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| Dockets Entered
On January 7, 2004
Table of Contents
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| Docket #
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| Title
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1978N-0064
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| OTC Antiperspirant
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| 1990D-0194
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| RADIOIMMUNOASSAY ANALYSIS OF HAIR TO DETECT DRUG ABUSE
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| 1993P-0337
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| Amend Definition of "Biological Products"
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003D-0349
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| Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| 2003D-0465
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| 2003N-0338
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| Obesity
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003N-0456
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| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2004P-0003
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| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
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| 2004P-0004
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| Request for correction of FDA'S ''Adivce for women who are pregnant, or who might become pregnenat, and nursing mothers, about avoiding harm to your baby or young child from mercury in fish and shellf
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| 2004P-0006
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| abbreviated new drug applications ( ANDA's) for controlled-release oxycodone hydrochloride products that list OxyContin ( oxycodone HCI controlled-release )
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| 2004P-0008
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| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
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| 2004V-0005
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| Laser Light Show
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| 2004V-0007
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| Laser Light Show
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| C
89
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| Woodward Laboratories, Inc.
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| Vol #:
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| 200
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| CR
1
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| Colgate-Palmolive Company
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| Vol #:
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| 200
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| 1978N-0064
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| OTC Antiperspirant
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| SUP
4
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| Revlon, Inc.
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| Vol #:
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| 51
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| 1990D-0194
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| RADIOIMMUNOASSAY ANALYSIS OF HAIR TO DETECT DRUG ABUSE
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| BKG 2
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| Background Material
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| Vol #:
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| 1
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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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| 1993P-0337
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| Amend Definition of "Biological Products"
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| PDN
1
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| HFC-1 to Animal Health Institute
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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
12151
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12152
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12153
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12154
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12155
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| Schiff Breast Health Formula
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| Vol #:
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| 97
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| LET
12156
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12157
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12158
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12159
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12160
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12161
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12162
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12163
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12164
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12165
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12166
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12167
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12168
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| Natreon, Inc.
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| Vol #:
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| 97
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| LET
12169
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| Rexall Sundown
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| Vol #:
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| 97
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| LET
12170
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| Rexall , Inc.
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| Vol #:
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| 97
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| LET
12171
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| Rexall Inc.
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| Vol #:
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| 97
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| LET
12172
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| Rexall Inc.
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| Vol #:
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| 97
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| LET
12173
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12174
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| Nutritional Specialties, inc.
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| Vol #:
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| 97
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| LET
12175
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12176
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12177
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12178
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12179
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12180
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| Nutritional Specialties, Inc.
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| Vol #:
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| 97
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| LET
12181
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| Leiner Health Products
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| Vol #:
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| 97
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| LET
12182
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| Leiner Health Products
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| Vol #:
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| 97
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| LET
12183
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| Leiner Health Products
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| Vol #:
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| 97
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| LET
12184
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| Leiner Health Products
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| Vol #:
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| 97
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| LET
12185
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| Leiner Health Products
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| Vol #:
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| 97
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| 2003D-0349
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| Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
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| EMC
4
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| EMC
2
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| Datex-Ohmeda, Inc.
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| Vol #:
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| 1
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| EMC
3
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| Bio-Rad Laboratories
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| Vol #:
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| 1
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| 2003D-0465
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
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| EMC
2
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EMC
16
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| King Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| EMC
17
Attachment
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| Galderma Laboratories, LP (Galderma)
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| Vol #:
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| 2
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| EMC
18
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| International Guai-Support Group Network
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| Vol #:
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| 2
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| EMC
19
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| Kleinfeld,Kaplan & Becker, LLP
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| Vol #:
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| 2
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| EMC
20
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| Adams Laboratories, Inc.
