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| Dockets Entered
On April 19, 2005
Table of Contents
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| Docket #
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| Title
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| 1990N-0165
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| Serving Sizes Food Labeling
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2002E-0342
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| Lea's Shield, U.S. Patent No. 4,703,752
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| 2003E-0247
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| Patent Extension for Campath (Alemtuzumab), 5,545,403
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| 2003E-0249
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| Patent Extension for Elitek (rasburicase) 5,382,518
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| 2003E-0251
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| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
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| 2003E-0257
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| Patent Extension for Neotame, 5,480,668
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| 2003E-0259
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| Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031
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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| 2003P-0279
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| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
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| 2003P-0331
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| ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets (5 mg/400mg; 7.5 mg/400 mg and 10 mg/400 mg)
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| 2003P-0556
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| ANDA for Dihydroergotamine Mesylate Injection
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| 2003V-0185
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| Laser Light Show
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| 2004E-0021
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| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
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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-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| 2004E-0445
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| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0564
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| Agency Information Collection Activities; Proposed Collection;
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0452
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| Regulate the use of coding on food labels
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| 2004Q-0072
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| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| 2005D-0042
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| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings
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| 2005D-0091
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| Guidance for Industry on Waiver of User Fees for Fixed Dose Combination Products and Co-Packaged Products to Treat HIV
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| 2005F-0138
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| provide for the safe use of a mixture of hydrogen peroxide, silver nitrate, phosphoric acid, tartaric acid, glutamic acid, and sodium tripolyphosphate as an antimicrobial agent in bottled drinking wat
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| 2005M-0151
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| P930016/S020 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS), Approved 3/17/05
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| 2005N-0016
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| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005V-0073
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| Laser Light Show
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| 2005V-0086
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| Laser Light Show
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| 2005V-0154
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| Laser Display Device
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| 1990N-0165
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| Serving Sizes Food Labeling
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| ACK 2
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| Helen K. Harris
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| Vol #:
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| 46
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| ACK 3
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| Helen K. Harris
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| Vol #:
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| 47
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
40
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 44
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| SUP
41
Attachment
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 45
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| M
6
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| GCF-1
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| Vol #:
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| 403
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| 2002E-0342
|
| Lea's Shield, U.S. Patent No. 4,703,752
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| |
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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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| 2003E-0247
|
| Patent Extension for Campath (Alemtuzumab), 5,545,403
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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-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
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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-0251
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| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
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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-0257
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| Patent Extension for Neotame, 5,480,668
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| LET
6
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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-0259
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| Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031
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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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| 2003E-0405
|
| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| |
|
|
| LET
5
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| HFD-005 to US Patent & Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2003E-0452
|
| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| |
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| LET
6
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| HFD-005 to US Patent & Trademark Office
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| Vol #:
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| 1
|
|
| | | | | | | | |
|
|
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| 2003P-0279
|
| Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin
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| |
|
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| PDN
1
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| HFD-600 to Jerussi Consulting, Inc
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| Vol #:
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| 1
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| |
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| 2003P-0331
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| ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets (5 mg/400mg; 7.5 mg/400 mg and 10 mg/400 mg)
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| |
|
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| PDN
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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|
| |
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| 2003P-0556
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| ANDA for Dihydroergotamine Mesylate Injection
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| |
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| PDN
1
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| HFD-600 to Hyman, Phelps & McNamara, PC
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| Vol #:
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| 1
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| 2003V-0185
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| Laser Light Show
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| |
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| VRA
2
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| HFZ-300 to Creative Consultants, LLC
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| Vol #:
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| 1
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|
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| 2004E-0021
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| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
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| LET
2
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| HFD-005 to United States Patent & 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
|
| |
|
|
| 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-0389
|
| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2004E-0445
|
| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
|
| |
|
|
| 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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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS
5
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| HFA-305
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| Vol #:
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| 1
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| OR
5
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| HF-3
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| Vol #:
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| 1
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| C 1
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| W. Smith
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| Vol #:
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| 1
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| C 2
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| B. Rogers
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| Vol #:
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| 1
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| C 3
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| H. Freilich
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| Vol #:
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| 1
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| C 4
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| R. Glicker
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| Vol #:
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| 1
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| C 5
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| G. Sardinha
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| Vol #:
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| 1
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| C 6
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| D. Braverman
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| Vol #:
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| 1
