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| Dockets Entered
On September 2, 2004
Table of Contents
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| Docket #
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| Title
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| 2003E-0147
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| Patent Extension Application for FROVA, No. 5,464,864
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| 2003E-0245
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| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
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| 2003E-0248
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| Patent Extension for Extranaeal (icodextrin), 4,761,237
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| 2003E-0260
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| Patent Extension for Amevive (alefacept), 5,547,853
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| 2004E-0023
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| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| 2004E-0304
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
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| 2004E-0306
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
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| 2004E-0307
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| Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| 2004E-0392
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| Patent Extension for ORAQIX, U.S. Patent No. 6,031,007
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| 2004E-0393
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| Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491
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| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004S-0212
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| Pandemic Influenza Preparedness and Response Plan
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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| 2004V-0358
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| Projector for a Laser Light Show
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| 2003D-0092
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| Food and Cosmetic Security Guidances
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| EC 21
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| home
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| Vol #:
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| 1
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| EC 22
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| Mr. William DuSold
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| Vol #:
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| 1
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| 2003E-0147
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| Patent Extension Application for FROVA, No. 5,464,864
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| LET
5
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0245
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| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
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| LET
5
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0248
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| Patent Extension for Extranaeal (icodextrin), 4,761,237
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| LET
4
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0260
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| Patent Extension for Amevive (alefacept), 5,547,853
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| LET
3
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
5
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| Aventis
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| Vol #:
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| 3
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| C 18
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| H. Bathman, RN
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| Vol #:
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| 1
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| 2004E-0023
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| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| LET
4
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0304
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
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| LET
3
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0306
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
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| LET
3
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0307
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| Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
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| |
|
|
| LET
2
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| |
|
|
| LET
2
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0392
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| Patent Extension for ORAQIX, U.S. Patent No. 6,031,007
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| APP
1
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| DENTSPLY International Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2004E-0393
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| Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491
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| APP
1
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| Sanofi-Synthelabo Inc.
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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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| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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| APP
1
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| Roche Palo Alto LLC
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| APP
1
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| Angiotech Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| C
2
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| Millennium Pharmaceuticals, Inc. (Millennium)
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| Vol #:
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| 1
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| C
3
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| Public Citizen
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| Vol #:
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| 1
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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| C
15
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| Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
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| Vol #:
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| 2
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| C
16
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| American College of Emergency Physicians (ACEP)
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| Vol #:
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| 2
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| C
17
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| American Academy of Orthopaedic Surgeons (AAOS/Academy)
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| Vol #:
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| 2
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| C
3
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| AstraZeneca, LP
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| Vol #:
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| 1
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| C 2
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| L. Wesp
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| Vol #:
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| 1
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| EC
18
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| Cardiff University
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| Vol #:
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| 1
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| AMD
1
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| Dey, L.P.
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| C
1
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| Gold River Parents of Autistic Children
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| Vol #:
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| 1
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| 2004S-0212
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| Pandemic Influenza Preparedness and Response Plan
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| SUP
1
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| HHS
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| Vol #:
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| 3
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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|
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| C
17
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| American Academy of Orthopaedic Surgeons (AAOS/Academy)
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| Vol #:
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| 2
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| 2004V-0358
|
| Projector for a Laser Light Show
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| VRA
1
Attachment A,
B
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| HFZ-300 to Guitar Center #220
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| Vol #:
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| 1
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