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| Dockets Entered
On January 17, 2006
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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| 1998D-0834
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| Non-Contraceptive Estrogen Class Labeling
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2001N-0322
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| Institutional Review Boards
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2004P-0406
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| Distribution of Betamethasone Sodium Phosphate plus Betamethasone Acetate was withdrawn withdrawn for safety reasons
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| 2004P-0407
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| Withdrawn of Bethamethasone Sodium Phosphate was withdrawn for safety reasons
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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| 2006M-0014
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| St. Francis Medical Technologies, Inc, Premarket Approval for X STOP Interspinous Process Decompression System, P040001
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| 2006M-0015
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| Biomet Manufacturing Corporation, Premarket Approval of C2a-Taper Acetabular System, P050009
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| 2006M-0016
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| Abbott Vascular Devices (AVD), Premarket Approval of StarClose Vascular Closure System, P050007
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17102
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| Immunocorp
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| Vol #:
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| 155
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| LET
17103
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| NBTY Inc.
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| Vol #:
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| 155
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| LET
17104
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| Swanson Health Products
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| Vol #:
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| 155
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| LET
17105
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| Swanson Health Products
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| Vol #:
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| 155
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| LET
17106
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| RKS Inc.
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| Vol #:
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| 155
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| LET
17107
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| Swanson Health Products
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| Vol #:
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| 155
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| LET
17108
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| Swanson Health Products
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| Vol #:
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| 155
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| LET
17109
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| Infinity2, Inc.
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| Vol #:
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| 155
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| LET
17110
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| Natrol, Inc.
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| Vol #:
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| 155
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| 1998D-0834
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| Non-Contraceptive Estrogen Class Labeling
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| C
20
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| Wyeth Research
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| Vol #:
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| 5
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C
80
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| North AMerican Milk Products (NAMP)
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| Vol #:
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| 2
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| C
81
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| Southeast Milk, Inc. (SMI)
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| Vol #:
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| 2
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| C
82
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| Select Milk Producers (Select)
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| Vol #:
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| 2
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| C 83
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| F. Baffi
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| Vol #:
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| 2
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| C
84
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| Dairy Australia
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| Vol #:
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| 2
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| C
85
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| University of Wisconsin's Center for Dairy Research (CDR)
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| Vol #:
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| 26
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| 2001N-0322
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| Institutional Review Boards
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| NWL
1
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| FDA
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| Vol #:
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| 2
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C 524
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| P. Tucker
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| Vol #:
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| 45
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| C 525
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| R and K Sonus
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| Vol #:
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| 45
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| LET
6
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| Honorable Paul E. Kanjorski
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| Vol #:
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| 45
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| LET
7
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| Honorable Barbara A. Mikulski
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| Vol #:
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| 45
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C 45
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| A. Velte
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| Vol #:
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| 2
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| C
19
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| Hard of Hearing Advocates
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| Vol #:
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| 2
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| 2004P-0406
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| Distribution of Betamethasone Sodium Phosphate plus Betamethasone Acetate was withdrawn withdrawn for safety reasons
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| LET
2
Attached
FR
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| HFD-007 to Hikma Farmaceutica (Portugal), Lda
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| Vol #:
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| 1
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| 2004P-0407
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| Withdrawn of Bethamethasone Sodium Phosphate was withdrawn for safety reasons
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| LET
2
Attached
FR
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| HFD-007 to Hikma Farmaceutica (Portugal), Lda
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| Vol #:
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| 1
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| PDN
1
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| HFD-001 to Eva Kasparova
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| Vol #:
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| 1
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| LET
3
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| Hogan & Hartson, LLP
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| Vol #:
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| 3
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| |
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| GDL
1
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| Giudance
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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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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C
46
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| National Institutes of Health (NIH)
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| Vol #:
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| 4
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| C
47
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| AABB
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| Vol #:
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| 4
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| C
48
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| Community Blood Center of the Ozarks (CBCO)
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| Vol #:
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| 4
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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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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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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| APP
1
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| Southern Research Institute
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET
2
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006M-0014
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| St. Francis Medical Technologies, Inc, Premarket Approval for X STOP Interspinous Process Decompression System, P040001
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| AAV
1
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| St. Francis Medical Technologies, Inc.
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| Vol #:
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| 1
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| 2006M-0015
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| Biomet Manufacturing Corporation, Premarket Approval of C2a-Taper Acetabular System, P050009
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| AAV
1
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| Biomet Manufacturing Corporation
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| Vol #:
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| 1
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| 2006M-0016
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| Abbott Vascular Devices (AVD), Premarket Approval of StarClose Vascular Closure System, P050007
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| AAV
1
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| Abbott Vascular Devices
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| Vol #:
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| 1
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