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| Dockets Entered
On March 13, 2007
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| Docket #
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| Title
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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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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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| 2003E-0243
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| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
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| 2003E-0244
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| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
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| 2003E-0252
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| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2005E-0245
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| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0130
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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| 2007N-0073
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2007P-0093
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| Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
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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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| LET 19385
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19386
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| Flora, Inc.
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| Vol #:
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| 172
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| LET 19387
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| Flora, Inc.
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| Vol #:
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| 172
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| LET 19388
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| Flora, Inc.
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| Vol #:
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| 172
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| LET 19389
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| Flora, Inc.
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| Vol #:
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| 172
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| LET 19390
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| Flora, Inc.
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| Vol #:
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| 172
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| LET 19391
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| DMD Pharmaceuticals
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| Vol #:
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| 172
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| LET 19392
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| Herbal BioDynamics, LLC
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| Vol #:
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| 172
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| LET 19393
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| Bioenergy Life Science, Inc.
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| Vol #:
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| 172
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| LET 19394
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| Bioenergy Life Science, Inc.
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| Vol #:
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| 172
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| LET 19395
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| Doctor's Best, Inc.
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| Vol #:
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| 172
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| LET 19396
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19397
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| | | | | | | | |
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| LET 19398
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19399
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
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| LET 19400
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19401
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19402
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| Indigene Pharmaceuticals, Inc.
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| Vol #:
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| 172
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| LET 19403
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| Indigene Pharmaceuticals, Inc.
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| Vol #:
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| 172
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| LET 19404
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| Indigene Pharmaceuticals, Inc.
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| Vol #:
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| 172
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| LET 19405
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| Indigene Pharmaceuticals, Inc.
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| Vol #:
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| 172
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| LET 19406
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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|
| LET 19407
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
|
|
| LET 19408
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
|
|
| LET 19409
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
|
|
| LET 19410
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
|
|
| LET 19411
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
|
|
| LET 19412
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
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|
| LET 19413
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
|
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| LET 19414
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| FoodScience Corporation
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| Vol #:
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| 172
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|
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| LET 19415
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| Mountain View Labs, LLC
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| Vol #:
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| 172
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| |
|
|
| LET 19416
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| Ellision Enterprise Corp.
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| Vol #:
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| 173
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| |
|
|
| LET 19417
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| Ellision Enterprise Corp.
|
| Vol #:
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| 173
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| |
|
|
| LET 19418
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| Ellision Enterprise Corp.
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| Vol #:
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| 173
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| |
|
|
| LET 19419
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| Ellision Enterprise Corp.
|
| Vol #:
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| 173
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| |
|
|
| LET 19420
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| Ellision Enterprise Corp.
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| Vol #:
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| 173
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|
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| LET 19421
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| Ellision Enterprise Corp.
|
| Vol #:
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| 173
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| |
|
|
| LET 19422
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| Ellision Enterprise Corp.
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| Vol #:
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| 173
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| |
|
|
| LET 19423
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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|
| LET 19424
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| Botanical Laboratories, Inc.
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| Vol #:
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| 173
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| LET 19425
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| Botanical Laboratories, Inc.
