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| Dockets Entered
On February 27, 2007
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| Docket #
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| Title
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| 1995N-0220
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| Substances Appoved use in Preparation Meat/Poultry Products
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| |
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| |
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| 2004E-0300
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
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| 2004E-0301
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
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| |
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| 2004E-0302
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| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
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| 2004E-0303
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
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| |
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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-0426
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
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| 2004P-0262
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| Withdraw approval of ANDA suitability petition
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006E-0206
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| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 2007N-0005
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2007V-0067
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| Laser Light Show
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| |
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| 1995N-0220
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| Substances Appoved use in Preparation Meat/Poultry Products
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| NFR 2
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| FDA
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| Vol #:
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| 1
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| |
|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| LET 18942
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| Herbalist & Alchemist, Inc.
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| Vol #:
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| 171
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| |
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| LET 18943
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| Calgenex Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18944
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| World Nutrition, Inc.
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| Vol #:
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| 171
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| |
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| LET 18945
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| Medtech Products, Inc.
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| Vol #:
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| 171
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| | | | | | | |
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| LET 18946
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
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| LET 18947
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18948
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18949
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18950
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
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| LET 18951
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18952
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
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| LET 18953
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18954
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
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| LET 18955
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18956
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18957
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18958
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18959
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18960
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18961
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| New Century Company
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| Vol #:
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| 171
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| |
|
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| LET 18962
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| Virginia Bionutrients, LLC
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| Vol #:
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| 171
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| |
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| LET 18963
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| Iovate Health Sciences U.S.A Inc.
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| Vol #:
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| 171
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| |
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| LET 18964
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| Iovate Health Sciences U.S.A Inc.
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| Vol #:
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| 171
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| |
|
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| LET 18965
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| Iovate Health Sciences U.S.A Inc.
|
| Vol #:
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| 171
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| |
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| LET 18966
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| Iovate Health Sciences U.S.A Inc.
|
| Vol #:
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| 171
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| |
|
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| LET 18967
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| Iovate Health Sciences U.S.A Inc.
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| Vol #:
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| 171
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| |
|
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| LET 18968
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18969
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18970
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18971
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18972
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18973
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18974
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18975
