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| Dockets Entered
On November 15, 2005
Table of Contents
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| Docket #
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| Title
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| 1986V-0194
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| Rainbow Hene Serial #3050
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2002M-0118
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| Disintegrator Insulin Needle Destruction Device, P010040
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003V-0428
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| Laser Light Show
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| 2004N-0461
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| Amendment to 25.34; Categorical Exclusions Environmental Assessment
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| 2005A-0131
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| Request for an Advisory Opinion concerning a 510(k) for a medical or dental device
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| 2005M-0270
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| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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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-0424
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| Agency Information Collection Activities; Announcement of OMB Approval; Survey on Program Funding
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| 2005P-0213
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| To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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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-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| 2005P-0384
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| Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
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| 2005P-0405
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| Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2005P-0460
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| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
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| 2005P-0462
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| Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam
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| 2005P-0464
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| To move metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance
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| 1986V-0194
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| Rainbow Hene Serial #3050
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| VRA
15
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| HFZ-200 to Lasertainment Productions International
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| Vol #:
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| 1
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| EMC 2
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| Allergy & Asthma Network Mothers of Asthmatics
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| Vol #:
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| 7
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| EMC 618
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| T. Rafferty
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| Vol #:
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| 24
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| EMC 5852
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| D. Shelton
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| Vol #:
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| 789
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| EMC 5853
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| L. Lo
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| Vol #:
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| 789
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| 2002M-0118
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| Disintegrator Insulin Needle Destruction Device, P010040
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| C
1
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| Safeguard Medical Technologies, LLC
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C 57
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| R. Hunt
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| Vol #:
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| 4
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| C 58
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| B. Callahan
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| Vol #:
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| 4
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| EMC 122
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| F. Hajcak
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| Vol #:
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| 14
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1153
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| J. Wheetley
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| Vol #:
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| 11
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| EMC 1154
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| S. Ahonen
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| Vol #:
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| 11
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| EMC 1155
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| M. Oliver
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| Vol #:
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| 11
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| EMC 1156
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| M. Oliver
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| Vol #:
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| 11
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| EMC 1157
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| S. Heath
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| Vol #:
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| 11
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| 2003V-0428
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| Laser Light Show
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| VRA
2
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| HFZ-200 to Cunningham Production Resources
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| Vol #:
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| 1
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| 2004N-0461
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| Amendment to 25.34; Categorical Exclusions Environmental Assessment
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| SUP
2
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| Endotec, Incorporated
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| Vol #:
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| 2
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| 2005A-0131
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| Request for an Advisory Opinion concerning a 510(k) for a medical or dental device
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| WDL
1
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| Great Lakes Orthodontics, Ltd.
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| Vol #:
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| 1
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| C
1
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| Cook Group, Inc. (Cook)
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| Vol #:
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| 1
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| 2005D-0401
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| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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| C
2
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| Alliance Medical Corporation
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| Vol #:
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| 1
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| 2005M-0270
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| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
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| | | | | | | | |
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| C
1
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| Florida Blood Services
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| Vol #:
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| 1
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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| N
2
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| FDA
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| Vol #:
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| 1
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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 487
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| K. Raviele, M.D., F.A.C.O.G.
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| Vol #:
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| 165
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| 2005N-0424
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| Agency Information Collection Activities; Announcement of OMB Approval; Survey on Program Funding
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005P-0213
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| To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
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|
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| LET
1
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| HFZ-001 to Scientific Laboratory Products LTD
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| Vol #:
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| 1
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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| PAV
1
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| HFD-600 to The Weinberg Group Inc.
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| Vol #:
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| 1
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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
75
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| American Association of Nurse Anesthetists (AANA)
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| Vol #:
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| 20
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| C
2
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| Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2005P-0384
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| Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
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| C 1
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| C. Reeder
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| Vol #:
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| 1
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| 2005P-0405
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| Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
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| LET
1
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| Orthopedic Surgical Manufacturers Association (OSMA)
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| Vol #:
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| 4
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| |
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| C 1
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| J. Stuart
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| Vol #:
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| 1
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| ACK
1
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| HFA-305 to Kalsec Inc.
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| Vol #:
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| 1
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| CP
1
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| Kalsec Inc.
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| Vol #:
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| 1
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| 2005P-0460
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| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0462
|
| Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam
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