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| Dockets Entered On February
28, 2006
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| |
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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| 2003E-0146
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| Patent Extension Application for RELPAX, No. 5,545,644
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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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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| 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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| |
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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| |
|
|
| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| |
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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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| |
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| 2005E-0251
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| 2005E-0252
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
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| |
|
|
| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| |
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| |
|
|
| 2005N-0510
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| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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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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| |
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|
| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| |
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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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| |
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| 2005P-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| |
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| 2006E-0008
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| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| |
|
|
| 2006E-0026
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| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| |
|
|
| 2006E-0035
|
| Patent Extension Application for ZEGERID (omeprazole), U.S. Patent No. 6,489,346
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| |
|
|
| 2006E-0040
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| Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
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| |
|
|
| 2006E-0043
|
| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990
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| |
|
|
| 2006P-0089
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| Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
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| |
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| |
|
|
| 1980N-0208
|
| Biological Products; Bacterial Vaccines and Toxiods
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|
| | | | | | | | |
| |
|
|
| EMC 228
|
| P. Kelly
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| Vol #:
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| 156
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 18
|
| R. Hall
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| Vol #:
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| 3
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| EMC 19
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| A. Beyer
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| Vol #:
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| 3
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| EMC 629
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| B. Hoover
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| Vol #:
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| 24
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| EMC 630
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| S. Moody
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| Vol #:
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| 24
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 215
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| K. Boyd
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| Vol #:
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| 3
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1311
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| K. Rebbetoy
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| Vol #:
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| 6
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC
610
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| Calorie Control Council
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| Vol #:
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| 9
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| EMC 611
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| Mission Possible International
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| Vol #:
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| 9
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|
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| 2003E-0146
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| Patent Extension Application for RELPAX, No. 5,545,644
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| |
|
|
| LET 3
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
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|
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
|
| |
|
|
| LET 5
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| |
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| EMC 1237
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| P. Belair
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| Vol #:
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| 12
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| EMC 1238
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| F. Jolly
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| Vol #:
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| 12
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| EMC 1239
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| I. Polyakov
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| Vol #:
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| 12
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| EMC 1240
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| A. Anastasio
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| Vol #:
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| 12
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| EMC 1241
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| P. Dreas
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| Vol #:
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| 12
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| EMC 1242
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| P. Dreas
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| Vol #:
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| 12
