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| Dockets Entered
On November 16, 2004
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed
Cattle Into The Food Supply
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| 1999P-2630
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| Establish a Daily Value
for "added sugars"
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2000N-1633
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| Reimportation of Imported
Food Products Refused Admission
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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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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| 2002N-0178
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| Canned Tomatoes Deviating
from Identity Standard
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| 2002N-0291
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| Proposal to Debar Baldev
Raj Bhutani;Notice of Opportunity
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| 2003D-0391
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| Guidance for Industry and FDA
Staff; Class II Special Controls Guidance Document: Dental Precious
Metal Alloys and Class II Special Controls Guidance Document: Dental
Base Metal Alloys
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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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| 2003P-0574
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| Regulatory limit for
Listeria monocytogenes in ready-to-eat foods that do not support its
growth
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| 2004D-0028
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| Draft Consumer Advisory regarding
Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004D-0352
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| Global Harmonization
Task Force, Study Groups 1 and 2; New Proposed Documents
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| 2004D-0377
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| International Conference
on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs
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| 2004F-0066
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| Filing of Food Additive
Petition (FAP 4A4754) Food Additives Permitted in Food on an Interim
Basis or in Contact With Food Pending Additional Study; Mannitol
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| 2004N-0179
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; New Animal Drug Application,
FDA Form 356 V, 21 CFR Part 514
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| 2004N-0355
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| Scientific Considerations
Related to Developing Follow-on Protein Products
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| 2004P-0051
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| Dyclone (dyclonine hydrochloride)
Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn
or withheld from sale for reasons other then safety or efficacy
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|
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| 2004P-0340
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| action on regulation
of generic transdermal fentanyl delivery system, and new product approvals
for transdermal fentanyl products
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| 2004P-0472
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| refuse final approval
to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current
proposed labeling
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| 2004P-0506
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| fentanyl transdermal
products reduce the potential for abuse of certain types of these products
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| 2004P-0507
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| ANADA for generic hyaluronate
sodium injectable solution
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| 2004P-0511
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| ANDA for Methacholine
Chloride 1280 mg/vial
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| 2004S-0233
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| Stimulating Innovation
in Medical Technologies
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| 2004V-0508
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| Projector for a Laser
Light Show
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
14745
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| Leiner Health Products
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| Vol #:
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| 129
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| LET
14746
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| Leiner Health Products
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| Vol #:
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| 129
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| LET
14747
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| Leiner Health Products
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| Vol #:
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| 129
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| LET
14748
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| Planetary Formulas
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| Vol #:
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| 129
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| LET
14749
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| Source Naturals
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| Vol #:
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| 129
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| LET
14750
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| Vita Pharmica
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| Vol #:
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| 129
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| LET
14751
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| Enzymatic Therapy
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| Vol #:
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| 129
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| LET
14752
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| Enzymatic Therapy
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| Vol #:
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| 129
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| LET
14753
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| Enzymatic Therapy
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| Vol #:
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| 129
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| LET
14754
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| Lane Labs USA, Inc.
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| Vol #:
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| 129
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| | | | | | | | |
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| LET
14755
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| Pharmanex, LLC
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| Vol #:
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| 129
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| LET
14756
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| Lane Labs USA, Inc.
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| Vol #:
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| 129
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| LET
14757
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| Lane Labs USA, Inc.
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| Vol #:
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| 129
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| LET
14758
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| AdvoCare International, L.P.
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| Vol #:
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| 129
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| LET
14759
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| Earthrise Nutritionals, Inc.
