
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| H J Heinz Company
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| Vol #:
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| 16
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| LET
7
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| American Longevity Inc
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| Vol #:
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| 16
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| 2005D-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| GDL
2
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| Guideline
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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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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| RC
1
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| Aventis Pharmaceuticals Inc
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| Vol #:
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| 2
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