|
| Vol #:
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| 173
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| |
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|
| LET 19426
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 173
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| |
|
|
| 2003D-0044
|
| Reporting Results for Studies Evaluating Diagnostic Tests
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| |
|
|
| GDL 2
|
| Guidance
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| Vol #:
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| 1
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| |
|
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| NAD 2
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0243
|
| Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
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| |
|
|
| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2003E-0244
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| Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
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|
| | | | | | | | |
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| |
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2003E-0252
|
| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
| |
|
| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| |
|
|
| LET 8
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| |
|
|
| NAL 1
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| FDA
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| Vol #:
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| 6
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| SS 1
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| Supporting Statement
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| Vol #:
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| 6
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|
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| 2005E-0245
|
| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| |
|
|
| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| |
|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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|
| EC 1711
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| Mrs. Marjorie Swanson
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| Vol #:
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| 31
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| EC 1712
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| Ms. Lesa Newmaster
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| Vol #:
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| 31
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| EC 1713
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| Mrs. Donna Ford
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| Vol #:
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| 31
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| EC 1714
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| lindgren & smith inc
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| Vol #:
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| 31
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| EC 1715
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| Mrs. Catherine Dempsey
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| Vol #:
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| 31
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| EC 1716
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| Celiac.com
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| Vol #:
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| 31
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| EC 1717
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| Mr. Joseph Hooper
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| Vol #:
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| 31
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| EC 1718
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| Mrs. Maribeth Weirich
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| Vol #:
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| 31
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| EC 1719
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| Mr. arthur bloom
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| Vol #:
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| 31
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| EC 1720
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| Ms. Leslie Foy
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| Vol #:
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| 31
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| EC 1721
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| Mrs. Faye Wisen
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| Vol #:
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| 31
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| EC 1722
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| Mrs. Diane Minner
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| Vol #:
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| 31
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| EC 1723
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| Mr. pasquale baccarella
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| Vol #:
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| 31
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| EC 1724
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| Miss. Colleen McGuire
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| Vol #:
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| 31
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| EC 1725
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| Mrs. Catherine Lawson
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| Vol #:
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| 31
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| EC 1726
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| Ms. Jennifer Holden
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| Vol #:
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| 31
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| EC 1727
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| Ms. Mary Schlomann
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| Vol #:
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| 31
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| EC 1728
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| Universidad Central del Caribe SOM
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| Vol #:
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| 31
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| EC 1729
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| Ms. Gwyneth Cravens
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| Vol #:
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| 31
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| EC 1730
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| Ms. Kara T. McAlister
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| Vol #:
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| 31
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| EC 1731
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| Mrs. Amy Warner Koch
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| Vol #:
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| 31
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| EC 1732
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| Ms. Valerie Davenport
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| Vol #:
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| 31
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| EC 1733
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| Fine Arts Work Center
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| Vol #:
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| 31
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| EC 1734
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| Mr. Michael Garrett
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| Vol #:
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| 31
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| EC 1735
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| KnoxCeliacs
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| Vol #:
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| 31
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| EC 1736
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| Mrs. sheryl mchaffie
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| Vol #:
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| 31
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| EC 1737
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| Ms. Linda Roper
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| Vol #:
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| 31
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| EC 1738
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| Mrs. Lorna Horishny
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| Vol #:
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| 31
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| EC 1739
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| Mr. Kelly Vogt
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| Vol #:
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| 31
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| EC 1740
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| Mr. Lou Solton
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| Vol #:
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| 31
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| EC 1741
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| Mr. Phillip Croom
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| Vol #:
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| 31
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| EC 1742
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| Ms. Colleayn Klaibourne
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| Vol #:
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| 31
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| EC 1743
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| Ms. Margaret Romanowski
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| Vol #:
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| 31
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| EC 1744
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| Mrs. Sandra Kagan
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| Vol #:
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| 31
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| EC 1745
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| Mrs. Sandra Kagan
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| Vol #:
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| 31
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| EC 1746
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| self
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| Vol #:
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| 31
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| EC 1747
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| Miss. Jamie Bender
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| Vol #:
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| 31
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| EC 1748
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| Mrs. Katheen Ueland
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| Vol #:
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| 31
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| EC 1749
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| Dr. Ritva Keski-Kuha
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| Vol #:
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| 31
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| EC 1750
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| Ms. Kelley Regan
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| Vol #:
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| 31
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| EC 1751
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| Mrs. Beverly Jaquith
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| Vol #:
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| 31
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| EC 1752
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| Mrs. Elizabeth Muller
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| Vol #:
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| 31
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| EC 1753
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| Ms. Cheri Williams
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| Vol #:
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| 31
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|
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| EC 1754
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| Mrs. Lisa VanderZwaag
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| Vol #:
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| 31
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| EC 1755
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| Mrs. Camrynne Six
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| Vol #:
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| 31
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| |
|
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| EC 1756
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| Mrs. Joyce Peters
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| Vol #:
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| 31
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| |
|
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| EC 1757
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| Mrs. Diane Holmes
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| Vol #:
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| 31
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| |
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| EC 1758
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| Mr. Moses Gingerich
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| Vol #:
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| 31
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| |
|
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| EC 1759
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| Ms. Susan Bigras
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| Vol #:
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| 31
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| |
|
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| EC 1760
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| Mrs. ellen darlene brock
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| Vol #:
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| 31
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| |
|
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| EC 1761
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| Mr. Dale Hughes
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| Vol #:
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| 31
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| |
|
|
| EC 1762
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| Mr. James Schinnerer
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| Vol #:
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| 31
|
| |
|
|
| EC 1763
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| Mr. Walter Miller
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| Vol #:
|
| 31
|
| |
|
|
| EC 1764
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| Mr. Robert Weber
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1765
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| Mrs. Regina Carelli
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| Vol #:
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| 31
|
| |
|
|
| EC 1766
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| Mrs. Betty Michaels
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1767
|
| Mrs. Kimberly Kaercher
|
| Vol #:
|
| 31
|
|
| | | | | | | |
|
| |
|
| EC 1768
|
| Ms. Sheila Wijfjes
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1769
|
| Mrs. Patricia Clements
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1770
|
| Ms. Deborah Blair
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1771
|
| Mrs. Lorraine Fox
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1772
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| none
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1773
|
| Mrs. Annmarie Imbrosciano
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1774
|
| Ms. K Shuey
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1775
|
| GIG Asheville, N.C.
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1776
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| Individual
|
| Vol #:
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| 31
|
| |
|
|
| EC 1777
|
| Miss. Rachel Cunningham
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1778
|
| Mrs. rita kaminski
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1779
|
| Mrs. Karen Tyson
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1780
|
| Ms. Deborah Benyahia
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1781
|
| Ms. Dana Wilson
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1782
|
| Mrs. joanie riddle
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1783
|
| None
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1784
|
| Mrs. Susan Hruza
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1785
|
| Mr. Robert LaDue
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1786
|
| Mr. Craig Deep
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1787
|
| Ms. Amy Goldin
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1788
|
| Dr. alan frank
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1789
|
| Mr. Greg Teague
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1790
|
| Mrs. Susan McConville
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1791
|
| Mrs. Amy Lynn Criger
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1792
|
| Dr. Douglas Corley
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1793
|
| Ms. Sarah Tacy
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1794
|
| Mrs. Leigh Banducci
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1795
|
| Ms. Serena Castelli
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1796
|
| Mrs. Treva Bauer
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1797
|
| Dr. James Markusic
|
| Vol #:
|