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| Vol #:
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| 129
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| LET
14760
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14761
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7460
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| K. McCoy
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| Vol #:
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| 319
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| C 7461
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| K. Call
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| Vol #:
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| 319
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| EMC 4291
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| M. DeLuca
|
| Vol #:
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| 320
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 800
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| J. Doyle
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| Vol #:
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| 33
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| EMC 801
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| G. Taylor
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| Vol #:
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| 33
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| EMC 802
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| G. Taylor
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| Vol #:
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| 33
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 682
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| Bayer Corporation
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| Vol #:
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| 461
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| EXB 683
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| Bayer Corporation
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| Vol #:
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| 461
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| EXB 684
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| Bayer Corporation
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| Vol #:
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| 461
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| EXB 685
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| Bayer Corporation
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| Vol #:
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| 461
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| EXB 686
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| Bayer Corporation
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| Vol #:
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| 461
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| 2000N-1633
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| Reimportation of Imported Food Products Refused Admission
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| NWL
1
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| FDA
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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 11072
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| C. Audet
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| Vol #:
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| 296
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| EMC 11073
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| K. Giblin
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| Vol #:
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| 296
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| EMC 11074
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| C. Audet
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| Vol #:
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| 296
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| EMC 11075
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| K. Jiries
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| Vol #:
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| 296
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| EMC 11076
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| M. Pena
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| Vol #:
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| 296
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| EMC 11077
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| C. White
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| Vol #:
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| 296
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| EMC 11078
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| P. Campbell
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| Vol #:
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| 296
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| EMC 11079
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| T. Bauer
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| Vol #:
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| 296
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| EMC 11080
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| E. Nicholson
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| Vol #:
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| 296
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| EMC 11081
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| L. Strock
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| Vol #:
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| 296
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| | | | | | | | |
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| EMC 458
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| D. Reinman
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| Vol #:
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| 9
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| EMC 459
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| P. Shanahan
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| Vol #:
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| 9
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| EMC 460
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| N. Smith
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| Vol #:
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| 9
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| EMC 461
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| M. Turner
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| Vol #:
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| 9
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| EMC 462
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| S. Narayanan
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| Vol #:
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| 9
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| EMC 463
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| C. Thomas
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| Vol #:
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| 9
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| EMC 464
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| P. McFaddin
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| Vol #:
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| 9
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
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|
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| EMC
8
|
| Refrigerated Foods Association (RFA)
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| Vol #:
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| 2
|
|
|
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| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
|
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|
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| EC 9
|
| Slipper Rock University
|
| Vol #:
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| 1
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| 2004D-0352
|
| Global Harmonization Task Force, Study Groups 1 and 2; New Proposed Documents
|
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| C
1
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| Aventis Pharmaceuticals, Inc.
|
| Vol #:
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| 1
|
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| 2004D-0377
|
| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
|
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|
|
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|
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| C
3
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| Council on Radionuclides and Radiopharmaceuticals (CORAR) and the Medical Imaging Contrast Age
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| Vol #:
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| 1
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| EC 4
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| Mrs. Alison Bowers
|
| Vol #:
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| 1
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| EC
5
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| GlaxoSmithKline
|
| Vol #:
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| 1
|
|
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| 2004F-0066
|
| Filing of Food Additive Petition (FAP 4A4754) Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
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| 2004N-0179
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; New Animal Drug Application, FDA Form 356 V, 21 CFR Part 514
|
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|
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| EMC 1
|
| B. Sachau
|
| Vol #:
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| 1
|
|
|
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| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
|
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| EC
11
|
| Novartis Pharmaceuticals Corporation
|
| Vol #:
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| 1
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| EMC
3
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| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
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| 1
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| EMC
4
Attachment
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0051
|
| Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy
|
|
|
|
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| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0340
|
| action on regulation of generic transdermal fentanyl delivery system, and new product approvals for transdermal fentanyl products
|
|
|
| C
2
|
| Eon Labs, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
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| | | | | | | | |
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| C
2
|
| Drug Free Schools Coalition
|
| Vol #:
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| 1
|
|
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|
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| 2004P-0506
|
| fentanyl transdermal products reduce the potential for abuse of certain types of these products
|
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| ACK
1
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| Alza Corporation
|
| Vol #:
|
| 1
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| CP
1
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| Alza Corporation
|
| Vol #:
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| 1
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|
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| 2004P-0507
|
| ANADA for generic hyaluronate sodium injectable solution
|
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|
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| ACK
1
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| HFA-305 to Bioniche Animal Health USA, Inc.
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| Vol #:
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| 1
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| CP
1
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| Bioniche
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| Vol #:
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| 1
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| 2004P-0511
|
| ANDA for Methacholine Chloride 1280 mg/vial
|
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| ACK
1
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| HFA-305 to ACIC Fine Chemicals, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment 1,
2
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| ACIC Fine Chemicals, Inc.
|
| Vol #:
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| 1
|
|
|
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| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| C
19
|
| Infectious Diseases Society of America (IDSA)
|
| Vol #:
|
| 2
|
|
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|
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| 2004V-0508
|
| Projector for a Laser Light Show
|
|
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|
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| ACK
1
|
| HFA-305 to Jake Barner Studios
|
| Vol #:
|
| 1
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| VAR
1
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| Jake Barner Studios
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| Vol #:
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| 1
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