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| Dockets Entered
On March 22, 2006
Table of Contents
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| Docket #
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| Title
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|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
|
| 2005P-0402
|
| Amend or
permit amendment of the labeling of all lithium-containing drugs to
include the additional indication "to reduce the incidence of
suicide and suicide attempts in manic-depressive illness."
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions
to Counter Flagrant Violations of the Law by Pharmacies Compounding
Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
|
|
|
| LET 17343
|
| Sante Active, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17344
|
| Vergance
|
| Vol #:
|
| 159
|
|
|
| LET 17345
|
| Lapte Enterprises,
Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17346
|
| PatentHealth,LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17347
|
| AdvoCare International,
L.P.
|
| Vol #:
|
| 159
|
|
|
| LET 17348
|
| AdvoCare International,
L.P.
|
| Vol #:
|
| 159
|
|
|
| LET 17349
|
| PatentHealth, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17350
|
| PatentHealth, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17351
|
| PatentHealth, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17352
|
| Arkopharma, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17353
|
| Arkopharma, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17354
|
| Arkopharma, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17355
|
| Arkopharma, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17356
|
| Arkopharma, LLC
|
| Vol #:
|
| 159
|
|
|
| LET 17357
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17358
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17359
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17360
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17361
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17362
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17363
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17364
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17365
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17366
|
| Newmark:A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17367
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17368
|
| Newmark: A Division
of New Chapter, Inc.
|
| Vol #:
|
| 159
|
|
|
| LET 17369
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 159
|
|
|
| LET 17370
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 159
|
|
|
| LET 17371
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 159
|
|
|
| LET 17372
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 159
|
|
| | | | | | | | |
|
|
| 2005P-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
|
|
|
|
|
|
| CR 1
|
| Ross J. Baldessarini, M.D. & Frederick K. Goodwin, M.D.
|
| Vol #:
|
| 5
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 3675
|
| L. Ross
|
| Vol #:
|
| 64
|
|
|
| C 3676
|
| A. Baca
|
| Vol #:
|
| 64
|
|
|
| C 3677
|
| C. Jordan
|
| Vol #:
|
| 64
|
|
|
| C 3678
|
| A. Heller
|
| Vol #:
|
| 64
|
|
|
| C 3679
|
| J. Gale
|
| Vol #:
|
| 64
|
|
|
| C 3680
|
| S. Hancock
|
| Vol #:
|
| 64
|
|
|
| C 3681
|
| B. Kreusch
|
| Vol #:
|
| 64
|
|
|
| C 3682
|
| F. Fairchild
|
| Vol #:
|
| 64
|
|
|
| C 3683
|
| N. Ullom
|
| Vol #:
|
| 64
|
|
|
| C 3684
|
| B. Hunt
|
| Vol #:
|
| 64
|
|
|
| C 3685
|
| A. Dharte
|
| Vol #:
|
| 64
|
|
|
| C 3686
|
| J. Morgan
|
| Vol #:
|
| 64
|
|
|
| C 3687
|
| C. Peyser
|
| Vol #:
|
| 64
|
|
|
| C 3688
|
| R. Brune
|
| Vol #:
|
| 64
|
|
|
| C 3689
|
| C. Olson
|
| Vol #:
|
| 64
|
|
|
| C 3690
|
| B. Nyenhuis
|
| Vol #:
|
| 64
|
|
|
| C 3691
|
| C. Bennett
|
| Vol #:
|
| 64
|
|
|
| C 3692
|
| J. Valdez
|
| Vol #:
|
| 64
|
|
|
| C 3693
|
| R. McLeon
|
| Vol #:
|
| 64
|
|
|
| C 3694
|
| J. Donner
|
| Vol #:
|
| 64
|
|
|
| C 3695
|
| K. Noyes
|
| Vol #:
|
| 64
|
|
|
| C 3696
|
| C. Davenport
|
| Vol #:
|
| 64
|
|
|
| C 3697
|
| A. Elias
|
| Vol #:
|
| 64
|
|
|
| C 3698
|
| C. Cardarehi
|
| Vol #:
|
| 64
|
|
|
| C 3699
|
| A. Waller
|
| Vol #:
|
| 64
|
|
|
| C 3700
|
| T. Weber
|
| Vol #:
|
| 64
|
|
|
| C 3701
|
| C. Lester
|
| Vol #:
|
| 64
|
|
|
| C 3702
|
| E. Bradley
|
| Vol #:
|
| 64
|
|
|
| C 3703
|
| L. Vester
|
| Vol #:
|
| 64
|
|
|
| C 3704
|
| J. Larson
|
| Vol #:
|
| 64
|
|
|
| C 3705
|
| B. Menendez
|
| Vol #:
|
| 64
|
|
|
| C 3706
|
| D. Wright
|
| Vol #:
|
| 64
|
|
| | | | | | | |
|
|
| C 3707
|
| V. Robects
|
| Vol #:
|
| 64
|
|
|
| C 3708
|
| E. Biggs
|
| Vol #:
|
| 64
|
|
|
| C 3709
|
| I. Serbin, M.D.
