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| Dockets Entered
On October 31, 2003
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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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000P-0685
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| Revise of Yogurt Standards
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003D-0451
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| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: West Nile Virus Serological Assay
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| 2003N-0338
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| Obesity
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| 2003N-0341
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| Requirements for Submission of In Vivo Bioequivalence Data
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003N-0486
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| Determination That Pipracil (Piperacillin Sodium) 2-Gram, 3-Gram, and 4-Gram Vials Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0450
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| De Novo Petition for West Nile Virus IgM Capture ELISA
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| 2003P-0505
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| ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11404
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 87
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4069
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| Nancy Garvin
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| Vol #:
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| 514
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| EMC 4070
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| Meg O'Neill
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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 480
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| Barb Wilkie
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| Vol #:
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| 514
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| EMC 481
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| Barb Wilkie
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| Vol #:
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| 514
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| EMC
482
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| Cancer Research Center of America, Inc.
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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 574
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| Roger Gonzalez
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| Vol #:
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| 32
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| EMC 575
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| Heather McDowell
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| Vol #:
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| 32
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| EMC 576
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| Amy Gotwals
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| Vol #:
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| 32
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| EMC 577
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| Kathy Nicholson
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| Vol #:
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| 32
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| EMC 578
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| Judy Geagan
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| Vol #:
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| 32
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| EMC 579
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| Keith Johns
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| Vol #:
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| 32
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| EMC 580
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| Kenneth Jacobie
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| Vol #:
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| 32
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| EMC 581
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| Terry Jarrard-Dimond
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| Vol #:
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| 32
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| EMC 582
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| Amy Chesal
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| Vol #:
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| 32
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| EMC 583
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| Elaine Fischer
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| Vol #:
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| 32
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| 2000P-0685
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| Revise of Yogurt Standards
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| EMC 26
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| Diana Moore
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| Vol #:
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| 1
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| NAP
2
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| FDA
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| Vol #:
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| 1
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| NAL
1
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| FDA
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| Vol #:
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| 15
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| SS
1
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| Supporting Statement
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| Vol #:
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| 15
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| NAL
1
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| FDA
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| Vol #:
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| 17
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| SS
1
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| Supporting Statement
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| Vol #:
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| 17
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| EMC
2
Attachment
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| European Federation of Pharmaceutical Industries and Assn (EFPIA)
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| Vol #:
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| 1
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| 2003D-0451
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| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: West Nile Virus Serological Assay
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| EMC
1
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| American Assn of Blood Banks (AABB)
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| Vol #:
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| 1
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| EMC
2
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| Blood Systems, Inc.
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| Vol #:
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| 1
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| EMC
3
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| EMC
4
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| Long Beach Memorial Medical Center
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| Vol #:
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| 1
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| EMC
5
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| America's Blood Centers (ABC)
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| Vol #:
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| 1
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| EMC
6
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| Armed Services Blood Program Office (ASBPO)
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| Vol #:
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| 1
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| EMC
7
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| San Diego Blood Bank (SDBB)
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| Vol #:
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| 1
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| EMC
8
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| European Pharmacopoeia (PhEur)
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| Vol #:
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| 1
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| 2003N-0338
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| Obesity
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| EMC 14
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| Charis Loveland
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| Vol #:
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| 1
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| EMC 15
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| Jack Yeager
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| Vol #:
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| 1
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| EMC 16
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| Dave and Julie Hicks
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| Vol #:
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| 1
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| 2003N-0341
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| Requirements for Submission of In Vivo Bioequivalence Data
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| EMC
7
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 2
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| 2003N-0486
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| Determination That Pipracil (Piperacillin Sodium) 2-Gram, 3-Gram, and 4-Gram Vials Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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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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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC
1
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| Sonus Hearing Healthcare
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| Vol #:
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| 1
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| EMC 2
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| Richard L. Riess, PhD
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| Vol #:
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| 1
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| 2003P-0450
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| De Novo Petition for West Nile Virus IgM Capture ELISA
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0505
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| ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
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| ACK 1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
A, B, C,
D
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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