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| Dockets Entered
On March 17, 2004
Table of Contents
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| Docket #
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| Title
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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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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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004P-0128
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| ANADA for clavamox (amoxicillin trihydrate/clavulanate potassium) tablets for dogs and cats
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| 2004P-0129
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| Modify Current Regulation Governing Structure/function Claims, 21 CFR Pt. 101.93
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| 2004P-0130
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| ANADA for AMOXI-TABS (amoxicillin) for dogs and cats
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| 2004P-0131
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| ANDA Suitability for Tofin (tobramycin for Inhalation)
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| MM
1
Tab 1, Tabs
2-7
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| Alcavis International, Inc.
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| Vol #:
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| 8
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| MM
7
Tab 1,Tabs
2-7
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| Alcavis International, Inc.
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| Vol #:
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| 200
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| |
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13293
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| Body Wise International, Inc.
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| Vol #:
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| 109
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| |
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| LET
13294
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 109
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| LET
13295
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 109
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| LET
13296
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 109
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| LET
13297
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 109
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| |
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| LET
13298
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 109
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| |
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| LET
13299
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 109
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| |
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| LET
13300
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| Body Wise International, Inc.
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| Vol #:
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| 109
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| |
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| LET
13301
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| Source Naturals
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| Vol #:
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| 109
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| |
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| LET
13302
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| Aboca USA, Inc.
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| Vol #:
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| 109
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| |
|
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| LET
13303
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| Aboca USA, Inc.
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| Vol #:
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| 109
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| |
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| LET
13304
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| LET
13305
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13306
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13307
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
|
|
| LET
13308
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
|
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| LET
13309
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| Aboca USA, Inc.
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| Vol #:
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| 110
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|
| | | | | | | | |
| |
|
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| LET
13310
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13311
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13312
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
|
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| LET
13313
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
|
|
| LET
13314
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13315
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13316
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13317
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
|
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| LET
13318
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| Aboca USA, Inc.
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| Vol #:
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| 110
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| |
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| LET
13319
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| Your Vitamins
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| Vol #:
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| 110
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| |
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| LET
13320
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| Natural Organics inc.
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| Vol #:
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| 110
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| |
|
|
| LET
13321
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| Natural Organics Inc.
|
| Vol #:
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| 110
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| |
|
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| LET
13322
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| Natural Organics Inc.
|
| Vol #:
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| 110
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| |
|
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| LET
13323
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| Your Vitamins
|
| Vol #:
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| 110
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| |
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| |
|
|
| C 12726
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| John Otterberg
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| Vol #:
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| 789
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| |
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| C 12727
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| Gwendolyn Attwood
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| Vol #:
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| 789
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| C 12728
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| Pat Tyler
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| Vol #:
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| 789
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| |
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| C 12729
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| Daniel Shiverly
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| Vol #:
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| 789
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| C 12730
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| Jennifer Medley
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| Vol #:
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| 789
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| EMC 5798
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| Jody Spear
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| Vol #:
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| 789
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| EMC 5799
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| Maya Weinstein
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| Vol #:
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| 789
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| EMC 5800
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| Cathy Mackey
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| Vol #:
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| 789
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| EMC 5801
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| Cathy Mackey
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| Vol #:
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| 789
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| EMC 5802
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| Cathleen Branich
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| Vol #:
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| 789
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| EMC 5803
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| Andrew Heydt
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| Vol #:
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| 789
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| EMC 5804
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| Scott Wolf
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| Vol #:
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| 789
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| |
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|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
|
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| EMC 4626
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| M. A. Anderews
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| Vol #:
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| 169
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| EMC 4627
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| N. Mans
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| Vol #:
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| 169
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| EMC 4628
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| E. Schulman
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| Vol #:
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| 169
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| EMC 4629
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| D. Pietrantonio
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| Vol #:
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| 169
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| EMC 4630
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| C. Weatherford
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| Vol #:
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| 169
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| EMC 4631
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| Lizsallen
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| Vol #:
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| 169
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| EMC 4632
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| P. Spray
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| Vol #:
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| 169
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| EMC 4633
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| J. D. Woodward
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| Vol #:
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| 169
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| EMC 4634
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| C. Brendler
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| Vol #:
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| 169
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| EMC 4635
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| k. Mossgraber
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| Vol #:
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| 169
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| EMC 4636
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| G. Diepenbrock
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| Vol #:
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| 169
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| EMC 4637
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| J. Richards
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| Vol #:
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| 169
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| EMC 4638
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| K. Olson
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| Vol #:
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| 169
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| EMC 4639
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| A. B. Mitchell
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| Vol #:
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| 169
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| EMC 4640
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| D. Beaton
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| Vol #:
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| 169
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| EMC 4641
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| K. Conrad
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| Vol #:
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| 169
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| EMC 4642
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| M. Shooner
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| Vol #:
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| 169
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| EMC 4643
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| S. Pollesch
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| Vol #:
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| 169
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| EMC 4644
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| K. Kelly-Hoffman
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| Vol #:
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| 169
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| EMC 4645
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| Debbi V.