|
| Vol #:
|
| 64
|
|
|
| C 3710
|
| K. Westerman
|
| Vol #:
|
| 64
|
|
|
| C 3711
|
| J. Rutledge
|
| Vol #:
|
| 64
|
|
|
| C 3712
|
| K. Bartholomew
|
| Vol #:
|
| 64
|
|
|
| C 3713
|
| S. Rose
|
| Vol #:
|
| 64
|
|
|
| C 3714
|
| C. Flaherty
|
| Vol #:
|
| 64
|
|
|
| C 3715
|
| C. Flaherty
|
| Vol #:
|
| 64
|
|
|
| C 3716
|
| E. Baker, MD
|
| Vol #:
|
| 64
|
|
|
| C 3717
|
| J. Richey
|
| Vol #:
|
| 64
|
|
|
| C 3718
|
| S. Armstrong
|
| Vol #:
|
| 64
|
|
|
| C 3719
|
| E. Perez
|
| Vol #:
|
| 64
|
|
|
| C 3720
|
| A. Burns
|
| Vol #:
|
| 64
|
|
|
| C 3721
|
| B. Russell
|
| Vol #:
|
| 64
|
|
|
| C 3722
|
| J. Rummage
|
| Vol #:
|
| 64
|
|
|
| C 3723
|
| P. Haynes, MD
|
| Vol #:
|
| 64
|
|
|
| C 3724
|
| P. Haynes, MD
|
| Vol #:
|
| 64
|
|
|
| C 3725
|
| A. Ryan, MD
|
| Vol #:
|
| 64
|
|
|
| C 3726
|
| T. Whorton
|
| Vol #:
|
| 64
|
|
|
| C 3727
|
| Eligible
|
| Vol #:
|
| 64
|
|
|
| C 3728
|
| I. Noble
|
| Vol #:
|
| 64
|
|
|
| C 3729
|
| R. Vaughan
|
| Vol #:
|
| 64
|
|
|
| C 3730
|
| T. McGregor
|
| Vol #:
|
| 64
|
|
|
| C 3731
|
| A. Barrett
|
| Vol #:
|
| 64
|
|
|
| C 3732
|
| L. Shelley
|
| Vol #:
|
| 64
|
|
|
| C 3733
|
| D. Harris
|
| Vol #:
|
| 64
|
|
|
| C 3734
|
| A. Johnson
|
| Vol #:
|
| 64
|
|
|
| C 3735
|
| J. Deardorff
|
| Vol #:
|
| 64
|
|
|
| C 3736
|
| R. Burgess
|
| Vol #:
|
| 64
|
|
|
| C 3737
|
| C. Alongi
|
| Vol #:
|
| 64
|
|
|
| C 3738
|
| T. Simonsen
|
| Vol #:
|
| 64
|
|
|
| C 3739
|
| C. Richardson
|
| Vol #:
|
| 64
|
|
|
| C 3740
|
| V. Kennon
|
| Vol #:
|
| 64
|
|
|
| C 3741
|
| A. Broding
|
| Vol #:
|
| 64
|
|
|
| C 3742
|
| J. Mouser
|
| Vol #:
|
| 64
|
|
|
| C 3743
|
| D. Groarke
|
| Vol #:
|
| 64
|
|
| | | | | | | |
|
|
| C 3744
|
| V. Kenedy
|
| Vol #:
|
| 64
|
|
|
| C 3745
|
| J. Zordich
|
| Vol #:
|
| 64
|
|
|
| C 3746
|
| C. Kraich
|
| Vol #:
|
| 64
|
|
|
| C 3747
|
| C. Rodriguez
|
| Vol #:
|
| 64
|
|
|
| C 3748
|
| S. Sinclaire
|
| Vol #:
|
| 64
|
|
|
| C 3749
|
| P. Hamlin
|
| Vol #:
|
| 64
|
|
|
| C 3750
|
| C. Rickey
|
| Vol #:
|
| 64
|
|
|
| C 3751
|
| E. Robbins, MD
|
| Vol #:
|
| 64
|
|
|
| C 3752
|
| E. Smith
|
| Vol #:
|
| 64
|
|
|
| C 3753
|
| A. Bense
|
