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