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| |
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| EMC 1243
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| S. Butler
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| Vol #:
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| 12
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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
|
| |
|
|
| LET 3
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2004E-0303
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
|
| |
|
|
| LET 3
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
| | | | | | | | |
| |
|
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| 2004E-0304
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
|
| |
|
|
| LET 5
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 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
|
| |
|
|
| LET 5
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2004E-0308
|
| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
|
| |
|
|
| LET 2
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2004E-0396
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| Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)
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| |
|
|
| LET 2
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 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
|
| |
|
|
| LET 3
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2005E-0251
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
|
| |
|
|
| LET 4
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2005E-0252
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
|
| |
|
|
| LET 4
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| HFD-5 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
| |
|
|
| EMC
562
Attachment
|
| Davidson & Company
|
| Vol #:
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| 12
|
| |
|
|
| EMC
563
Attachment
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| Respironics
|
| Vol #:
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| 12
|
|
| |
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
| |
|
|
| EMC 7
|
| J. Stevenson
|
| Vol #:
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| 1
|
| |
|
|
| EMC 8
|
| L. Sasscer
|
| Vol #:
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| 1
|
| |
|
|
| EMC 9
|
| No siganture
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 10
|
| B. Short
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0510
|
| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
|
| |
|
|
| C
1
|
| American Free Trade Association (AFTA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
Attachment
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| PDMA Alliance Inc. (Alliance)
|
| Vol #:
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| 1
|
| |
|
|
| C
3
|
| UPS Supply Chain Solutions (UPS SCS)
|
| Vol #:
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| 1
|
| |
|
|
| C
4
|
| Cardinal Health
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 1331
|
| M. Shortt
|
| Vol #:
|
| 26
|
| |
|
|
| C 1332
|
| C. Clute
|
| Vol #:
|
| 26
|
| |
|
|
| C 1333
|
| K. Koch
|
| Vol #:
|
| 26
|
|
| | | | | | | |
| |
|
|
| C 1334
|
| M. Settle
|
| Vol #:
|
| 26
|
| |
|
|
| C 1335
|
| S. Tworoger
|
| Vol #:
|
| 26
|
| |
|
|
| C 1336
|
| J. Leavitt
|
| Vol #:
|
| 26
|
| |
|
|
| C 1337
|
| Eligible
|
| Vol #:
|
| 26
|
| |
|
|
| C 1338
|
| T. Drum
|
| Vol #:
|
| 26
|
| |
|
|
| C 1339
|
| C. Johnson
|
| Vol #:
|
| 26
|
| |
|
|
| C 1340
|
| M. Waters
|
| Vol #:
|
| 26
|
| |
|
|
| C 1341
|
| J. Hertz
|
| Vol #:
|
| 26
|
| |
|
|
| C 1342
|
| P. Prichard
|
| Vol #:
|
| 26
|
| |
|
|
| C 1343
|
| M. Erickson
|
| Vol #:
|
| 26
|
| |
|
|
| C 1344
|
| N. Kellogg
|
| Vol #:
|
| 26
|
| |
|
|
| C 1345
|
| L. Floyd
|
| Vol #:
|
| 26
|
| |
|
|
| C 1346
|
| N. Wheeler
|
| Vol #:
|
| 26
|
| |
|
|
| C 1347
|
| V. Short
|
| Vol #:
|
| 26
|
| |
|
|
| C 1348
|
| N. Montanez
|
| Vol #:
|
| 26
|
| |
|
|
| C 1349
|
| D. Galloway
|
| Vol #:
|
| 26
|
| |
|
|
| C 1350
|
| D. Frampton
|
| Vol #:
|
| 26
|
| |
|
|
| EC
6004
|
| Mrs. Sue Milam
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6005
|
| Mrs. Gretchen Morgan
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6006
|
| Visionary Health Compounding Chemist
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6007
|
| none
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6008
|
| Mrs. Kathariene Prosse
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6009
|
| Ob/Gyn NP
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6010
|
| Mrs. Christine Meyers
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6011
|
| Ms. Constance Vieco
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6012
|
| Ms. Debra Hayes
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6013
|
| Ms. Mary Horvath
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6014
|
| Ms. Leanne Garcia
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6015
|
| Ms. Skye Wickland
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6016
|
| Dr. Michelle Violi
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6017
|
| Mrs. Linda Lawson
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6018
|
| Robin Mayfield, P.C.
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6019
|
| Ms. Bonnie Wong
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6020
|
| Miss. Sunayana Mysore
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6021
|
| Ms. Dora Seifert
|
| Vol #:
|
| 24
|
| |
|
|
| EC
6022
|
| Mrs. Pamela Myler
|
| Vol #:
|
| 24
|
|
| | | | | | | | |
| |
|
|
| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
|
| |
|
|
| C
1
Attachment
|
| Ranbaxy Laboratories, Inc. (Ranbaxy)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
| |
|
|
| EMC 2
|
| V. Slone
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 3
|
| C. Baker
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 4
|
| K. Hardesty
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
5
|
| American Meat Institute (AMI)
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0498
|
| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
|
| |
|
|
| C
1
|
| Impax Laboratories, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0004
|
| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0008
|
| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0023
|
| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2006E-0026
|
| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| LET 3
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0035
|
| Patent Extension Application for ZEGERID (omeprazole), U.S. Patent No. 6,489,346
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 2
|
| |
|
|
| 2006E-0040
|
| Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0043
|
| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990
|
| |
|
|
| LET 2
|
| HFD-5 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0089
|
| Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
|
| |
|
|
| ACK 1
|
| HFA-305 to Korein Tillery
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Korein Tillery LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0090
|
| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
|
| |
|
|
| ACK 1
|
| HFA-305 to Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
|
