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| Dockets Entered
On June 3, 2004
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1978N-0064
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| OTC Antiperspirant
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| 1980P-0100
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| LIGHT SHOW PROJECTOR "RAINBOW"
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| 1981N-0050
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| OTC for treatment of acute toxic ingestion human use
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| 1984N-0102
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| Orphan Product Designations
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| 1986V-0476
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| Laser light show
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| 1988V-0116
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| VARIANCE RE LASER LIGHT SHOW
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| 1989V-0513
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| Laser Light Show for E.T.I. Beam Master Model Two
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| 1993V-0079
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| Laser Light Show
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1995V-0043
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| Variance for the Scanning Beam Digital X-ray System
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| 1996V-0474
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| Variance Application for High Pressure Mercury Vapor Lamps
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998N-0044
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| Effect of dietary supplement on structure/function of body
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999D-0529
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| Draft Guidance for Ind - Changes to an Approved NDA or ANDA
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000P-1406
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| Stay Presenting, publishing promulgating "Fresh Air" Speeche
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| 2000V-1287
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| Laser Light Show
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0471
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| Issue the NFR Placement of Anthrax Vaccine as Category II
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| 2002D-0350
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| Handling and Retention of Bioavailability and Bioequivalence
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| 2002E-0149
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| Genesis Neurostimulation System, U.S. Patent No. 4,793,353
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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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| 2002P-0377
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| Petition Requesting Stay of Approval of Mifeprex
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| 2002V-0158
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| Laser Light Show
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0404
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
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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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| 2004N-0046
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| | | | | | | | |
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| MM
26
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| Minutes of Meeting Held on 04/30/2004 between FDA and BayerHealthCare
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| Vol #:
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| 235
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|
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| 1978N-0064
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| OTC Antiperspirant
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|
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| SUP
6
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| Revlon, Inc.
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| Vol #:
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| 53
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| 1980P-0100
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| LIGHT SHOW PROJECTOR "RAINBOW"
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|
| VRA
13
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| HFZ-300 to Greenco, LLC dba LFI International
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| Vol #:
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| 1
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| SUP
7
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 16
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| 1981N-0050
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| OTC for treatment of acute toxic ingestion human use
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| SUP
2
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| American Assn of Poison Control Centers
|
| Vol #:
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| 2
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| 1984N-0102
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| Orphan Product Designations
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| LST
101
Part 2, part
3
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| List of Orphan Drug
|
| Vol #:
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| 6
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|
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| 1986V-0476
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| Laser light show
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|
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| VRA
10
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| HFZ-300 to Stone Mountain Productions/Lasers, Inc.
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| Vol #:
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| 1
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| 1988V-0116
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| VARIANCE RE LASER LIGHT SHOW
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|
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| VRA
8
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| HFZ-300 to LaserMation, LLC
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| Vol #:
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| 1
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| 1989V-0513
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| Laser Light Show for E.T.I. Beam Master Model Two
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| VRA
4
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| HFZ-300 to Music Unlimited
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| Vol #:
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| 1
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| 1993V-0079
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| Laser Light Show
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|
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|
| VRA
5
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| HFZ-300 to Shoji Entertainment Inc.
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| Vol #:
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| 1
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|
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|
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
|
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| C
4053
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| Herbal Health, Inc.
|
| Vol #:
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| 398
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|
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| C
4054
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| Nutritional Supplements Corp.
|
| Vol #:
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| 398
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| 1995V-0043
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| Variance for the Scanning Beam Digital X-ray System
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|
|
|
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| VRA
2
|
| HFZ-300 to NexRay, Inc.