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| C 7
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| D. Dean
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| Vol #:
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| 1
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| C 8
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| M. Grosklos
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| Vol #:
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| 1
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| C 9
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| A. Zamora
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| Vol #:
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| 1
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| C 10
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| T. Kaeff
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| Vol #:
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| 1
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| C 11
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| V. Kerlins
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| Vol #:
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| 1
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| C 12
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| A. Hammerschmidit
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| Vol #:
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| 1
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| C 13
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| S. Jaffer
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| Vol #:
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| 1
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| C 14
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| J. West
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| Vol #:
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| 1
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| C 15
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| J.D. Shaneyfelt
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| Vol #:
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| 1
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| C 16
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| S. Prince
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| Vol #:
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| 1
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| C 17
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| D. Griffin
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| Vol #:
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| 1
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| C 18
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| M. Ouiment
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| Vol #:
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| 1
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| C 19
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| B. Ehrlich
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| Vol #:
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| 1
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| EMC 394
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| J.Bonner
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| Vol #:
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| 3
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| EMC 395
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| R. Levine
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| Vol #:
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| 3
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| EMC 396
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| R. Palma-Lulion
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| Vol #:
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| 3
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| EMC 397
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| B. Belmonte
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| Vol #:
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| 3
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| EMC 398
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| E. Sudhalter
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| Vol #:
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| 3
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| EMC 399
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| B. Petit
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| Vol #:
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| 3
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| EMC 400
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| A. Fischer
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| Vol #:
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| 3
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| EMC 401
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| E. Richardson
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| Vol #:
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| 3
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| EMC 402
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| A. Levinson
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| Vol #:
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| 3
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| EMC 403
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| S. McGlon
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| Vol #:
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| 3
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| EMC 404
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| unsign
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| Vol #:
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| 3
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| EMC 405
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| unsign
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| Vol #:
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| 3
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| EMC 406
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| R. Broussard
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| Vol #:
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| 3
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| EMC 407
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| D. Carlson
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| Vol #:
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| 3
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| EMC 408
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| H. Carson
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| Vol #:
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| 3
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| EMC 409
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| J. Barnes
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| Vol #:
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| 3
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| EMC 410
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| R. Coffman
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| Vol #:
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| 3
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| EMC 411
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| S. Stoyke
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| Vol #:
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| 3
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| EMC 412
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| unsign
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| Vol #:
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| 3
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| EMC 413
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| J. Sorenson
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| Vol #:
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| 3
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| EMC 414
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| J. Yang
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| Vol #:
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| 3
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| EMC 415
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| unsign
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| Vol #:
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| 3
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| EMC 416
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| F. Spitale
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| Vol #:
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| 3
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| EMC 417
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| V. Harris
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| Vol #:
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| 3
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| EMC 418
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| unsign
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| Vol #:
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| 3
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| EMC 419
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| J. Nugent
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| Vol #:
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| 3
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| EMC 420
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| M. Cook
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| Vol #:
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| 3
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| EMC 421
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| B. & J. Bergstrom
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| Vol #:
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| 3
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| EMC 422
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| unsign
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| Vol #:
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| 3
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| EMC 423
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| D & M Walsh
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| Vol #:
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| 3
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| EMC 424
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| J. Church
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| Vol #:
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| 3
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| EMC
425
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| Brandt Custom Homes Inc.
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| Vol #:
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| 3
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| EMC 426
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| B. Jimenez
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| Vol #:
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| 3
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| |
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| EMC 427
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| unsign
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| Vol #:
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| 3
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| |
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| EMC 428
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| J. Nusbaum
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| Vol #:
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| 3
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| |
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| EMC 429
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| K. Slick
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| Vol #:
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| 3
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| |
