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| Dockets Entered
On June 23, 2005
Table of Contents
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| Docket #
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| Title
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| 1977N-0318
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| Penicillin & Tetracycline and all Combinations
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1997V-0231
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| Laser light show
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2002F-0160
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| Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices
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| 2003D-0180
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| Guidance for Industry and the Food and Drug Administration; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile; Availability; Reques
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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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| 2004P-0223
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| Whole Grain Descriptive Claims
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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| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings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-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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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-0227
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| Update on Leukocyte Reduction of Blood and Blood Components; Public Workshop
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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| 1977N-0318
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| Penicillin & Tetracycline and all Combinations
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| ANS
364
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| HFC-20
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| Vol #:
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| 14
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16234
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16235
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16236
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16237
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16238
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16239
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16240
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16241
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16242
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16243
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16244
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| Ortho Molecular Products
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| Vol #:
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| 144
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| 1997V-0231
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| Laser light show
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| EXP 2
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| Paramount Organization, Inc.
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| Vol #:
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| | | | | | | | |
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| C 7487
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| E. Krcic
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| Vol #:
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| 319
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| C 7488
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| R. Sleem
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| Vol #:
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| 319
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| C 7489
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| D. Garces
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| Vol #:
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| 319
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| ANS
54
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| HF-40
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| Vol #:
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| 403
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| C
300
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| State of Utah Department of Agriculture and Food
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| Vol #:
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| 403
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| M
7
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| GCF-1
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| Vol #:
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| 403
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| 2002F-0160
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| Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2003D-0180
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| Guidance for Industry and the Food and Drug Administration; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile; Availability; Reques
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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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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| 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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| EMC 759
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| L. Rose
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| Vol #:
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| 4
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| EMC 760
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| M. Hecker
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| Vol #:
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| 4
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| EMC 761
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| M. Grace
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| Vol #:
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| 4
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| EMC 762
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| M. Grace
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| Vol #:
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| 4
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| EMC 763
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| K. Tehrani
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| Vol #:
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| 4
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| EMC 764
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| D. M. Davis
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| Vol #:
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| 4
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| EMC 765
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| R. Rothman
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| Vol #:
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| 4
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| EMC 766
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| R. Earl
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| Vol #:
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| 4
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| EMC 767
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| L. Hurd
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| Vol #:
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| 4
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| EMC 768
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| A. M. Herling
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| Vol #:
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| 4
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| EMC 769
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| A. Bolowich
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| Vol #:
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| 4
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C 41
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| Number not used
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| Vol #:
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| 4
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| C 42
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| Number not used
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| Vol #:
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| 4
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| EXT
1
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| The Association for Dressing & Sauces
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| Vol #:
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| 4
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| EXT
2
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| Food Products Association
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| Vol #:
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| 4
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| C
17
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| Soyfoods Association of North America (SANA)
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| Vol #:
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| 5
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| C
18
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| Unilever United States, Inc. (Unilever)
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| Vol #:
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| 5
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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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| C
2
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| Public Citizen
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
2
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005E-0259
|
| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| APP
1
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| Gilead Sciences, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2005N-0227
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| Update on Leukocyte Reduction of Blood and Blood Components; Public Workshop
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| NM
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0257
|
| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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| ACK
1
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| HFA-305
to The Weinberg Group Inc.
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| Vol #:
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| 1
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