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| Vol #:
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| 2
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| EMC 21
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| C. Peters, PhD
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| Vol #:
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| 2
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| EMC 22
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| Number Not Used
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| Vol #:
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| 2
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| EMC 23
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| Number Not Used
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| Vol #:
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| 2
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| EMC 24
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| W. Arrigoni
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| Vol #:
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| 2
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| EMC 25
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| D.A. Brown
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| Vol #:
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| 2
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| EMC 26
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| N. Kilkeary
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| Vol #:
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| 2
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| EMC 27
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| J. Terry
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| Vol #:
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| 2
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| EMC 28
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| P. Cockle
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| Vol #:
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| 2
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| EMC 29
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| P. Dietel
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| Vol #:
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| 2
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| EMC 30
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| T. J. Rowan
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| Vol #:
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| 2
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| EMC 31
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| No signature
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| Vol #:
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| 2
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| EMC 32
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| S. Brady
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| Vol #:
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| 2
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| EMC 1
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| R.A. Horvitz, MD
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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 42
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| C.L. Baldwin
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| Vol #:
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| 10
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| EMC
43
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| Westin A. Price Foundation
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| Vol #:
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| 10
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| EMC 44
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| R.A. Daynard,JD,PhD
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| Vol #:
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| 10
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| EMC
45
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| Staff of the Bureau of Consumer Protection, Economics and the Office of Policy Planning of the FTC
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| Vol #:
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| 10
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| EMC
46
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| International Dairy Foods Assn (IDFA)
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| Vol #:
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| 10
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| EMC 47
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| j. Epstein
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| Vol #:
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| 10
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| EMC
42
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| Johnson & Johnson Pharmaceutical Research & Development, LLC
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| Vol #:
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| 7
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| 2003N-0456
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| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
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| EMC
1
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| Compressed Gas Assn (CGA)
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| Vol #:
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| 1
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| EMC
2
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| Gas Regs, Inc.
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| Vol #:
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| 1
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| EMC
1
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| Zymed Laboratories
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| Vol #:
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| 1
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| EMC 83
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| J. Wood
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| Vol #:
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| 2
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 13
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| Dr. R.D. Wright
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| Vol #:
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| 1
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| EMC 14
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| D.A. Berkey, AuD
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| Vol #:
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| 1
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| EMC 15
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| E.H. Berger
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| Vol #:
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| 1
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| EMC 16
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| R.J. Olsson, AuD
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| Vol #:
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| 1
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| EMC 1
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| Dr. R.D. Wright
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| Vol #:
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| 1
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| EMC 2
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| D.A. Berkey, AuD
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| Vol #:
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| 1
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| EMC 3
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| R.J. Olsson, AuD
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| Vol #:
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| 1
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| 2004P-0003
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| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
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| ACK 1
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| HFA-305 to Billy G. Pierson
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| Vol #:
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| 1
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| PRC 1
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| Billy G. Pierson
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| Vol #:
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| 1
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|
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| 2004P-0004
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| Request for correction of FDA'S ''Adivce for women who are pregnant, or who might become pregnenat, and nursing mothers, about avoiding harm to your baby or young child from mercury in fish and shellf
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|
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| ACK 1
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| HFA-305 to Environmental Working Group
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| Vol #:
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| 1
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| CP
1
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| Environmental Working Group
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| Vol #:
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| 1
|
| |
|
|
| 2004P-0006
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| abbreviated new drug applications ( ANDA's) for controlled-release oxycodone hydrochloride products that list OxyContin ( oxycodone HCI controlled-release )
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| |
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| ACK 1
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| HFA-305 to Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 1
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| |
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| PSA
1
Tab A
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| Kleinfeld, Kaplan and Becker, LLP
|
| Vol #:
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| 1
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| |
|
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| 2004P-0008
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| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
|
| |
|
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| ACK
1
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| HFA-305 to Cancer Action NY
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| Vol #:
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| 1
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| |
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| CP
1
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| Cancer Action NY
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| Vol #:
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| 1
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| | | | | | | | |
| |
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| 2004V-0005
|
| Laser Light Show
|
| |
|
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| ACK 1
|
| HFA-305 to King Lasers
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| Vol #:
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| 1
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| |
|
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| VAR
1
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| King Lasers
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| Vol #:
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| 1
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| |
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| 2004V-0007
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| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to East Kentucky Science Center
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
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| East Kentucky Science Center
|
| Vol #:
|
| 1
|
|
Page created January 8, 2004 jb
Page updated January 27, 2004
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