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| Dockets Entered
On October 28, 2005
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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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005P-0207
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| Change in Classification for Sonomet Body Composition Analyzer, BOD POD and PEAPOD
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 1978N-0036L
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| OTC Laxative
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| SUP
18
Attachments
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| Braintree Laboratories
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| Vol #:
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| 138
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18242
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| K. Pyle
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| Vol #:
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| 516
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| C 18243
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| S. Bickle
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| Vol #:
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| 516
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| C 18244
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| B. Combs
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| Vol #:
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| 516
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| C 18245
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| A. King
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| Vol #:
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| 516
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| C 18246
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| K. Sattler
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| Vol #:
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| 516
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 173
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| R. Beverly
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| Vol #:
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| 39
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| C
6
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| Johnson and Johnson Consumer and Personal Products Worldwide (CPPW)
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| 1
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| C
7
Attachments
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| Church & Dwight Co., Inc.
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| Vol #:
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| 1
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| C
3
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| Puget Sound Blood Center
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| Vol #:
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| 2
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| C
4
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 2
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| C
5
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| Michigan Community Blood Centers
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| Vol #:
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| 2
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 274
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| C. Loomis
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| Vol #:
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| 23
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| EC
1495
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| Ms. Sandra Shinazy
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| Vol #:
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| 25
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| EC
1496
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| Dr. Elizabeth Stringer
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| Vol #:
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| 25
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| EC
1497
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| Miss. Jenna Rytina
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| Vol #:
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| 25
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| EC
1498
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| Ms. Nancy Hawkins
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| Vol #:
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| 25
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| EC
1499
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| Tulare County Health and Human Services Agency
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| Vol #:
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| 25
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| EC
1500
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| Ms. Julieta Slater
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| Vol #:
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| 25
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| EC
1501
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| Ms. Theresa Shepard
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| Vol #:
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| 25
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| EC
1502
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| Ms. Sara Slaughter
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| Vol #:
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| 25
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| EC
1503
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| Ms. Gillian Patton
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| Vol #:
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| 25
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| EC
1504
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| Ms. Janet Lorraine
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| Vol #:
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| 25
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| EC
1505
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| Mr. JOSEPH LITE
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| Vol #:
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| 25
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| APE
7
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| C
1
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| The Endocrine Society
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| Vol #:
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| 1
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| 2005P-0207
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| Change in Classification for Sonomet Body Composition Analyzer, BOD POD and PEAPOD
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| LET
1
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| HFZ-001 to Life Measurement, Inc
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| Vol #:
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| 2
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| C 34
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| M. Dellinger, D.O.
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| Vol #:
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| 13
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| C 35
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| P. Mitchell, D.O.
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| Vol #:
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| 13
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| C 36
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| R. Adams, CRNA
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| Vol #:
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| 13
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| C 37
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| W. Cawthon, CRNA
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| Vol #:
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| 13
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| SUP
1
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| Cinergen
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| Vol #:
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| 2
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| CP
1
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| Banner Pharmacaps Inc. of High Point
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| Vol #:
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| 1
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