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| Dockets Entered
On April 20, 2005
Table of Contents
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| Docket #
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| Title
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| 1998V-0868
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| Variance of the Lasette Finger Perforator.
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| 1999P-1654
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| Stay Effect Date for Approval of ANDA for generic DIPRIVAN
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| 2004P-0285
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| To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| 2004P-0365
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| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
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| 2004P-0504
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| ANDA for DiaBeta (glyburide) Tablets, 5 mg
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| 2005N-0105
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| Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
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| 1998V-0868
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| Variance of the Lasette Finger Perforator.
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| EXP 1
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| Cell Robotics, Inc.
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| Vol #:
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| 1
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| 1999P-1654
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| Stay Effect Date for Approval of ANDA for generic DIPRIVAN
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| PDN
1
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| HF-22 to AstraZeneca Pharmaceuticals LP
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| Vol #:
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| 3
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| EMC 465
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| Mike & Erica
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| Vol #:
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| 4
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| EMC 466
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| D. Wilson
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| Vol #:
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| 4
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| EMC 467
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| J. Schofill
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| Vol #:
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| 4
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| EMC 468
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| unsign
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| Vol #:
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| 4
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| EMC 469
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| S. Baxter
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| Vol #:
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| 4
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| EMC 470
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| S. Lash
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| Vol #:
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| 4
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| EMC 471
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| unsign
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| Vol #:
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| 4
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| EMC 472
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| V. Blake
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| Vol #:
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| 4
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| EMC 473
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| S. Cox
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| Vol #:
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| 4
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| EMC 474
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| J. Hilliard
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| Vol #:
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| 4
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| EMC 475
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| L. Becker
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| Vol #:
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| 4
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| EMC 476
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| J. Stromsdorfer
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| Vol #:
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| 4
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| EMC 477
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| M. Isbell
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| Vol #:
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| 4
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| EMC 478
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| B. O'Brien
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| Vol #:
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| 4
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| EMC 479
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| unsign
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| Vol #:
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| 4
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| EMC 480
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| E. A. Orasco
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| Vol #:
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| 4
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| EMC
481
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| Rob Bailey Communications, Inc
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| Vol #:
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| 4
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| EMC 482
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| D. Kindoll
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| Vol #:
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| 4
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| EMC 483
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| V. Bhatia
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| Vol #:
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| 4
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| EMC 521
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| C. Sokoloff
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| Vol #:
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| 4
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| EMC 522
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| P. Libby
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| Vol #:
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| 4
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| EMC 523
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| A. Guthrie
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| Vol #:
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| 11
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| EMC 524
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| C. J. Borter
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| Vol #:
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| 4
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| EMC 525
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| The Grothmans
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| Vol #:
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| 4
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| EMC 526
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| unsign
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| Vol #:
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| 4
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| EMC 527
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| J.Marceaux
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| Vol #:
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| 4
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| EMC 528
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| C. Carolyn
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| Vol #:
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| 4
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| EMC 529
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| C. Zulkey
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| Vol #:
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| 4
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| EMC 530
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| G. Navratil
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| Vol #:
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| 4
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| EMC 531
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| M. Marie
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| Vol #:
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| 4
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| EMC 532
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| N. Thatcher
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| Vol #:
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| 4
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| EMC 533
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| L. Novak
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| Vol #:
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| 4
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| EMC 534
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| unsign
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| Vol #:
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| 4
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| EMC 535
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| unsign
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| Vol #:
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| 4
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| 2004P-0068
|
| Establish specific bioequivalence requirements for oral products contanining desmopressin
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|
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| LET
2
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| Ferring Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| SUP
1
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| Ferring Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004P-0285
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| To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
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|
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|
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| LET
2
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| HFD-7 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| LET 2
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| R. J. Thomsen, M.D.
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| Vol #:
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| 1
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| 2004P-0365
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| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
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|
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| PDN
1
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| HF-22 to Shire US, Inc.
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| Vol #:
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| 2
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| 2004P-0504
|
| ANDA for DiaBeta (glyburide) Tablets, 5 mg
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|
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| PAV
1
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| HFD-7 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005N-0105
|
| Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
|
|
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| LET
1
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| HFD-7 to James T. Kimball
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| Vol #:
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| 1
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