| Vol #:
|
| 64
|
|
|
| C 3754
|
| D. Lovell
|
| Vol #:
|
| 64
|
|
|
| C 3755
|
| J. Hauck
|
| Vol #:
|
| 64
|
|
|
| C 3756
|
| G. Terrell
|
| Vol #:
|
| 64
|
|
|
| C 3757
|
| P. Heart
|
| Vol #:
|
| 64
|
|
|
| C 3758
|
| L. Ostroff
|
| Vol #:
|
| 64
|
|
|
| C 3759
|
| C. Lippard
|
| Vol #:
|
| 64
|
|
|
| C 3760
|
| C. Peterson
|
| Vol #:
|
| 64
|
|
|
| C 3761
|
| C. Rodriguez
|
| Vol #:
|
| 64
|
|
|
| C 3762
|
| L. Sparks
|
| Vol #:
|
| 64
|
|
|
| C 3763
|
| M. Remhoff
|
| Vol #:
|
| 64
|
|
|
| C 3764
|
| K. Ajello
|
| Vol #:
|
| 64
|
|
|
| C 3765
|
| J. Cline
|
| Vol #:
|
| 64
|
|
|
| C 3766
|
| J. Dauphine
|
| Vol #:
|
| 64
|
|
|
| C 3767
|
| A. Wilson
|
| Vol #:
|
| 64
|
|
|
| C 3768
|
| S. Presley
|
| Vol #:
|
| 64
|
|
|
| C 3769
|
| H. Farrel
|
| Vol #:
|
| 64
|
|
|
| C 3770
|
| N. Pryor
|
| Vol #:
|
| 64
|
|
|
| C 3771
|
| M. Koneeit
|
| Vol #:
|
| 64
|
|
|
| C 3772
|
| W. Combes
|
| Vol #:
|
| 64
|
|
|
| C 3773
|
| R. Freedenfeld
|
| Vol #:
|
| 64
|
|
|
| C 3774
|
| D. BEaver
|
| Vol #:
|
| 64
|
|
|
| C 3775
|
| C. Schenik
|
| Vol #:
|
| 64
|
|
|
| C 3776
|
| N. Colyer
|
| Vol #:
|
| 64
|
|
|
| C 3777
|
| M. Moffatt
|
| Vol #:
|
| 64
|
|
|
| C 3778
|
| G. Moore
|
| Vol #:
|
| 64
|
|
|
| C 3779
|
| J. McReynolds
|
| Vol #:
|
| 64
|
|
|
| C 3780
|
| L. Timpode
|
| Vol #:
|
| 64
|
|
| | | | | | | |
|
|
| C 3781
|
| L. Gottlieb
|
| Vol #:
|
| 64
|
|
|
| C 3782
|
| N. Blau, RN
|
| Vol #:
|
| 64
|
|
|
| C 3783
|
| T. Amaher
|
| Vol #:
|
| 64
|
|
|
| C 3784
|
| L. Ganga
|
| Vol #:
|
| 64
|
|
|
| C 3785
|
| M. Diaz
|
| Vol #:
|
| 64
|
|
|
| C 3786
|
| R. Steeler
|
| Vol #:
|
| 64
|
|
|
| C 3787
|
| A. Nichols
|
| Vol #:
|
| 64
|
|
|
| C 3788
|
| R. Schmidt
|
| Vol #:
|
| 64
|
|
|
| C 3789
|
| J. Kleinman
|
| Vol #:
|
| 64
|
|
|
| C 3790
|
| M. Williams
|
| Vol #:
|
| 64
|
|
|
| C 3791
|
| L. Dribin
|
| Vol #:
|
| 64
|
|
|
| C 3792
|
| J. Stokes
|
| Vol #:
|
| 64
|
|
|
| C 3793
|
| K. Chavez
|
| Vol #:
|
| 64
|
|
|
| C 3794
|
| K. Pippa
|
| Vol #:
|
| 64
|
|
|
| C 3795
|
| P. Serdenstider
|
| Vol #:
|
| 64
|
|
|
| C 3796
|
| P. Hedeen
|
| Vol #:
|
| 64
|
|
|
| C 3797
|
| S. Jaffe
|
| Vol #:
|
| 64
|
|
|