| 31
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| |
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| EC 1798
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| Mrs. Ruth Pulskamp
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| Vol #:
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| 31
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| |
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| EC 1799
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| Mrs. Karen Dungan
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| Vol #:
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| 31
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| |
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| EC 1800
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| Mr. Dave Baird
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| Vol #:
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| 31
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| |
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| EC 1801
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| Mr. Jeff Brinkley
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| Vol #:
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| 31
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| |
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| EC 1802
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| Dr. Ann Brown
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| Vol #:
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| 31
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| |
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| EC 1803
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| Mr. Louis Ferriol
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| Vol #:
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| 31
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| |
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| EC 1804
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| Dr. Lucy Collins
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| Vol #:
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| 31
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| | | | | | | | |
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| |
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| EC 1805
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| Mrs. Jenica Sjoberg
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| Vol #:
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| 31
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| |
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| EC 1806
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| Mrs. Mary Paolazzi
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| Vol #:
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| 31
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| |
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| EC 1807
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| Mrs. Patricia Landreth
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| Vol #:
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| 31
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| |
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| EC 1808
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| Mrs. Leigh Ann Ralsten
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| Vol #:
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| 31
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| |
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| EC 1809
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| Mrs. Anne Morais
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| Vol #:
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| 31
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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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| |
|
|
| C 18273
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| G. Spivey
|
| Vol #:
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| 198
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| |
|
|
| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| |
|
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| |
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| |
|
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| REF 1
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| Reference
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| Vol #:
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| 2
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| |
|
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| |
|
|
| C 12
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| KS&A Knowledge Support & Action
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| Vol #:
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| 1
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|
| |
|
| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| |
|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
|
|
| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| |
|
|
| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
|
|
| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| |
|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2006N-0061
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| Charging for Investigational Drugs
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| |
|
|
| C 7
|
| K Bolick
|
| Vol #:
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| 1
|
| |
|
|
| EC 5
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| Pfizer
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| Vol #:
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| 1
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| |
|
|
| EC 6
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| Ms. Irina Auerbuch
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| Vol #:
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| 1
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| |
|
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| EC 7
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| Ms. Ruby Hayes
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| Vol #:
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| 1
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| |
|
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| EC 8
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| Ms. Diane MacKinnon
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| Vol #:
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| 1
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| |
|
|
| EC 9
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| Patients Against Lymphoma
|
| Vol #:
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| 1
|
| |
|
|
| EC 10
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| Breast Cancer Action
|
| Vol #:
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| 1
|
| |
|
|
| EC 11
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| America's Health Insurance Plans
|
| Vol #:
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| 1
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| |
|
|
| EXT 2
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| Pendergast Consulting
|
| Vol #:
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| 1
|
| |
|
|
| M 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
| |
|
|
| C 9
|
| O Kistler
|
| Vol #:
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| 1
|
|
| | | | | | | |
|
| |
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| C 10
|
| Applied Cutting Technology Inc
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| Vol #:
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| 1
|
| |
|
|
| C 11
|
| E Damaser PhD
|
| Vol #:
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| 1
|
| |
|
|
| C 12
|
| K Bolick
|
| Vol #:
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| 1
|
| |
|
|
| C 13
|
| D Looney
|
| Vol #:
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| 1
|
| |
|
|
| EC 15
|
| The Life Raft Group
|
| Vol #:
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| 1
|
| |
|
|
| EC 16
|
| The Annie Appleseed Project
|
| Vol #:
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| 1
|
| |
|
|
| EC 17
|
| The Alliance Against Exceptionally Rare Diseases
|
| Vol #:
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| 1
|
| |
|
|
| EC 18
|
| Mr. Raymond Campbell
|
| Vol #:
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| 1
|
| |
|
|
| EC 19
|
| Patients Against Lymphoma
|
| Vol #:
|
| 1
|
| |
|
|
| EC 20
|
| Mrs. nancy ledonne
|
| Vol #:
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| 1
|
| |
|
|
| EC 21
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| Family of Patient
|
| Vol #:
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| 1
|
| |
|
|
| EC 22
|
| Mr. Donald Kenney
|
| Vol #:
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| 1
|
| |
|
|
| EC 23
|
| Mrs. Nita Bradford
|
| Vol #:
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| 1
|
| |
|
|
| EC 24
|
| Mr. John Doran
|
| Vol #:
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| 1
|
| |
|
|
| EC 25
|
| Mr. William D. Doran, Colonel, USAF
|
| Vol #:
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| 1
|
| |
|
|
| EC 26
|
| Dr. margaret hagan
|
| Vol #:
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| 1
|
| |
|
|
| EC 27
|
| Huntington's Disease Drug Works.