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| Vol #:
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| 169
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| EMC 4646
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| R. Wrightson
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| Vol #:
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| 169
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| EMC 4647
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| Richard A Dilley
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| Vol #:
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| 169
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| EMC 4648
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| G. Brookman
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| Vol #:
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| 169
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| EMC 4649
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| A. Stutz
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| Vol #:
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| 169
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| EMC 4650
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| M. C. Nigro
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| Vol #:
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| 169
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| EMC 4651
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| Butterfly
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| Vol #:
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| 169
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| EMC 4652
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| C. Scalzo
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| Vol #:
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| 169
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| EMC 4653
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| C. Nordgsaard
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| Vol #:
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| 169
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| EMC 4654
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| B. L. Hite
|
| Vol #:
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| 169
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| |
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| EMC 4655
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| J. MacCallum
|
| Vol #:
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| 169
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| EMC 4656
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| K. Nesslar
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| Vol #:
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| 169
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| EMC 4657
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| M.L. Jackson-Miller
|
| Vol #:
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| 169
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| |
|
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| EMC 4658
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| L. Farrell
|
| Vol #:
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| 169
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| |
|
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| EMC 4659
|
| B. Lindstrom
|
| Vol #:
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| 169
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| |
|
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| EMC 4660
|
| M. Leitch
|
| Vol #:
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| 169
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| |
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| EMC 4661
|
| E. Edinger
|
| Vol #:
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| 169
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| |
|
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| EMC 4662
|
| J. Martinez
|
| Vol #:
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| 169
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| |
|
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| EMC 4663
|
| M. & B. Boelling
|
| Vol #:
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| 169
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| |
|
|
| EMC 4664
|
| W. A. White
|
| Vol #:
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| 169
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| |
|
|
| EMC 4665
|
| S. Winner
|
| Vol #:
|
| 169
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| |
|
|
| EMC 4666
|
| G. Geoghagan
|
| Vol #:
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| 169
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| |
|
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| EMC 4667
|
| G. Schoerlucke
|
| Vol #:
|
| 169
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| |
|
|
| EMC 4668
|
| F. Kadagian
|
| Vol #:
|
| 169
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| |
|
|
| EMC 4669
|
| M. Stenseth
|
| Vol #:
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| 169
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|
| | | | | | | |
| |
|
|
| EMC 4670
|
| K. O'Grady
|
| Vol #:
|
| 169
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| |
|
|
| EMC 4671
|
| K. Phipps
|
| Vol #:
|
| 169
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| |
|
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| EMC 4672
|
| G. Ayres
|
| Vol #:
|
| 169
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| |
|
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| EMC 4673
|
| A. Craig
|
| Vol #:
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| 169
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| |
|
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| EMC 4674
|
| J. D. Janes
|
| Vol #:
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| 169
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| |
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| EMC 4675
|
| M. Wiggin
|
| Vol #:
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| 169
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| |
|
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| EMC 4676
|
| J. D. Janes
|
| Vol #:
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| 169
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| |
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| EMC 4677
|
| D. B. Reynolds
|
| Vol #:
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| 169
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| |
|
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| EMC 4678
|
| D. B. Reynolds
|
| Vol #:
|
| 169
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| |
|
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| EMC 4679
|
| R. Vandervennet
|
| Vol #:
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| 169