| C 3798
|
| S. Songer
|
| Vol #:
|
| 64
|
|
|
| C 3799
|
| P. Tyler
|
| Vol #:
|
| 64
|
|
|
| C 3800
|
| Eligible
|
| Vol #:
|
| 64
|
|
|
| C 3801
|
| C. Hexum
|
| Vol #:
|
| 64
|
|
|
| C 3802
|
| B. Maye
|
| Vol #:
|
| 64
|
|
|
| C 3803
|
| J. Heilman
|
| Vol #:
|
| 64
|
|
|
| C 3804
|
| S. Herring
|
| Vol #:
|
| 64
|
|
|
| C 3805
|
| L. Langlois
|
| Vol #:
|
| 64
|
|
|
| C 3806
|
| T. Dobbs
|
| Vol #:
|
| 64
|
|
|
| C 3807
|
| E. Mueller
|
| Vol #:
|
| 65
|
|
|
| C 3808
|
| V. Bean
|
| Vol #:
|
| 65
|
|
|
| C 3809
|
| P. Larson
|
| Vol #:
|
| 65
|
|
|
| C 3810
|
| S. Brent
|
| Vol #:
|
| 65
|
|
|
| C 3811
|
| S. Walbrun
|
| Vol #:
|
| 65
|
|
|
| C 3812
|
| C. Eilandsson
|
| Vol #:
|
| 65
|
|
|
| C 3813
|
| P. Jones
|
| Vol #:
|
| 65
|
|
|
| C 3814
|
| L. Cone
|
| Vol #:
|
| 65
|
|
|
| C 3815
|
| R. Chaves
|
| Vol #:
|
| 65
|
|
|
| C 3816
|
| P. Kuethen
|
| Vol #:
|
| 65
|
|
|
| C 3817
|
| G. Smith
|
| Vol #:
|
| 65
|
|
| | | | | | | |
|
|
| C 3818
|
| W. Wells, RN, FNP
|
| Vol #:
|
| 65
|
|
|
| C 3819
|
| J. Risley
|
| Vol #:
|
| 65
|
|
|
| C 3820
|
| L. Hines
|
| Vol #:
|
| 65
|
|
|
| C 3821
|
| Dr. P. Wannisman
|
| Vol #:
|
| 65
|
|
|
| C 3822
|
| B. Zajaee, DO
|
| Vol #:
|
| 64
|
|
|
| C 3823
|
| B. O'Connor
|
| Vol #:
|
| 65
|
|
|
| C 3824
|
| S. MAris
|
| Vol #:
|
| 65
|
|
|
| C 3825
|
| R. Snoves
|
| Vol #:
|
| 65
|
|
|
| C 3826
|
| S. Schiesser
|
| Vol #:
|
| 65
|
|
|
| C 3827
|
| L. Behnia
|
| Vol #:
|
| 65
|
|
|
| C 3828
|
| C. Ross
|
| Vol #:
|
| 65
|
|
|
| C 3829
|
| C. Banks
|
| Vol #:
|
| 65
|
|
|
| C 3830
|
| C. Bunning
|
| Vol #:
|
| 65
|
|
|
| C 3831
|
| S. McRae
|
| Vol #:
|
| 65
|
|
|
| C 3832
|
| L. Friman
|
| Vol #:
|
| 65
|
|
|
| C 3833
|
| J. Coleman
|
| Vol #:
|
| 65
|
|
|
| C 3834
|
| K. Drucker
|
| Vol #:
|
| 65
|
|
|
| C 3835
|
| D. Wagner, MD
|
| Vol #:
|
| 65
|
|
|
| C 3836
|
| M. Giordano
|
| Vol #:
|
| 65
|
|
|
| C 3837
|
| P. Maccarx
|
| Vol #:
|
| 65
|
|
|
| C 3838
|
| S. Swenson
|
| Vol #:
|
| 65
|
|
|
| C 3839
|
| N. Condon
|
| Vol #:
|
| 65
|
|
|
| C 3840
|
| P. Higowi
|
| Vol #:
|
| 65
|
|
|
| C 3841
|
| Y. Johnson
|
| Vol #:
|
| 65
|
|
|
| C 3842
|
| B. Simmons
|
| Vol #:
