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| Dockets Entered
On November 14, 2005
Table of Contents
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004D-0555
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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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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| 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-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT
760
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| Statistical Report - Month of October 2005
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| Vol #:
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| 54
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| GDL
6
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| Guidance
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| Vol #:
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| 1
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| NAD
6
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| FDA
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| Vol #:
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| 1
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| 2004D-0555
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance
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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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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| BKG 1
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| Background Material
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| Vol #:
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| 2
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| NPR
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 485
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| D. Fritz
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| Vol #:
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| 165
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| C 486
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| G. Chamberlain, RD, MD, FRCS, FRCOG
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| Vol #:
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| 165
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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 53
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| J. Higgins
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| Vol #:
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| 13
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| C 54
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| S. Adams, M.D.
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| Vol #:
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| 13
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| C 55
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| C. Hug, Jr., MD, PhD
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| Vol #:
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| 13
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| C 56
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| I. Hollinger, MD
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| Vol #:
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| 13
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| C 57
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| A. Handa, MD
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| Vol #:
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| 13
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| C 58
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| B. Iannuccillo, MD
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| Vol #:
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| 13
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| C 59
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| Illegible
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| Vol #:
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| 13
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| C 60
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| D and M Ayer
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| Vol #:
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| 13
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| C 61
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| G. Vasquez
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| Vol #:
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| 13
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| C 62
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| Eligible
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| Vol #:
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| 13
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| C 63
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| M. Cohen, MD
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| Vol #:
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| 13
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| C 64
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| D. Benefiel, MD
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| Vol #:
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| 13
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| C
65
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| State of Connecticut
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| Vol #:
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| 13
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| C 66
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| E. Kent, MD
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| Vol #:
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| 13
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| C 67
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| A. Schwartz, MD
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| Vol #:
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| 13
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| C 68
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| E. Nelson, MD
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| Vol #:
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| 13
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| C 69
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| M. Napul, MD
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| Vol #:
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| 13
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| C 70
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| T. Robinson
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| Vol #:
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| 13
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| C 71
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| K. Moon, MD
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| Vol #:
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| 13
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| C 72
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| Form Letters
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| Vol #:
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| 14
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| C 73
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| W. Jordan, MD
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| Vol #:
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| 13
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| C 74
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| S. Zitello, CRNA
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| Vol #:
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| 13
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| ACK
1
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| HFA-305 to Sandoz Inc.
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| Vol #:
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| 1
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| CP
1
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| Sandoz Inc.
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| Vol #:
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| 1
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| ACK
1
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| HFA-305 to Sidley Austin Brown & Wood LLP
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| Vol #:
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| 1
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| CP
1
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| Medi-Flex, Inc.
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| Vol #:
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| 1
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