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| Dockets Entered
On January 14, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
|
| |
|
|
| 1995V-0312
|
| Laser Light Show
|
| |
|
|
| 1997N-0484S
|
| Human Cellular and Tissue-Based Products
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
| |
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
| |
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
| |
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| 1999P-4613
|
| Revoke the Regulation That Approved Posilac
|
| |
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
| |
|
|
| 2000D-1267
|
| Recommendations for Donor Questioning Regarding Malaria
|
| |
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
| |
|
|
| 2003M-0569
|
| Premarket Approval, D980003, Keramos Ceramic/Ceramic Total Hip System
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| |
|
|
| 2003N-0311
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| Agency Information Collection Activities: Proposed Collection; Comment Request; MDUFMA Small Business Qualification Certification (Form FDA 3602)
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| |
|
|
| 2003N-0361
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| Anti-Counterfeit Drug Initiative
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| 2004E-0011
|
| Patenet Term Extention of U.S. patent No. 5,198,533 for Cetrotied (cetrorelix acetate)
|
| |
|
|
| 2004E-0021
|
| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
|
| |
|
|
| 2004E-0023
|
| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
|
| |
|
|
| 2004V-0020
|
| Laser Display Device
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| RPT
13
Attachment
1, 2, 3,
4, 5,
6, 7,
8, 9,
10, 11,
12, 13
|
| Northfield Laboratories
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| Vol #:
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| 21
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| |
|
|
| 1995V-0312
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| Laser Light Show
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| | | | | | | | |
| |
|
|
| VRA
7
|
| HFZ-300 to Laseronics Northwest
|
| Vol #:
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| 1
|
| |
|
|
| 1997N-0484S
|
| Human Cellular and Tissue-Based Products
|
| |
|
|
| EMC 29
|
| S. Berte
|
| Vol #:
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| 27
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
12291
|
| Jarrow Formulas, Inc.
|
| Vol #:
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| 99
|
| |
|
|
| LET
12292
|
| Jarrow Formulas, Inc.
|
| Vol #:
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| 99
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| |
|
|
| LET
12293
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
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| |
|
|
| LET
12294
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12295
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| EMC 4061
|
| M. Raiford
|
| Vol #:
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| 304
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| |
|
|
| EMC 4062
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| C. Bencze
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| Vol #:
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| 304
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| |
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| EMC 4063
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| P. Rotz
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| Vol #:
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| 304
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| |
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| EMC 4064
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| J. Gordon
|
| Vol #:
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| 304
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| |
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| EMC 4065
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| E. Ayala
|
| Vol #:
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| 304
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| |
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|
| EMC 4066
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| V. Silano
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4067
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| B. Lensing
|
| Vol #:
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| 304
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| |
|
|
| EMC 4068
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| M. Rollins
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| Vol #:
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| 304
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| |
|
|
| EMC 4069
|
| K. Francis
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4070
|
| No signature
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4071
|
| P. Hermsdorfer
|
| Vol #:
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| 304
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| |
|
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| EMC 4072
|
| L. Dietterick
|
| Vol #:
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| 304
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| |
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| EMC 4073
|
| S.J. Socolar
|
| Vol #:
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| 304
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| |
|
|
| EMC 4074
|
| T. Jordan
|
| Vol #:
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| 304
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| |
|
|
| EMC 4075
|
| B. Horton
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4076
|
| T. Young
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4077
|
| L. Trammell
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4078
|
| S. Shrewsbury
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4079
|
| C. Kendall
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4080
|
| R. Cross
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4081
|
| C. Ellenwood
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4082
|
| M. Davidson
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4083
|
| P. Powers
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4084
|
| P. Powers
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4085
|
| E. Grasmuck
|
| Vol #:
|
| 304
|
|
| | | | | | | | |
| |
|
|
| EMC 4086
|
| N. Mitchell
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4087
|
| C. Lenon
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4088
|
| G. Campbell
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4089
|
| E.K. Kyle
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4090
|
| L. Gamblin
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4091
|
| M. Schilder
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4092
|
| S. Mathier
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4093
|
| S. Taubman
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4094
|
| J. & R. Cass
|
| Vol #:
|
| 304
|
| |
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
| |
|
|
| EMC 454
|
| T. Severyn
|