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| EMC 430
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| M& L. Castner
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| Vol #:
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| 3
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| |
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| EMC 431
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| M. Shulman
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| Vol #:
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| 3
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| |
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| EMC 432
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| B. Weil
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| Vol #:
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| 3
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| |
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| EMC 433
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| C. Ramstedt
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| Vol #:
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| 3
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| EMC 434
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| G. Trouski
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| Vol #:
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| 3
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| |
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| EMC 435
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| D. Paul
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| Vol #:
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| 4
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| EMC 436
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| D. Rudy
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| Vol #:
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| 4
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| EMC 437
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| S. Kent
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| Vol #:
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| 4
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| EMC 438
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| D. Corrigan
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| Vol #:
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| 4
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| EMC 439
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| M. Fedorko
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| Vol #:
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| 4
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| EMC 440
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| S.Staten
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| Vol #:
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| 4
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| EMC 441
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| M. Brown
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| Vol #:
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| 4
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| EMC 442
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| M. Baron
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| Vol #:
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| 4
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| EMC 443
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| H. & P. Selkin
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| Vol #:
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| 4
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| EMC 444
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| A. Milstead
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| Vol #:
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| 4
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| EMC 445
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| unsign
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| Vol #:
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| 4
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| EMC 446
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| L. Fein
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| Vol #:
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| 4
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| |
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| EMC 447
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| unsign
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| Vol #:
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| 4
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| EMC 448
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| C. Furnberg
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| Vol #:
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| 4
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| EMC 449
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| K. Freeman
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| Vol #:
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| 4
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| EMC 450
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| P.Wierzbicki
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| Vol #:
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| 4
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| EMC 451
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| P. & S. Swett
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| Vol #:
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| 4
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| |
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| EMC 452
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| S. Huffman
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| Vol #:
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| 4
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| EMC 453
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| C. Wells
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| Vol #:
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| 4
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| EMC 454
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| Jenny
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| Vol #:
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| 4
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| |
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| EMC 455
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| R. Ussher
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| Vol #:
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| 4
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| |
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| EMC 456
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| unsign
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| Vol #:
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| 4
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| |
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| EMC 457
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| J. Runge
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| Vol #:
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| 4
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| EMC 458
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| M. Wedeman
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| Vol #:
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| 4
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| EMC 459
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| B. Jackson
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| Vol #:
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| 4
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| EMC 460
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| L. Murdaugh
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| Vol #:
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| 4
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| |
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| EMC 461
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| unsign
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| Vol #:
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| 4
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| |
|
|
| EMC 462
|
| J. Millican
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 463
|
| S. Kauffman
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 464
|
| S. Lechleiter
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
| |
|
|
| C 16
|
| no signature
|
| Vol #:
|
| 1
|
| |
|
|
| C 17
|
| D. Cotrofeld
|
| Vol #:
|
| 1
|
| |
|
|
| C
18
|
| Dayton Ear,Nose and Throat Surgeons, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
19
|
| Wildegeest Fountain, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C 20
|
| M. and C. Hutton
|
| Vol #:
|
| 1
|
| |
|
|
| C 21
|
| E. Merrill
|
| Vol #:
|
| 1
|
| |
|
|
| C 22
|
| R. Ruiz
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0564
|
| Agency Information Collection Activities; Proposed Collection;
|
| |
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
| |
|
|
| C
12
|
| Ohio Farmers Union
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
| |
|
|
| C 16
|
| K. Zelman, MPH, RD
|
| Vol #:
|
| 5
|
| |
|
|
| 2004P-0452
|
| Regulate the use of coding on food labels
|
| |
|
|
| LET 1
|
| HFS-800 to Bunny Abraham
|
| Vol #:
|
| 1
|
|
| |
|
| 2004Q-0072
|
| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
|
| |
|
|
| PDN
1
|
| HFS-1 to AAC Consulting Group on Behalf of Belovo Inc
|
| Vol #:
|
| 5
|
| |
|
|
| 2005D-0021
|
| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
|
| |
|
|
| C
1
|
| Novartis Pharmaceuticals Corporation (Novartis)
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Genentech
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0022
|
| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
|
| |
|
|
| C
1
|
| Lilly Research Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0030
|
| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
|
|
| | | | | | | | |
|
| |
|
| C
2
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Pharmaceutical research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| NIH Clinical Center
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0042
|
| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings
|
| |
|
|
| C
1
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0091
|
| Guidance for Industry on Waiver of User Fees for Fixed Dose Combination Products and Co-Packaged Products to Treat HIV
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005F-0138
|
| provide for the safe use of a mixture of hydrogen peroxide, silver nitrate, phosphoric acid, tartaric acid, glutamic acid, and sodium tripolyphosphate as an antimicrobial agent in bottled drinking wat
|
|
|
|
|
|
|
|
|
| NFL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005M-0151
|
| P930016/S020 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS), Approved 3/17/05
|
| |
|
|
| AAV
1
|
| VISX, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0016
|
| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
|
|
|
|
|
|
|
|
|
| C
1
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0036
|
| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
|
| |
|
|
| C
2
|
| Novo Nordisk, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| C
4
|
| Scripps Cancer Center Institutional Review Board
|
| Vol #:
|
| 3
|
| |
|
|
| 2005P-0008
|
| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
|
| |
|
|
| C
1
|
| US Federal Trade Commission (FTC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005V-0073
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to William McHugh
|
| Vol #:
|
| 1
|
|
| |
|
| 2005V-0086
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Maple Park Media
|
| Vol #:
|
| 1
|
| |
|
|
| 2005V-0154
|
| Laser Display Device
|
| |
|
|
| ACK
1
|
| HFA-305 to Spectronika LTD.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Spectronika LTD.
|
| Vol #:
|
| 1
|
|
|
