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| Dockets Entered
On November 24, 2003
Table of Contents
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| Docket #
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| Title
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| 1981N-0033P
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| Antiplaque & Antiplaque-Related Claims
|
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2000E-1403
|
| Patent Extension Prevnair, No. 5,360,897
|
|
|
| 2000E-1404
|
| Patent Extension Levulan Kerastick, No. 5,079,262
|
|
|
| 2001E-0030
|
| Patent Extension for TEQUIN, No. 4,980,470
|
|
|
| 2001E-0031
|
| Patent Extension for EXELON, No. 4,948,807
|
|
|
| 2001E-0098
|
| TNKase, Patent Extension Application No.5,385,732
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|
|
| 2001E-0225
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| Patent Term Extension Application, CANCIDAS No. 5,514,650
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|
|
| 2001E-0367
|
| Patent Term Extension Application, STARLIX No. 34,878
|
|
|
| 2001E-0403
|
| Patent Term Extension Application; Valcyte No. 6,083,953
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|
|
| 2001E-0419
|
| Patent Term Extension Application, Precedex No. 4,910,214
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|
|
| 2002E-0020
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| Patent Term Application for Zometa No. 4,939,130
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|
|
| 2002E-0021
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| Patent Term Application for Hyperion LTK Sys. No. 4,976,709
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|
|
| 2002E-0064
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| Patent Extension Application for Tracleer, No. 5,292,740
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|
|
| 2002E-0147
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| Patent Extension 5,258,494, OP-1 Implant
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|
|
| 2002E-0150
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| Gynecare Intergel, U.S. Patent Extension No. 5,532,221
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|
|
| 2002E-0343
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| Patent Term Application for Zevalin No. 5,776,456
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|
|
| 2002E-0345
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| Patent Term Application for Aromanis No. 4,808,616
|
|
|
| 2002N-0209
|
| Governing First Amendment Case Law
|
|
|
| 2002P-0406
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| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
|
|
| 2002V-0415
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| LAD-01 Medical Laser Product
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|
|
| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
| 2003E-0030
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| Patent Term Extension Application for FASLODEX No. 4,659,516
|
|
|
| 2003E-0031
|
| Patent Extension Application for VFEND No. 5,567,817
|
|
|
| 2003E-0032
|
| Patent Term Extension Application for IMAGENT, No. 5,639,443
|
|
|
| 2003E-0035
|
| Patent Term Extension Application for ZETIA No. RE37,721
|
|
|
| 2003E-0247
|
| Patent Extension for Campath (Alemtuzumab), 5,545,403
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
| 2003E-0251
|
| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
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|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
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|
|
| 2003E-0260
|
| Patent Extension for Amevive (alefacept), 5,547,853
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|
|
| 2003E-0405
|
| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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|
|
| 2003E-0406
|
| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
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|
|
| 2003E-0411
|
| Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
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|
|
| 2003E-0416
|
| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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|
|
| 2003E-0418
|
| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
|
|
|
| 2003E-0419
|
| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
|
|
| | | | | | | | |
|
|
| 2003E-0448
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
|
|
|
| 2003E-0449
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
|
|
|
| 2003E-0452
|
| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
|
|
|
| 2003E-0458
|
| Patent Extension, Velcade, bortezomib, #5,780,454
|
|
|
| 2003M-0532
|
| Premarket Approval P000028 - AFFINITY Cage System
|
|
|
| 2003M-0533
|
| P990027/S006 - Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction
|
|
|
| 2003M-0536
|
| HDE Number: H020003, CONTEGRA Pulmonary Valved Conduit
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
| 2003P-0300
|
| Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons
|
|
|
| 1981N-0033P
|
| Antiplaque & Antiplaque-Related Claims
|
|
| C 12
|
| Ciba Speciality Chemicals Corporation (Ciba)
|
| Vol #:
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| 19
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
11559
|
| Neways International
|
| Vol #:
|
| 91
|
|
|
| LET
11560
|
| SmartScience Laboratories, Inc.
|
| Vol #:
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| 91
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|
|
| LET
11561
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 91
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|
|
| LET
11562
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| Reliance Vitamin Company, Inc.
|
| Vol #:
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| 91
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|
|
| LET
11563
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| Nutriment Innovations Inc.
|
| Vol #:
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| 91
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|
|
| LET
11564
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| Traditional Medicinals, Inc.
|
| Vol #:
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| 91
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|
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| LET
11565
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| E'Ola International
|
| Vol #:
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| 91
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|
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| LET
11566
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| Bio-Genics, Inc.
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| Vol #:
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| 91
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|
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| LET
11567
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| Bio-Genics, Inc.
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| Vol #:
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| 91
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|
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| LET
11568
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| Market America, Inc.
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| Vol #:
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| 91
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|
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| LET
11569
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| Naturade Inc.
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| Vol #:
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| 91
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|
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| LET
11570
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| Naturade Inc.
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| Vol #:
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| 91
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|
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| LET
11571
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| Naturade Inc.
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| Vol #:
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| 91
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|
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| LET
11572
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| Naturade, Inc.