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| |
|
|
| EMC 4680
|
| M. Brister
|
| Vol #:
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| 169
|
| |
|
|
| EMC 4681
|
| H. & S. Van Asch Wyck
|
| Vol #:
|
| 169
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| |
|
|
| EMC 4682
|
| Dr. L. Pina
|
| Vol #:
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| 169
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| |
|
|
| EMC 4683
|
| J. Markessinis
|
| Vol #:
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| 169
|
| |
|
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| EMC 4684
|
| Rev. D. A. Ames
|
| Vol #:
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| 169
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| |
|
|
| EMC 4685
|
| A. Glavas
|
| Vol #:
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| 169
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| |
|
|
| EMC 4686
|
| J. Lewis
|
| Vol #:
|
| 169
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| |
|
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| EMC 4687
|
| B. Purnell
|
| Vol #:
|
| 169
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| |
|
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| EMC 4688
|
| M. Diamond
|
| Vol #:
|
| 169
|
| |
|
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| EMC 4689
|
| A. Warn
|
| Vol #:
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| 169
|
| |
|
|
| EMC 4690
|
| C. L. Floyd
|
| Vol #:
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| 169
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| |
|
|
| EMC 4691
|
| R. Ryan
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4692
|
| W. Brann
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4693
|
| M. Holik
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4694
|
| J. C. Wright
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4695
|
| L. Alldrin
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4696
|
| R. Burnett
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4697
|
| A. Dixon
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4698
|
| K. Eich
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4699
|
| M. J. Battaglia
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4700
|
| A. Crawford
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4701
|
| S. Fremont
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4702
|
| V. DeMara
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4703
|
| R. Marquard
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4704
|
| S. Livingston
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4705
|
| K. Philipp
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4706
|
| T. Buchen
|
| Vol #:
|
| 169
|
|
| | | | | | | | |
| |
|
|
| EMC 4707
|
| V. Gould
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4708
|
| C. Larsen
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4709
|
| M. Henderson
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4710
|
| Mr. Jean Rinaldo
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4711
|
| D. W. Craven
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4712
|
| A. Wilson
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4713
|
| T. B. Zissu
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4714
|
| K. Davis
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4715
|
| D. Azbell
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4716
|
| R. Brown
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4717
|
| B. Roman
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4718
|
| S. Phipps
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4719
|
| F. & H. Reily
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4720
|
| G. Humphrey
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4721
|
| S. Pinsley
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4722
|
| R. Breidenbach
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4723
|
| K. Rossein
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4724
|
| A. Blevins
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4725
|
| S. Peskoe
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4726
|
| K. Elliott
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4727
|
| B. Schuler
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4728
|
| T. Browne
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4729
|
| M. Halonen
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4730
|
| B. Winter
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4731
|
| D. Rippe
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4732
|
| G. McCullough
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4733
|
| B. Stone
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4734
|
| D. O'Donoghue
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4735
|
| B. C. Reed
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4736
|
| M. Savageau
|
| Vol #:
|
| 169
|
| |
|
|
| EMC 4737
|
| E. Bloss
|
| Vol #:
|
| 169
|
| |
|
|
| 2003E-0419
|
| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
| |
|
|
| EMC 267
|
| S. Mattison
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| EMC 268
|
| K. Paddock
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 269
|
| S. Theisen
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 270
|
| J. Moretz
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 271
|
| S. Morgan
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 272
|
| C. Costigan
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 273
|
| P. Chandler
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 274
|
| R. Mercury
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 275
|
| L. Catapano
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 276
|
| B. Scharold
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 277
|
| L. Catapano
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 278
|
| C. Hoekenga
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 279
|
| C. Hatcher
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 280
|
| S. Walker
|
| Vol #:
|
| 2
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0128
|
| ANADA for clavamox (amoxicillin trihydrate/clavulanate potassium) tablets for dogs and cats
|
| |
|
|
| ACK 2
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0129
|
| Modify Current Regulation Governing Structure/function Claims, 21 CFR Pt. 101.93
|
| |
|
|
| ACK 1
|
| HFA-305 to American Longevity, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| American Longeviry, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0130
|
| ANADA for AMOXI-TABS (amoxicillin) for dogs and cats
|
| |
|
|
| ACK 1
|
| HFA-305 to Smart Drug Systems Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Generic
Label
Pioneer Label
|
| Smart Drug Systems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0131
|
| ANDA Suitability for Tofin (tobramycin for Inhalation)
|
| |
|
|
| ACK 1
|
| HFA-305 to SourceCF, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Continued
|
| SourceCF, Inc.
|
| Vol #:
|
| 1
|
|
|
