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| Dockets Entered
On March 30, 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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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare
Providers
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| 2001P-0145
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| Change the classification
of colonic irrigation systems
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| 2002D-0371
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| Human Dura Mater; Class II Special
Controls Guidance
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|
| 2002N-0278
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| Bioterrorism; Prior Notice of
Imported Food Shipments
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| 2003D-0570
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| Draft on the Clinical Evaluation
of Weight-Control Drugs
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|
| 2003N-0575
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| Agency Information Collection
Activities; Proposed Collection; Comment Request; 2004 National Tracking
Survey of Prescription Drug Information Provided to Patients
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| 2004D-0014
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| Guidance for Industry on Information
Program on Clinical Trials for Serious or Life-Threatening Diseases
and Conditions
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| 2004D-0117
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| International Conference
on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
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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on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological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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| 2004D-0124
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| Guidance for Industry: Animal
Drug User Fees and Fee Waivers and Reductions
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| 2004P-0152
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| ANDA Suitability for
Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths
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| 2004P-0153
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| ANDA Suitability for
Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg,
20 mg, and 30 mg.
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
13413
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13414
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13415
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13416
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13417
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| Phyto Pharmica Natural
Medicines
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| Vol #:
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| 111
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| LET
13418
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| Millennium Biotechnologies,
Inc.
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| Vol #:
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| 111
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| LET
13419
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| Millennium Biotechnologies,
Inc.
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| Vol #:
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| 111
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| LET
13420
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| Millennium Biotechnologies,
Inc.
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| Vol #:
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| 111
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| LET
13421
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| Synergy
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| Vol #:
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| 111
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| LET
13422
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| Herbal Source
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| Vol #:
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| 111
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| LET
13423
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| Herbal Source
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| Vol #:
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| 111
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| LET
13424
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| Herbal Source
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| Vol #:
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| 111
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| LET
13425
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13426
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13427
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13428
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13429
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13430
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13431
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| Phyto Pharmica Natural
Medicines
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| Vol #:
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| 111
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| LET
13432
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| PhytoPharmica Natural
Medicines
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| Vol #:
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| 111
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| LET
13433
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| PhytoPharmica Natural
Medicines
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| Vol #:
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| 111
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| LET
13434
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| Suarez Corporation Industries
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| Vol #:
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| 111
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| LET
13435
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| Naturade, Inc.
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| Vol #:
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| 111
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| LET
13436
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| Tom's of Maine
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| Vol #:
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| 111
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| LET
13437
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| Highland Laboratories
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| Vol #:
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| 111
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| LET
13438
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| Juvenon, Inc.
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| Vol #:
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| 111
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| LET
13439
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13440
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| Enzymatic Therapy Natural
Medicines
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| Vol #:
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| 111
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| LET
13441
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| Square Enterprises Corp.
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| Vol #:
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| 111
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| LET
13442
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| Nature's Way Products, Inc.
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| Vol #:
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| 111
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| LET
13443
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| Synergy Worldwide
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| Vol #:
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| 111
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| LET
13444
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| Optigenex Inc.
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| Vol #:
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| 111
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| LET
13445
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| Optigenex Inc.
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| Vol #:
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| 111
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| LET
13446
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| Optigenex Inc.
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| Vol #:
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| 111
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| LET
13447
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| Atkins Nutritionals, Inc.
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| Vol #:
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| 111
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| LET
13448
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| LET
13449
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| AdvoCare International, LP
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| Vol #:
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| 111
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| LET
13450
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| LET
13451
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| LET
13452
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| LET
13453
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| Boots Retail USa Inc.
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| Vol #:
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| 111
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| LET
13454
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| LET
13455
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| LET
13456
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| Boots Retail USA Inc.
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| Vol #:
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| 111
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| EC 1
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| Family Health International
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EC 645
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| Mrs. Karen White
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| Vol #:
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| 163
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| EC 646
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| Mr. Brett Brunkenhoefer
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| Vol #:
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| 163
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| EC 647
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| Mr. Ademar R. Rakowsky
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| Vol #:
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| 163
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| EC 648
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| Mrs. Therese More
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| Vol #:
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| 163
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| EC 649
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| Miss. H Bollman
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| Vol #:
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| 163
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| EC 650
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| Ms. Rebecca Cosby
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| Vol #:
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| 163
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| 2001P-0145
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| Change the classification of colonic irrigation systems
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| PDN
1
Attachment
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| CDRH to A. R. Hoenninger
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| Vol #:
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| 3
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| 2002D-0371
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| Human Dura Mater; Class II Special Controls Guidance
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| EC 5
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| University of Utah Neuropsychiatric Institute
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| Vol #:
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| 1
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| EC 388
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| W.J. Byrnes & Co.
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| Vol #:
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| 22
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| EC 389
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| W.J. Byrnes & Co.
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| Vol #:
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| 22
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| EC 390
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| FedEx Express
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| Vol #:
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| 22
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| EC 391
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| Federal Express Corporation
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| Vol #:
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| 2
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| 2003D-0570
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| Draft on the Clinical Evaluation of Weight-Control Drugs
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| EC 2
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| Peptimmune, Inc.
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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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| EC 11
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| Mr. Scott Kulas
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| Vol #:
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| 3
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| EC 12
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| Mrs. Rhonda Horner-Bohaty
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| Vol #:
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| 3
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| EC 13
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| none
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| Vol #:
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| 3
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| 2003N-0575
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| Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drug Information Provided to Patients
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| EC 1
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| Nat'l Council on Patient Information
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| Vol #:
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| 1
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| 2004D-0014
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| Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
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| EC 1
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| University of Arkansas for Medical Sciences
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| Vol #:
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| 1
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| EC 2
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| Mr. Don Sieg
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| Vol #:
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| 1
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| EC 3
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| Mrs. Sandra Thweatt
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| Vol #:
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| 1
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| 2004D-0117
|
| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
|
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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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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| 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
1
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| Guidance
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| Vol #:
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| 1
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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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| 2004D-0124
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| Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
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| EC 1
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| University of Arkansas for Medical Sciences
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| Vol #:
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| 1
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| 2004P-0152
|
| ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths
|
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| ACK 1
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| HFA-305 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2, 3
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| The Weinberg Group Inc.
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| Vol #:
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| 1
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| 2004P-0153
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| ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg.
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| ACK 1
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| HFA-305 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| CP
1
Attachment 1,
2, 3,
4
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| The Weinberg Group Inc.
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| Vol #:
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| 1
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