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| Dockets Entered On February
25, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002N-0291
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| Proposal to Debar Baldev Raj Bhutani;Notice of Opportunity
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| 2002P-0297
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| ANDA for Propoxyphene Hydrochloride, Acetaminophen&Caffeine
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| 2002P-0473
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| ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
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| 2002P-0499
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| ANDA Suitability for Metformin Hydrochloride Tablets Oral So
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| 2003N-0390
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| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| 2004M-0084
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| HDE Number: H030004; Applicant: Menssana Research Inc.; Device Tradename: Heartsbreath
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| 2004N-0046
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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| 2004P-0088
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| Petition to modify requirements for prescription/non prescription drug labeling
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| 1978N-0036L
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| OTC Laxative
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| C
214
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| Novartis Consumer Health, Inc. (NCH)
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| Vol #:
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| 134
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| SUP 16
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| Purdue Frederick Company
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| Vol #:
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| 136
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| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
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| C
22
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| Colgate-Palmolive Company
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| Vol #:
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| 86
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| C
23
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| Pfizer, Inc.
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| Vol #:
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| 86
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| C
24
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| Procter & Gamble Company
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| Vol #:
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| 86
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7386
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| J. Palmer
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| Vol #:
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| 307
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| C 7387
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| J. Bettendorf
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| Vol #:
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| 307
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
54
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| Fairhart Farm
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| Vol #:
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| 4
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| C 55
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| D. Gardner, DVM
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| Vol #:
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| 4
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| 2002N-0291
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| Proposal to Debar Baldev Raj Bhutani;Notice of Opportunity
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| SUP 3
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| B. R. Bhutani, Ph.D.
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| Vol #:
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| 1
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| 2002P-0297
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| ANDA for Propoxyphene Hydrochloride, Acetaminophen&Caffeine
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| AMD
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2002P-0473
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| ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
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| AMD
1
Attachment
1, 2,
3, 4
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| Banner Pharmacaps, Inc. (Banner)
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| Vol #:
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| 1
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| 2002P-0499
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| ANDA Suitability for Metformin Hydrochloride Tablets Oral So
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| AMD
1
Attachment
A, B
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| The Weinberg Group Inc
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| Vol #:
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| 1
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| 2003N-0390
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| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
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| C 1
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| B. Little, PhD
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| Vol #:
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| 1
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| C 76
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| Fish Mart
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| Vol #:
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| 9
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| C 77
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| R.G. Weiner
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| Vol #:
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| 9
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| C 78
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| T. Harless
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| Vol #:
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| 9
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| C 79
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| J. O'Neill
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| Vol #:
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| 9
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| C
13
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 6
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| C
14
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| Pharmavite, LLC
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| Vol #:
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| 6
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| C
15
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| Assn of Dressings & Sauces
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| Vol #:
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| 6
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| C
2
Attachment
1, 2
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| Hyman, Phelps & McNamara
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| Vol #:
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| 1
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 45
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| J. Capozzelli
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| Vol #:
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| 6
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| C 46
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| T. Solovey
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| Vol #:
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| 6
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| C 47
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| R. Lesser
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| Vol #:
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| 6
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| C
2
Attachment
1, 2
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| Hyman, Phelps & McNamara
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| Vol #:
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| 3
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 20
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| Illegible
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| Vol #:
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| 2
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| C 21
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| Gloria &Larry Filling
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| Vol #:
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| 2
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| C 22
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| B. Schut
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| Vol #:
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| 2
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| C 23
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| L. Krantz
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| Vol #:
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| 2
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| C 24
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| F. Mathews
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| Vol #:
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| 2
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| C 25
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| M. Reed
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| Vol #:
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| 2
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| C
2
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| University of Tennessee
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| Vol #:
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| 1
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| SUP
1
References
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| University of Tennessee
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| Vol #:
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| 1
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| C
2
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| American College of Physicians (ACP)
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| Vol #:
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| 1
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| 2004M-0084
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| HDE Number: H030004; Applicant: Menssana Research Inc.; Device Tradename: Heartsbreath
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| AAV
1
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| Menssana Research Inc.
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| Vol #:
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| 1
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| 2004N-0046
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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| SS 1
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| Number not used
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| Vol #:
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| 1
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| 2004P-0088
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| Petition to modify requirements for prescription/non prescription drug labeling
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| ACK 1
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| HFA-305 to Barbara Kennedy-Neslusan
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| Vol #:
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| 1
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| CP 1
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| Barbara E. Kennedy-Neslusan
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| Vol #:
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| 1
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