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| Vol #:
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| 1
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|
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| 1996V-0474
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| Variance Application for High Pressure Mercury Vapor Lamps
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| EXP
1
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| General Electric Company
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| Vol #:
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| 1
|
|
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|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
|
|
|
| LET
14059
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| Enzymatic Therapy
|
| Vol #:
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| 121
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|
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| LET
14060
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| Instone, LLC
|
| Vol #:
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| 121
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| | | | | | | | |
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| LET
14061
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| Instone, LLC
|
| Vol #:
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| 121
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| LET
14062
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| Instone, LLC
|
| Vol #:
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| 121
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| LET
14063
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| Instone, LLC
|
| Vol #:
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| 121
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|
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| LET
14064
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| Enzymatic Therapy
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| Vol #:
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| 121
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|
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|
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| LET
14065
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| Enzymatic Therapy
|
| Vol #:
|
| 121
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|
|
|
|
| LET
14066
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
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|
|
|
|
| LET
14067
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14068
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
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|
|
|
|
| LET
14069
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14070
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14071
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 121
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|
|
|
|
| LET
14072
|
| Nature-Recommended, LLC
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14073
|
| Nature-Recommended, LLC
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14074
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
|
|
|
|
|
| LET 14075
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| Ryan Parsons
|
| Vol #:
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| 121
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|
|
|
|
| LET
14076
|
| Enzymatic Therapy
|
| Vol #:
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| 121
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|
|
|
|
| LET
14077
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14078
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14079
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14080
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14081
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14082
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14083
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14084
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14085
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14086
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14087
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14088
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
|
|
|
|
|
| LET
14089
|
| Enzymatic Therapy
|
| Vol #:
|
| 121
|
|
|
|
|
| 1998N-0044
|
| Effect of dietary supplement on structure/function of body
|
|
|
|
|
| C 22419
|
| M. Slowey
|
| Vol #:
|
| 883
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7434
|
| S. Sheikh
|
| Vol #:
|
| 307
|
|
|
|
|
| C 7435
|
| M. Chen
|
| Vol #:
|
| 307
|
|
|
|
|
| 1999D-0529
|
| Draft Guidance for Ind - Changes to an Approved NDA or ANDA
|
|
| | | | | | | | |
|
|
|
|
| REF
1
Tab A, continued,
Tab B
|
| HF-26
|
| Vol #:
|
| 6
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EMC 780
|
| Jane Pittari
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 781
|
| Rachelle Giuliani
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 782
|
| Sandee Sousa
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 783
|
| K. R. Pence
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 784
|
| M Contreras-Gernentz
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 785
|
| Paulette Plaskon
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 786
|
| David DeMarais
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 787
|
| Coris Ford
|
| Vol #:
|
| 271
|
|
|
|
|
| 2000P-1406
|
| Stay Presenting, publishing promulgating "Fresh Air" Speeche
|
|
|
|
|
| PAV
1
|
| HFC-1 to Arent Fox Kintner Plotkin & Kahn
|
| Vol #:
|
| 1
|
|
|
|
|
| 2000V-1287
|
| Laser Light Show
|
|
|
|
|
| VRA
3
|
| HFZ-300 to Main Light Industries, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| ACK
2
|
| HFA-305 to Pharmacists Planning Service, Inc (PPSI)
|
| Vol #:
|
| 236
|
|
|
|
|
| 2001P-0471
|
| Issue the NFR Placement of Anthrax Vaccine as Category II
|
|
|
|
|
| SUP
1
Continued
|
| HFM-17
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002D-0350
|
| Handling and Retention of Bioavailability and Bioequivalence
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002E-0149
|
| Genesis Neurostimulation System, U.S. Patent No. 4,793,353
|
|
|
|
|
| LET
4
|
| HFD-005 to Hughes & Luce, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| C
240
|
| Customs Brokers and Foreign Freight Forwarders Assn of Chicago (CBFFFAC)
|
| Vol #:
|
| 27
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C
335
|
| ANA Trading Corp, USA
|
| Vol #:
|
| 25
|
|
|
|
|
| C
336
|
| Deutsche Pst AG
|
| Vol #:
|
| 25
|
|
|
|
|
| C
337
|
| Chilean Exporters Assn (ASOEX)
|
| Vol #:
|
| 25
|
|
|
|
|
| C
338
|
| Customs Brokers and Foreign Freight Forwarders Assn of Chicago (CBFFFAC)
|
| Vol #:
|
| 25
|
|
|
|
|
| 2002P-0377
|
| Petition Requesting Stay of Approval of Mifeprex
|
|
| | | | | | | | |
|
|
|
|
| C
4
Table of Contents
References
|
| National Abortion Federation (NAF) and Planned Parenthood Federation of America (PPFA)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2002V-0158
|
| Laser Light Show
|
|
|
|
|
| VRA
2
|
| HFZ-300 to Sorcar Engineering, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| LST
3
|
| GCF-1
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0404
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0575
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drug Information Provided to Patients
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0046
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| EC
55
|
| Biotechnology Industry Organization
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
56
|
| Biotechnology Industry Organization
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
57
|
| United Seniors Association
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
58
|
| Indiana University Dept of Anesthesia/ Pain
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
59
|
| California Association of Black Lawyers
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
60
|
| Massachusetts Soc. of Health-System Pharmacists
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
61
|
| Ms. DeArra Foster
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
62
|
| Iowa Healthcare Access Network
|
| Vol #:
|
| 14
|
|
|
|
|
| EC
63
|
| NAMImass
|
| Vol #:
|
| 14
|
|
|
|
|
| TS
81
|
| The Ontario College of Pharmacists
|
| Vol #:
|
| 14
|
|
|
|
|
| TS
82
|
| Pharmacists Services and the Internet Pharmacy
|
| Vol #:
|
| 14
|
|
|
|
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
