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| Dockets Entered
On March 7, 2005
Table of Contents
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| Docket #
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| Title
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0484
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| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| 2004N-0401
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0498
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
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| 2004N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0320
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| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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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-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2004P-0563
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| re-evaluate FDA's policy concening the marketing of "authorized generic" versions of brand name prescription drugs.
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| 2005A-0014
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| Regarding hip joint metal constrained
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| 2005N-0010
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| High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005N-0058
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| Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| 2005V-0009
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| Projector for a Laser Light Show
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| C 12808
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| Jack Ferguson
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| Vol #:
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| 802
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| GDL
5
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
5
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| FDA
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1301
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| B Cagnoni
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| Vol #:
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| 18
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| EMC 1302
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| M Barclay
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| Vol #:
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| 18
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| EMC 1303
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| C Hoex
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| Vol #:
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| 18
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| EMC 1341
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| S Prince
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| Vol #:
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| 18
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| EMC
1342
Attachment
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| Church Development Service, Institute of Agriculture and Trade Policy, Gene Campaign
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| Vol #:
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| 18
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| EMC
1343
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| Ciranda Inc
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| Vol #:
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| 18
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| EMC
1344
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| Friends of the Earth
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| Vol #:
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| 18
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| EMC
1345
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| Edmonds Institute
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| Vol #:
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| 18
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| EMC
1346
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| The Consumers Party
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| Vol #:
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| 18
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| EMC 1347
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| J Newcomb
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| Vol #:
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| 18
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| EMC 1348
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| J Leiss
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| Vol #:
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| 18
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| EMC
1349
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| Independent Science Panel
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| Vol #:
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| 18
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| EMC 1350
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| Number not used
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| Vol #:
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| 18
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| EMC 1351
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| G Miranda
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| Vol #:
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| 18
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| EMC
1352
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| Snohomish County Solid Waste Management Division
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| Vol #:
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| 18
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| EMC
1353
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| Center for environmental Health
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| Vol #:
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| 18
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| EMC 1354
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| B Houston
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| Vol #:
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| 18
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| EMC 1355
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| T Freedman
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| Vol #:
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| 18
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| EMC
1356
Attachment
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| Church Development Service, Institute for Agriculture and Trade Policy, Gene Campaign
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| Vol #:
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| 18
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| EMC 1357
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| D Shively
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| Vol #:
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| 18
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| EMC 1358
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| C Bondy
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| Vol #:
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| 18
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| EMC 1359
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| M Sorkin
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| Vol #:
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| 18
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| EMC
1360
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| Living Well Health Center
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| Vol #:
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| 18
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| EMC 1361
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| T Niernberger
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| Vol #:
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| 18
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| EMC 1362
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| R Roo
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| Vol #:
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| 18
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| EMC
1363
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| California Sustainable Agriculture Working Group
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| Vol #:
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| 18
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| EMC 1364
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| D Weiss
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| Vol #:
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| 18
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| EMC 1365
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| A Decherd
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| Vol #:
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| 18
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| EMC 1366
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| M Baxter
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| Vol #:
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| 18
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| EMC 1367
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| I Emming
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| Vol #:
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| 18
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| EMC 1368
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| T Thralls
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| Vol #:
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| 18
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| EMC 1369
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| T Simpson
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| Vol #:
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| 18
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| 2004D-0484
|
| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| C
2
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| ViroLogic
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| Vol #:
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| 1
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| C
3
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| VircoLab Inc.
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| Vol #:
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| 1
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| C
4
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| Bristol-Myers Squibb Company (BMS)
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| Vol #:
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| 1
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| C
5
Appendix
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| Gilead Sciences, Inc. (Gilead)
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| Vol #:
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| 1
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| 2004N-0401
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
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| | | | | | | | |
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C
164
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| American Herbal Products Assn (AHPA)
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| Vol #:
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| 31
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| 2004N-0498
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| C
2
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| C
3
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| RC
1
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| Genentech, Inc
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| Vol #:
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| 2
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| C
13
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| Nutriant
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| Vol #:
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| 5
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| C
14
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| Honorable Jack Kingston
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| Vol #:
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| 5
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| C
15
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| Honorable Ernest J. Istook, Jr.
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| Vol #:
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| 5
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| 2004P-0320
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| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
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| RC
1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| C 7
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| S. Goldstone, MD, FACS
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| Vol #:
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| 1
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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
1
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| HFD-005 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
1
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| HFD-005 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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| LET
1
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| HFD-005 to Gerald Austin c/o Eva Kasparova
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| Vol #:
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| 1
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| RC
1
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| IVAX Pharmaceuticals, Inc.
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| Vol #:
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| 1
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|
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| 2004P-0563
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| re-evaluate FDA's policy concening the marketing of "authorized generic" versions of brand name prescription drugs.
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| | | | | | | | |
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| C
1
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| McNeil Consumer & Specialty Pharmaceuticals (McNeil)
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| Vol #:
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| 1
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| 2005A-0014
|
| Regarding hip joint metal constrained
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| EXT 1
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| Bill G. Pierson #907177
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| Vol #:
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| 1
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| 2005N-0010
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| High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
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|
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| LET
2
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| Bayer HealthCare, LLC
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| Vol #:
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| 1
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| APE 7
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| Council for International Organization of Medical Sciences (CIOMS)
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| Vol #:
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| 1
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| EAPE 177
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| Patel, Rita
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| Vol #:
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| 1
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| EAPE 178
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| Madarelli, Frank
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| Vol #:
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| 1
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| EAPE 179
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| Madarelli, Frank
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| Vol #:
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| 1
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| EAPE 180
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| Freeman, John
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| Vol #:
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| 1
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| EAPE 181
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| Kieswetter, Caren
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| Vol #:
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| 1
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| EAPE 182
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| Swanson, Dennis
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| Vol #:
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| 1
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| EAPE 183
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| Bankert, Elizabeth
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| Vol #:
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| 1
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| EAPE 184
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| Taylor-Zapata, Perdita
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| Vol #:
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| 1
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| EAPE 185
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| Goldhammer, Alan
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| Vol #:
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| 1
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| EAPE 186
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| boyd, Richardo
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| Vol #:
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| 1
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| EAPE 187
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| Saillot, Jean-Louis
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| Vol #:
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| 1
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| EAPE 188
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| Roehr, Bob
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| Vol #:
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| 1
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| EAPE 189
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| Kasprzak, Constance
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| Vol #:
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| 1
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|
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|
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| 2005N-0058
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| Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications
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|
|
|
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| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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|
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| NRD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
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| 2005P-0095
|
| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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|
|
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| ACK
1
|
| HFA-305 to Luitpold Pharmaceuticals, Inc.
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| Vol #:
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| 1
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|
|
|
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| 2005V-0009
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| Projector for a Laser Light Show
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|
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| VRA
1
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| HFZ-300 to Patrick Kane
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| Vol #:
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| 1
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