| Vol #:
|
| 8
|
| |
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
| |
|
|
| EMC 357
|
| T. Severyn
|
| Vol #:
|
| 8
|
| |
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
| |
|
|
| EMC 356
|
| T. Severyn
|
| Vol #:
|
| 6
|
| |
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
| |
|
|
| EMC 359
|
| T. Severyn
|
| Vol #:
|
| 6
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| EMC 4112
|
| K. Norton
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4113
|
| S. Freeman
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4114
|
| S. Freeman
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4115
|
| J. Repati
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4116
|
| M. Whitfield
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4117
|
| M. Whitfield
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4118
|
| M. Whitfield
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4119
|
| M. Whitfield
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4120
|
| B. Hatfield
|
| Vol #:
|
| 515
|
| |
|
|
| EMC 4121
|
| N. Beaven
|
| Vol #:
|
| 515
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 502
|
| J. Sheehy
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 503
|
| J. Martin
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 504
|
| H. Miller
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 505
|
| P. Evans
|
| Vol #:
|
| 24
|
|
| | | | | | | | |
| |
|
|
| EMC 506
|
| J. Martin
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 507
|
| No signature
|
| Vol #:
|
| 24
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 740
|
| R. Pingatore
|
| Vol #:
|
| 40
|
| |
|
|
| EMC 741
|
| M. Hunnibell
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 742
|
| B.S. Borgeson
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 743
|
| K. Guttman
|
| Vol #:
|
| 33
|
| |
|
|
| 1999P-4613
|
| Revoke the Regulation That Approved Posilac
|
| |
|
|
| EMC 2423
|
| R.T. Cumberland
|
| Vol #:
|
| 46
|
| |
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
| |
|
|
| EMC 152
|
| No signature
|
| Vol #:
|
| 2
|
| |
|
|
| 2000D-1267
|
| Recommendations for Donor Questioning Regarding Malaria
|
| |
|
|
| EMC
2
|
| American Assn of Blood Banks (AABB)
|
| Vol #:
|
| 1
|
| |
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
| |
|
|
| EMC 461
|
| T. Severyn
|
| Vol #:
|
| 8
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 2813
|
| No signature
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2814
|
| No signature
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2815
|
| C. Revoir
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2816
|
| H. McCarrey
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2817
|
| J.M. Lagos
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2818
|
| D. Warlick
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2819
|
| Inna B.
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2820
|
| P. Midney
|
| Vol #:
|
| 130
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 142
|
| L. Markowski
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 143
|
| S. Meehan
|
| Vol #:
|
| 3
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 298
|
| Dr. B. Martini
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 299
|
| Dr. B. Martini
|
| Vol #:
|
| 5
|
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
| | | | | | | | |
| |
|
|
| EMC 4
|
| L.A. Harbour
|
| Vol #:
|
| 1
|
| |
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
| |
|
|
| LET
2
|
| GCF-1
|
| Vol #:
|
| 1
|
| |
|
|
| 2003M-0569
|
| Premarket Approval, D980003, Keramos Ceramic/Ceramic Total Hip System
|
| |
|
|
| AAV
1
Approval
Order,
SS & E,
Labeling
|
| Encore Medical, L.P.
|
| Vol #:
|
| 1
|
| |
|
|
| SS 1
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 122
|
| M. Glueckert
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 123
|
| A. Ratermann
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 124
|
| No signature
|
| Vol #:
|
| 3
|
| |
|
|
| 2003N-0311
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; MDUFMA Small Business Qualification Certification (Form FDA 3602)
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
|
| EMC 43
|
| I.M. Avcioglu
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
44
Attachment
|
| NACDS
|
| Vol #:
|
| 7
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| EMC 17
|
| S.A. Sims, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 18
|
| S.A. Sims, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 19
|
| P. Milner,PhD, CCC-A
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 20
|
| D.I. Gross, AuD, CCC, FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
21
Attachment
|
| Audiology Associates, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| EMC 4
|
| S.A. Sims, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 5
|
| S.A. Sims, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 6
|
| P. Milner,PhD, CCC-A
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 7
|
| D.I. Gross, AuD,CCC,FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
8
Attachment
|
| Audiology Associates, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
| |
|
|
| EMC 23
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 24
|
| W. Arrigoni
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 25
|
| D.A. Brown
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC 26
|
| N. Kilkeary
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 27
|
| J. Terry
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 28
|
| P. Cockle
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 29
|
| P. Dietel
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 30
|
| T.J. Rowan
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 31
|
| No signature
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 32
|
| S. Brady
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0011
|
| Patenet Term Extention of U.S. patent No. 5,198,533 for Cetrotied (cetrorelix acetate)
|
| |
|
|
| APP 1
|
| Tulane
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0021
|
| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
|
| |
|
|
| APP 1
|
| Genetech
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| United States Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0023
|
| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| APP 1
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| Novartis Finance Corporation
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| Vol #:
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| 1
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| LET 1
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| United States Patent & Trademark Office
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| Vol #:
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| 1
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| 2004V-0020
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| Laser Display Device
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| ACK 1
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| HFA-305 to Stealth DJ's Mobile Disc
Jockey Services
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| Vol #:
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| 1
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