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| Vol #:
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| 91
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|
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| LET
11573
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| Food Science of Vermont
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| Vol #:
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| 91
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|
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| LET
11574
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| Hansen's Natural
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| Vol #:
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| 91
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|
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| LET
11575
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 91
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|
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| LET
11576
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 91
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| | | | | | | | |
|
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| LET
11577
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 91
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|
|
| LET
11578
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 91
|
|
|
| LET
11579
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| Phyto Pharmica Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11580
|
| Phyto Pharmica Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11581
|
| Phyto Pharmica Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11582
|
| Synergy Worldwide
|
| Vol #:
|
| 91
|
|
|
| LET
11583
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11584
|
| Nature's Sunshine Products,Inc.
|
| Vol #:
|
| 91
|
|
|
| LET
11585
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11586
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11587
|
| Source Naturals
|
| Vol #:
|
| 91
|
|
|
| LET
11588
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 91
|
|
|
| LET
11589
|
| Your Vitamins
|
| Vol #:
|
| 91
|
|
|
| 2000E-1403
|
| Patent Extension Prevnair, No. 5,360,897
|
|
|
| LET
7
|
| HFD-5 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2000E-1404
|
| Patent Extension Levulan Kerastick, No. 5,079,262
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0030
|
| Patent Extension for TEQUIN, No. 4,980,470
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0031
|
| Patent Extension for EXELON, No. 4,948,807
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0098
|
| TNKase, Patent Extension Application No.5,385,732
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0225
|
| Patent Term Extension Application, CANCIDAS No. 5,514,650
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0367
|
| Patent Term Extension Application, STARLIX No. 34,878
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0403
|
| Patent Term Extension Application; Valcyte No. 6,083,953
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2001E-0419
|
| Patent Term Extension Application, Precedex No. 4,910,214
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2002E-0020
|
| Patent Term Application for Zometa No. 4,939,130
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0021
|
| Patent Term Application for Hyperion LTK Sys. No. 4,976,709
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0064
|
| Patent Extension Application for Tracleer, No. 5,292,740
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0147
|
| Patent Extension 5,258,494, OP-1 Implant
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0150
|
| Gynecare Intergel, U.S. Patent Extension No. 5,532,221
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0343
|
| Patent Term Application for Zevalin No. 5,776,456
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0345
|
| Patent Term Application for Aromanis No. 4,808,616
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2002N-0209
|
| Governing First Amendment Case Law
|
|
|
| C
112
|
| Citrus Grower Associates, Inc. (CGA)
|
| Vol #:
|
| 26
|
|
|
| 2002P-0406
|
| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
|
|
| C
2
|
| The Weinberg Group, Inc.
|
| Vol #:
|
| 2
|
|
|
| 2002V-0415
|
| LAD-01 Medical Laser Product
|
|
|
| SUP
1
Tab 2,
3
|
| Norwood Abbey Ltd
|
| Vol #:
|
| 1
|
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
| EXT
1
|
| Branded Pharmaceutical Assn (BPA)
|
| Vol #:
|
| 1
|
|
|
| 2003E-0030
|
| Patent Term Extension Application for FASLODEX No. 4,659,516
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0031
|
| Patent Extension Application for VFEND No. 5,567,817
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0032
|
| Patent Term Extension Application for IMAGENT, No. 5,639,443
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0035
|
| Patent Term Extension Application for ZETIA No. RE37,721
|
|
| | | | | | | | |
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0247
|
| Patent Extension for Campath (Alemtuzumab), 5,545,403
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0251
|
| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0260
|
| Patent Extension for Amevive (alefacept), 5,547,853
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark
Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0405
|
| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0406
|
| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0411
|
| Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0416
|
| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0418
|
| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0419
|
| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0448
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0449
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0452
|
| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
|
|
| | | | | | | | |
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0458
|
| Patent Extension, Velcade, bortezomib, #5,780,454
|
|
|
| LET
2
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003M-0532
|
| Premarket Approval P000028 - AFFINITY Cage System
|
|
|
| AAV 1
|
| Medtronic Sofamor Danek
|
| Vol #:
|
| 1
|
|
|
| 2003M-0533
|
| P990027/S006 - Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction
|
|
|
| AAV
1
Approval
Order, SSED, Labeling
|
| Bausch & Lomb, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003M-0536
|
| HDE Number: H020003, CONTEGRA Pulmonary Valved Conduit
|
|
|
| AAV
1
Approval
Order, SSED, Labeling
|
| Medtronic, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| C
6
|
| South Dakota Department of Agriculture
|
| Vol #:
|
| 1
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
| C
8
|
| National Restaurant Assn
|
| Vol #:
|
| 6
|
|
|
| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
|
|
| C
1
Tab
1, 2, 3, 4
|
| Catalina Health Resource (CHR)
|
| Vol #:
|
| 2
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| C
40
|
| University of Maryland
|
| Vol #:
|
| 5
|
|
|
| C
41
|
| Pfizer, Inc. (Pfizer)
|
| Vol #:
|
| 5
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| C 15
|
| Jill M. Korsmo
|
| Vol #:
|
| 3
|
|
|
| C
16
|
| Honorable Dan Burton
|
| Vol #:
|
| 3
|
|
|
| C 17
|
| Janet Girard
|
| Vol #:
|
| 3
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
| C 42
|
| Barbara Bear
|
| Vol #:
|
| 6
|
|
|
| 2003P-0300
|
| Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons
|
|
|
| LET
1
|
| HFD-007 to The Weinberg Group, Inc.
|
| Vol #:
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| 1
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