|
| Vol #:
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| 1
|
| |
|
|
| EC 28
|
| National Association of Epilepsy Centers (NAEC)
|
| Vol #:
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| 1
|
| |
|
|
| EC 29
|
| America's Health Insurance Plans
|
| Vol #:
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| 1
|
| |
|
|
| EC 30
|
| Ms. Judy Werth
|
| Vol #:
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| 1
|
| |
|
|
| EC 31
|
| Ms. Judy Werth
|
| Vol #:
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| 1
|
| |
|
|
| EC 32
|
| Mr. Jeff Bennett
|
| Vol #:
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| 1
|
| |
|
|
| EC 33
|
| Marti Nelson Cancer Foundation
|
| Vol #:
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| 1
|
| |
|
|
| EC 34
|
| Mr. Walter C. Sterling,Jr.
|
| Vol #:
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| 1
|
| |
|
|
| EC 35
|
| Mr. Gregory Brown
|
| Vol #:
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| 1
|
| |
|
|
| EC 36
|
| Ms. Scott Graffius
|
| Vol #:
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| 1
|
| |
|
|
| EC 37
|
| Ms. Carolyn Williams
|
| Vol #:
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| 1
|
| |
|
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| EC 38
|
| Mr. d. greenberg
|
| Vol #:
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| 1
|
| |
|
|
| EC 39
|
| Mrs. carla Gamradt
|
| Vol #:
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| 1
|
| |
|
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| EC 40
|
| Mrs. Gail Larsen
|
| Vol #:
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| 1
|
| |
|
|
| EC 41
|
| Mr. John Strongitharm
|
| Vol #:
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| 1
|
| |
|
|
| EC 42
|
| Mr. Mitch Peterson
|
| Vol #:
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| 1
|
| |
|
|
| EC 43
|
| Mrs. Barbara Everhart
|
| Vol #:
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| 1
|
| |
|
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| EC 44
|
| Mr. Robert Everhart
|
| Vol #:
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| 1
|
| |
|
|
| EC 45
|
| Mr. Erik Roadfeldt
|
| Vol #:
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| 1
|
| |
|
|
| EC 46
|
| Ms. Jennifer Lynch
|
| Vol #:
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| 1
|
| |
|
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| EC 47
|
| Novo Nordisk Inc.
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
| |
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| EC 48
|
| Hemophilia Association of the Capital Area
|
| Vol #:
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| 1
|
| |
|
|
| EC 49
|
| Forum for Collaborative HIV Research
|
| Vol #:
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| 1
|
| |
|
|
| EC 50
|
| Ms. Donna Spear
|
| Vol #:
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| 1
|
| |
|
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| EC 51
|
| Mr. Tomas Owen
|
| Vol #:
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| 1
|
| |
|
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| EC 52
|
| Mr. Charles LaFleur
|
| Vol #:
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| 1
|
| |
|
|
| EC 53
|
| Eli Lilly
|
| Vol #:
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| 1
|
| |
|
|
| EC 54
|
| Ms. Beverly Hill
|
| Vol #:
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| 1
|
| |
|
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| EC 55
|
| Mr. bob mills
|
| Vol #:
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| 1
|
| |
|
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| EC 56
|
| Mrs. Kathy Mills
|
| Vol #:
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| 1
|
| |
|
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| EC 57
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| Ovarian Cancer National Alliance
|
| Vol #:
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| 1
|
| |
|
|
| EC 58
|
| Mr. Dylan Mills
|
| Vol #:
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| 1
|
| |
|
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| EC 59
|
| Mr. Jarry Keppers
|
| Vol #:
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| 1
|
| |
|
|
| EXT 2
|
| Pendergast Consulting
|
| Vol #:
|
| 1
|
| |
|
|
| M 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0130
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0073
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0093
|
| Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
|
| |
|
|
| ACK 1
|
| FDA/DDM to Perdue Pharma L.P.
|
| Vol #:
|
| 1
|
| |
|
|
| ACK 2
|
| Number Not Used
|
| Vol #:
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| 1
|
| |
|
|
| CP 1
|
| Perdue Pharma L.P.
|
| Vol #:
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| 1
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|
|