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18976
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18977
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18978
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
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| LET 18979
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18980
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18981
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18982
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| PuraPharm Corporation
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| Vol #:
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| 171
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|
| | | | | | | | |
|
| |
|
| LET 18983
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18984
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18985
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18986
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18987
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18988
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18989
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18990
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18991
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18992
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| PuraPharm Corporation
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| Vol #:
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| 171
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| |
|
|
| LET 18993
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18994
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| PuraPharm Corporation
|
| Vol #:
|
| 171
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| |
|
|
| LET 18995
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18996
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| PuraPharm Corporation
|
| Vol #:
|
| 171
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| |
|
|
| LET 18997
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| PuraPharm Corporation
|
| Vol #:
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| 171
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| |
|
|
| LET 18998
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| PuraPharm Corporation
|
| Vol #:
|
| 171
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| |
|
|
| LET 18999
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| PuraPharm Corporation
|
| Vol #:
|
| 171
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| |
|
|
| LET 19000
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| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19001
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19002
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
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| |
|
|
| LET 19003
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19004
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19005
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19006
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| LET 19007
|
| PuraPharm Corporation
|
| Vol #:
|
| 171
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| C 1409
|
| M. Chisnell
|
| Vol #:
|
| 262
|
|
| |
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C 369
|
| P. Dolinsky
|
| Vol #:
|
| 30
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| C 184
|
| J. Murray
|
| Vol #:
|
| 22
|
| |
|
|
| C 185
|
| G. Tubridy
|
| Vol #:
|
| 22
|
| |
|
|
| C 186
|
| D. Schrader
|
| Vol #:
|
| 22
|
| |
|
|
| C 187
|
| J. Argyle
|
| Vol #:
|
| 22
|
| |
|
|
| C 188
|
| M. Lucas
|
| Vol #:
|
| 22
|
|
| | | | | | | |
|
| |
|
| C 189
|
| A. McAbata
|
| Vol #:
|
| 22
|
| |
|
|
| C 190
|
| S. Gregory
|
| Vol #:
|
| 22
|
| |
|
|
| C 191
|
| S. Berridge
|
| Vol #:
|
| 22
|
| |
|
|
| C 192
|
| J. Magee
|
| Vol #:
|
| 22
|
| |
|
|
| C 193
|
| E. Snyder
|
| Vol #:
|
| 22
|
| |
|
|
| C 194
|
| W. Zadan
|
| Vol #:
|
| 22
|
| |
|
|
| C 195
|
| P. Nelson
|
| Vol #:
|
| 22
|
| |
|
|
| C 196
|
| S. Farrell
|
| Vol #:
|
| 22
|
| |
|
|
| C 197
|
| C. Ritch
|
| Vol #:
|
| 22
|
| |
|
|
| C 198
|
| J. Brinckloe
|
| Vol #:
|
| 22
|
| |
|
|
| C 199
|
| J. Bush
|
| Vol #:
|
| 22
|
| |
|
|
| C 200
|
| F. Steel
|
| Vol #:
|
| 22
|
| |
|
|
| C 201
|
| S. Willhite
|
| Vol #:
|
| 22
|
| |
|
|
| C 202
|
| K. Waring
|
| Vol #:
|
| 22
|
| |
|
|
| C 203
|
| W.Bolker
|
| Vol #:
|
| 22
|
| |
|
|
| C 204
|
| B.Barr
|
| Vol #:
|
| 22
|
| |
|
|
| C 205
|
| D. Dennenberg
|
| Vol #:
|
| 22
|
| |
|
|
| C 206
|
| A. Chournard-Welk
|
| Vol #:
|
| 22
|
| |
|
|
| C 207
|
| J. Speed
|
| Vol #:
|
| 22
|
| |
|
|
| C 208
|
| J. Raview
|
| Vol #:
|
| 22
|
| |
|
|
| C 209
|
| J. Perret
|
| Vol #:
|
| 22
|
| |
|
|
| C 210
|
| E. Stuparyk
|
| Vol #:
|
| 22
|
| |
|
|
| C 211
|
| B. Mikita
|
| Vol #:
|
| 22
|
| |
|
|
| C 212
|
| P. Spigner
|
| Vol #:
|
| 22
|
| |
|
|
| C 213
|
| J. Urbanik
|
| Vol #:
|
| 22
|
| |
|
|
| C 214
|
| J. Convery
|
| Vol #:
|
| 22
|
| |
|
|
| C 215
|
| J. Convery
|
| Vol #:
|
| 22
|
| |
|
|
| C 216
|
| L. Bailly
|
| Vol #:
|
| 22
|
| |
|
|
| C 217
|
| V. Girardi Jr
|
| Vol #:
|
| 22
|
| |
|
|
| C 218
|
| L. Pierce
|
| Vol #:
|
| 22
|
| |
|
|
| C 219
|
| A> Roche
|
| Vol #:
|
| 22
|
| |
|
|
| C 220
|
| J. Homeister
|
| Vol #:
|
| 22
|
| |
|
|
| C 221
|
| T. Ramsdell
|
| Vol #:
|
| 22
|
| |
|
|
| C 222
|
| J. Arnold
|
| Vol #:
|
| 22
|
| |
|
|
| C 223
|
| P. McHugh
|
| Vol #:
|
| 22
|
| |
|
|
| C 224
|
| G. Vorhies
|
| Vol #:
|
| 22
|
| |
|
|
| EXT 1
|
| H.Hellberg
|
| Vol #:
|
| 22
|
|
| | | | | | | | |
|
| |
|
| EXT 2
|
| C. Waldrop
|
| Vol #:
|
| 22
|
| |
|
|
| EXT 3
|
| R. Brillinger
|
| Vol #:
|
| 22
|
|
| |
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
| |
|
|
| C 74
|
| M. Chisnell
|
| Vol #:
|
| 5
|
| |
|
|
| 2004E-0300
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0301
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0302
|
| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0303
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0304
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0306
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2004E-0426
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0262
|
| Withdraw approval of ANDA suitability petition
|
| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| C 675
|
| J. Mellan
|
| Vol #:
|
| 32
|
| |
|
|
| C 676
|
| A. Meyer
|
| Vol #:
|
| 32
|
| |
|
|
| C 677
|
| B. Stewart
|
| Vol #:
|
| 32
|
| |
|
|
| C 678
|
| C. Bonnie
|
| Vol #:
|
| 32
|
| |
|
|
| C 679
|
| Cornell University
|
| Vol #:
|
| 32
|
| |
|
|
| C 680
|
| J. Opatrny
|
| Vol #:
|
| 32
|
| |
|
|
| C 681
|
| M. Freundlich
|
| Vol #:
|
| 32
|
| |
|
|
| C 682
|
| R. Gilbert
|
| Vol #:
|
| 32
|
| |
|
|
| C 683
|
| J. Lopez
|
| Vol #:
|
| 32
|
| |
|
|
| C 684
|
| G. Opatrny
|
| Vol #:
|
| 32
|
|
| | | | | | | | |
|
| |
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| C 685
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| J. Johnston
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| Vol #:
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| 32
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| EC 1646
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| Ms. Marya Bruning
