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| Dockets Entered
On October 18, 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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| 2001D-0584
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| Reduce the Risk of Transmission of HIV-1 & HCV
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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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-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005P-0273
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| Add Calcium to the Mandatory List
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| 2005P-0360
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| salmon calcitonin products unless certain conditions are met FDA should not approved
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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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-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| 2005V-0108
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16645
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16646
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16647
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16648
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16649
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16650
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16651
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16652
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16653
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| NBTY Inc.
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| Vol #:
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| 149
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| LET
16654
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| NBTY Inc.
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| Vol #:
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| 149
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| 2001D-0584
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| Reduce the Risk of Transmission of HIV-1 & HCV
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| EC 4
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| Ms. Colleen O'Neill
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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
56
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| South Dakota Department of Agriculture
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| Vol #:
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| 4
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| EMC 45
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| Form Letter count
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| Vol #:
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| 15
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| LET
11
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| American Longevity (AL)
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| Vol #:
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| 16
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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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| BKG 1
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| Background Material
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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 87
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| M. Campirano
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| Vol #:
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| 9
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| C
88
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| Colorado Organization for Latina Opportunity and reproductive Rights (COLOR)
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| Vol #:
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| 9
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| C 89
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| M. Olsen
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| Vol #:
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| 9
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| C
90
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| National LAtina Institute for Reproductive Health (NLIRH)
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| Vol #:
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| 9
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| C 91
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| J. McCullough
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| Vol #:
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| 9
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| C 92
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| C. Regnery
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| Vol #:
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| 9
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| C 93
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| M. Duggan
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| Vol #:
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| 9
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| C 94
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| H. Warvolis
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| Vol #:
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| 9
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| C 95
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| C. Madden
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| Vol #:
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| 9
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| C 96
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| W. Murphy
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| Vol #:
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| 9
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| C 97
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| G. Gilson, MD
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| Vol #:
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| 9
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| C 98
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| M. Collins
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| Vol #:
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| 9
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| C 99
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| D. Leafey
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| Vol #:
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| 9
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| C 100
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| C. Litzelman
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| Vol #:
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| 9
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| C 101
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| Form Letters
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| Vol #:
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| 12
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| C 102
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| C. Diak, MD
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| Vol #:
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| 9
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| C
103
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| Southwestern Medical Clinic, P.C.
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| Vol #:
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| 9
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| C
104
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| Planned Parenthood of Metropolitan New Jersey, Inc.
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| Vol #:
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| 9
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| C 105
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| Form Letter count 28
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| Vol #:
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| 13
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| EC
903
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| Mrs. Margaret Kopp
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| Vol #:
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| 6
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| EC
904
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| Mrs. Micki Allen
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| Vol #:
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| 6
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| EC
905
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| Reproductive Endocriniologists
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| Vol #:
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| 6
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| EC
906
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| Mr. Charles Irvin
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| Vol #:
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| 6
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| EC
907
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| Mr. David Sadowski
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| Vol #:
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| 6
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| EC
908
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| Mrs. Heather Thomas
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| Vol #:
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| 6
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| EC
909
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| Mrs. Judith Bayba
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| Vol #:
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| 6
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| EC
910
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| Mr. Stephen Routhe
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| Vol #:
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| 6
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| EC
911
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| Dr. Russell Sura
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| Vol #:
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| 6
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| EC
912
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| Mr. William Moses
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| Vol #:
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| 6
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| EC
913
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| Mr. Robert Lacey
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| Vol #:
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| 6
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| EC
914
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| Dr. Kathryn Johnson
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| Vol #:
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| 6
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| EC
915
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| Mrs. Melissa Benton
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| Vol #:
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| 6
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| CR
1
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| Gallup & Robinson Inc
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| Vol #:
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| 2
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| EAPE 25
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| Liversidge, Ellen
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| Vol #:
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| 1
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| EAPE 26
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| Wilder, Marcy
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| Vol #:
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| 1
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| EAPE 27
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| Siaton, Gerry
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| Vol #:
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| 1
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): 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-0273
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| Add Calcium to the Mandatory List
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| C 2
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| L. Raisz, M.D.
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| Vol #:
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| 2
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| C 1
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| Dr. M. Williams, M.D.
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| Vol #:
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| 1
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| 2005P-0360
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| salmon calcitonin products unless certain conditions are met FDA should not approved
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| C
2
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| Nastech Pharmaceutical Company, Inc. (Nastech)
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| Vol #:
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| 1
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| C
1
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| Hyman, Phelps & McNamara, P.C.
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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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| AMD
1
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| Orthopedic Surgical Manufacturers Association (OSMA)
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| Vol #:
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| 3
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| 2005P-0417
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| ANDA for Tretinoin Cream Drug Products in Strengths of 0.0375% and 0.075%
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| ACK
1
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| HFA-305 to Triax Pharmaceuticals, LLC
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| Vol #:
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| 1
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| CP
1
References
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| Triax Pharmaceuticals, LLC
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| Vol #:
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| 1
|
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| 2005P-0418
|
| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| |
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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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| 2005V-0108
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| Laser Light Show
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| VRA
1
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| HFZ-200 to Lorenzo Entertainment II, Inc. dba Posh Niteclub
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| Vol #:
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| 1
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