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| Dockets Entered
On October 4, 2005
Table of Contents
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| Docket #
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| Title
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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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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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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| 2004P-0452
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| Regulate the use of coding on food labels
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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-0342
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems: Availability
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| 2005N-0290
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005N-0341
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| Medical Devices; Immunology and Microbiology Devices; Classification of AFP-L3% Immunological Test Systems
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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-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| 2005P-0115
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| Immediately remove from the market pemoline CYLER- Abbott Laboratories, and all generic versions, a stimulant drug for the treatment of attention deficit hyperactivity disorder.
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| 2005P-0134
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| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
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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-0407
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| ANDA for Efavirenz Tablets for Oral Suspension 50 mg, 100 mg and 200 mg
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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16578
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 149
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| LET
16579
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 149
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| LET
16580
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| Anabolic Laboratories, Inc.
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| Vol #:
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| 149
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| LET
16581
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16582
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16583
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| Enzymatic Therapy
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| Vol #:
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| 149
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| LET
16584
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| Hillestad Pharmaceuticals
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| Vol #:
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| 149
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| LET
16585
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16586
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16587
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16588
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16589
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16590
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16591
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16592
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| Apex Fitness Group
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| Vol #:
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| 149
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18239
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| H. Vasselin
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| Vol #:
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| 516
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| C 18240
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| T. Chapman
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| Vol #:
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| 516
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1362
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| H. Vasselin
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| Vol #:
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| 259
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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 45
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| H. Vasselin
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| Vol #:
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| 5
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| 2004P-0452
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| Regulate the use of coding on food labels
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| PDN
1
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| HFC-1 to Bunny Abraham
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| Vol #:
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| 1
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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 2
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| I. Magnusson, DDS, Odont.Dr.
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| Vol #:
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| 1
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| 2005D-0342
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems: Availability
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0290
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| EC
1
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| Canadian Embassy, Washington
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| Vol #:
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| 1
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| 2005N-0341
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| Medical Devices; Immunology and Microbiology Devices; Classification of AFP-L3% Immunological Test Systems
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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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| 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 40
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| S. Collins
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| Vol #:
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| 9
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| C 41
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| J. Newman
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| Vol #:
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| 9
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| C 42
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| G. Griffin
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| Vol #:
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| 9
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| C 43
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| P. Pitts
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| Vol #:
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| 9
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| C 44
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| L. Mouhalis
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| Vol #:
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| 9
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| C 45
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| S. Workman/H. Johnson
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| Vol #:
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| 9
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| C 46
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| M. Cole
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| Vol #:
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| 9
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| C 47
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| M. McGuire
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| Vol #:
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| 9
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| C 48
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| W. Hager, M.D.
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| Vol #:
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| 9
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| EC 554
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| Mr. Joe Bessler
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| Vol #:
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| 6
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| EC 555
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| Pharmacist
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| Vol #:
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| 6
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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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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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| NM
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0115
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| Immediately remove from the market pemoline CYLER- Abbott Laboratories, and all generic versions, a stimulant drug for the treatment of attention deficit hyperactivity disorder.
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| LET
1
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| HFD-005 to Public Citizen
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| Vol #:
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| 1
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| 2005P-0134
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| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
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| LET
1
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| HFD-005 to ISTA Pharmaceuticals
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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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| EC
99
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| American Society of Anesthesiologists
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| Vol #:
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| 2
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| 2005P-0407
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| ANDA for Efavirenz Tablets for Oral Suspension 50 mg, 100 mg and 200 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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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| EC 4
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| Dr. Michael Hart
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| Vol #:
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| 6
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| EC
5
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| Stanford University Medical Center
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| Vol #:
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| 6
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