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| Vol #:
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| 31
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| EC 1647
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| Mrs. Judy Pearson-Wright
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| Vol #:
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| 31
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| |
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| EC 1648
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| Ms. nina ferguson
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| Vol #:
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| 31
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| |
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| EC 1649
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| Alamo Celiac
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| Vol #:
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| 31
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| |
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| EC 1650
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| Ms. Diane Theuer
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| Vol #:
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| 31
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| |
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| EC 1651
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| Mrs. W Wiswell
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| Vol #:
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| 31
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| |
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| EC 1652
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| North Texas Gluten Intolerance Group
|
| Vol #:
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| 31
|
| |
|
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| EC 1653
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| Mrs. Tina Barad
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| Vol #:
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| 31
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| |
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| EC 1654
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| Celiac Awareness
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| Vol #:
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| 31
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| |
|
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| EC 1655
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| Mrs. Claire Fisher
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| Vol #:
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| 31
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| |
|
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| EC 1656
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| Ms. Lisa Licavoli
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| Vol #:
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| 31
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| |
|
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| EC 1657
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| Ms. Holly Schneider
|
| Vol #:
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| 31
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| |
|
|
| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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| EC 53
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| UCSD School of Medicine
|
| Vol #:
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| 4
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| |
|
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| EC 54
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| FedEx Trade Networks
|
| Vol #:
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| 4
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| |
|
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| EC 55
|
| Ms. Jennifer Watson
|
| Vol #:
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| 4
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| |
|
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| EC 56
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| City of Hope
|
| Vol #:
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| 4
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| EC 33274
|
| Mrs. Pamela Gore
|
| Vol #:
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| 197
|
| |
|
|
| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
|
| |
|
|
| C 13
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| Pactiv Corporation
|
| Vol #:
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| 7
|
| |
|
|
| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
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|
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| |
|
|
| C 1592
|
| E. Lum
|
| Vol #:
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| 46
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| |
|
|
| C 1593
|
| J. Davis
|
| Vol #:
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| 46
|
| |
|
|
| C 1594
|
| C. Knop
|
| Vol #:
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| 46
|
| |
|
|
| C 1595
|
| J. Manidis
|
| Vol #:
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| 46
|
| |
|
|
| C 1596
|
| T. Manidis
|
| Vol #:
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| 46
|
| |
|
|
| C 1597
|
| S. Canady
|
| Vol #:
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| 46
|
| |
|
|
| C 1598
|
| J. Benrich
|
| Vol #:
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| 46
|
| |
|
|
| C 1599
|
| E. & R. Spaeth
|
| Vol #:
|
| 46
|
| |
|
|
| 2006E-0206
|
| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
|
|
| | | | | | | | |
|
| |
|
| N 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006E-0261
|
| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2006E-0355
|
| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0356
|
| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| LET 10
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| FDA to Honorable Dennis Moore, U.S. House of Representatives
|
| Vol #:
|
| 36
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 57
|
| N. Jones
|
| Vol #:
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| 6
|
| |
|
|
| C 58
|
| C. Whitaub
|
| Vol #:
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| 6
|
| |
|
|
| C 59
|
| M. Carter
|
| Vol #:
|
| 6
|
| |
|
|
| C 60
|
| P. Bertsch
|
| Vol #:
|
| 6
|
|
| |
|
| 2006P-0410
|
| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
|
| |
|
|
| C 4
|
| Sun Pharmaceutical Industries, Ltd.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0005
|
| Prescription Drug User Fee Act (PDUFA): Public Meeting
|
| |
|
|
| C 2
|
| Sepracor
|
| Vol #:
|
| 2
|
| |
|
|
| 2007V-0067
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA / DDM to Aqua Night Club
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Aqua Night Club
|
| Vol #:
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| 1
|
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|