|
| 65
|
|
|
| C 3843
|
| M. Gartrell
|
| Vol #:
|
| 65
|
|
|
| C 3844
|
| C. Yoe
|
| Vol #:
|
| 65
|
|
|
| C 3845
|
| E. Nexsen
|
| Vol #:
|
| 65
|
|
|
| C 3846
|
| L. Burtholder
|
| Vol #:
|
| 65
|
|
|
| C 3847
|
| E. Zeusen
|
| Vol #:
|
| 65
|
|
|
| C 3848
|
| L. Cooper
|
| Vol #:
|
| 65
|
|
|
| C 3849
|
| T. Cooper
|
| Vol #:
|
| 65
|
|
|
| C 3850
|
| L. Lindstadt
|
| Vol #:
|
| 65
|
|
|
| C 3851
|
| M. MArler
|
| Vol #:
|
| 65
|
|
|
| C 3852
|
| M. Thorwall
|
| Vol #:
|
| 65
|
|
|
| C 3853
|
| L. Gifford
|
| Vol #:
|
| 65
|
|
|
| C 3854
|
| B. Rollins
|
| Vol #:
|
| 65
|
|
| | | | | | | |
|
|
| C 3855
|
| D. Desmarais
|
| Vol #:
|
| 65
|
|
|
| C 3856
|
| S. Lloyd
|
| Vol #:
|
| 65
|
|
|
| C 3857
|
| J. Berry
|
| Vol #:
|
| 65
|
|
|
| C 3858
|
| M. Toraason
|
| Vol #:
|
| 65
|
|
|
| C 3859
|
| J. Kaye
|
| Vol #:
|
| 65
|
|
|
| C 3860
|
| N. Pollard
|
| Vol #:
|
| 65
|
|
|
| C 3861
|
| L. Chelini
|
| Vol #:
|
| 65
|
|
|
| C 3862
|
| R. Dean
|
| Vol #:
|
| 65
|
|
|
| C 3863
|
| L. Woods
|
| Vol #:
|
| 65
|
|
|
| C 3864
|
| B. Roberts
|
| Vol #:
|
| 65
|
|
|
| C 3865
|
| R. Miller, DO
|
| Vol #:
|
| 65
|
|
|
| C 3866
|
| C. Lindsey
|
| Vol #:
|
| 65
|
|
|
| C 3867
|
| G. Hoskins
|
| Vol #:
|
| 65
|
|
|
| C 3868
|
| C. Casares
|
| Vol #:
|
| 65
|
|
|
| C 3869
|
| L. Rothermich, RN
|
| Vol #:
|
| 65
|
|
|
| C 3870
|
| R. Bleidorn, SSSF
|
| Vol #:
|
| 65
|
|
|
| C 3871
|
| Dr. J. Wallner
|
| Vol #:
|
| 65
|
|
|
| C 3872
|
| S. Kapela
|
| Vol #:
|
| 65
|
|
|
| C 3873
|
| R. Ballard
|
| Vol #:
|
| 65
|
|
|
| C 3874
|
| G. Crows
|
| Vol #:
|
| 65
|
|
|
| C 3875
|
| G. Funderburg
|
| Vol #:
|
| 65
|
|
|
| C 3876
|
| J. Arrington
|
| Vol #:
|
| 65
|
|
|
| C 3877
|
| W. Conley
|
| Vol #:
|
| 65
|
|
|
| C 3878
|
| D. Conley
|
| Vol #:
|
| 65
|
|
|
| C 3879
|
| R. Merk
|
| Vol #:
|
| 65
|
|
|
| C 3880
|
| C. Evans
|
| Vol #:
|
| 65
|
|
|
| C 3881
|
| B. Virruso
|
| Vol #:
|
| 65
|
|
|
| C 3882
|
| K. Price
|
| Vol #:
|
| 65
|
|
|
| C 3883
|
| D. Conley
|
| Vol #:
|
| 65
|
|
|
| C 3884
|
| S. Brown
|
| Vol #:
|
| 65
|
|
|
| C 3885
|
| S. Fontana
|
| Vol #:
|
| 65
|
|
|
| C 3886
|
| Eligible
|
| Vol #:
|
| 65
|
|
|