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| Dockets Entered
On November 30, 2004
Table of Contents
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| Docket #
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| Title
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| |
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| |
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| |
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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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| 1998P-0203
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| Eliminate Forced Molting of Laying Birds
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| |
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| 2000N-0504
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| Egg Safety Action Plan
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| 2002P-0244
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| Warning Statement for All HMG Co-A Reductase Inhibitors
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| 2002P-0473
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| ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0410
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| Application User Fees for Combination Products
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0507
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| ANADA for generic hyaluronate sodium injectable solution
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| |
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| 2004P-0512
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| Health Claim Petition for Soluble Fiber from Barley
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| 2004P-0528
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| ANDA suitability for preoperative prep containing a chlorhexidine gluconate (CHG)/isopropol alcohol (IPA) solution with tint
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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|
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| MT
8
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| HFD-560
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| Vol #:
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| 72
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|
|
| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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|
| C
836
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| Weaver Bros., Inc.
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| Vol #:
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| 33
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| C 837
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| J. Charvat
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| Vol #:
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| 33
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| C 838
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| R. Snyder, PhD
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| Vol #:
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| 33
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|
|
| C
839
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| Crystal Farms, Inc.
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| Vol #:
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| 33
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|
|
| C
840
|
| Country Charm Egg Distributors, Inc.
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| Vol #:
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| 33
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| C
841
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| Farm Sanctuary, Inc.
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| Vol #:
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| 33
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| |
|
|
| C
860
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| Weaver Bros., Inc.
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| Vol #:
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| 32
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| |
|
|
| C 861
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| J. Charvat
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| Vol #:
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| 32
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| C
862
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| R. Snyder, PhD
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| Vol #:
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| 32
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| |
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| C
863
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| Country Charm Egg Distributors, Inc.
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| Vol #:
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| 32
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|
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| C
864
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| Crystal Farms, inc.
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| Vol #:
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| 32
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| | | | | | | | |
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|
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| C
865
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| Farm Sanctuary, Inc.
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| Vol #:
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| 32
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| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| LET
14868
|
| North American Pharmacal, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14869
|
| North American Pharmacal, Inc.
|
| Vol #:
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| 131
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| |
|
|
| LET
14870
|
| North American Pharmacal, Inc.
|
| Vol #:
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| 131
|
| |
|
|
| LET
14871
|
| North American Pharmacal, Inc.
|
| Vol #:
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| 131
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| |
|
|
| LET
14872
|
| North American Pharmacal, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14873
|
| North American Pharmacal, Inc.
|
| Vol #:
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| 131
|
| |
|
|
| LET
14874
|
| Oriental Chinese Herbs Pharmaceutical Ltd.
|
| Vol #:
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| 131
|
| |
|
|
| LET
14875
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| Your Vitamins Andrew Lessman
|
| Vol #:
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| 131
|
| |
|
|
| LET
14876
|
| Your Vitamins Andrew Lessman
|
| Vol #:
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| 131
|
| |
|
|
| LET
14877
|
| Fitness Labs Nutrition Corporation
|
| Vol #:
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| 131
|
| |
|
|
| LET
14878
|
| Suarez Corporation Industries
|
| Vol #:
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| 131
|
| |
|
|
| LET
14879
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| Abkit, Inc.
|
| Vol #:
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| 131
|
| |
|
|
| LET
14880
|
| New Sun Nutrition
|
| Vol #:
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| 131
|
| |
|
|
| LET
14881
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14882
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14883
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14884
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14885
|
| Nature's Way Products, Inc.
|
| Vol #:
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| 131
|
| |
|
|
| LET
14886
|
| DBS Labs LLC
|
| Vol #:
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| 131
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| |
|
|
| LET
14887
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| DBS Labs, LLC
|
| Vol #:
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| 131
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| |
|
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| LET
14888
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| DBS Labs LLC
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| Vol #:
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| 131
|
| |
|
|
| LET
14889
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| Nature's Sinshine Products, Inc.
|
| Vol #:
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| 131
|
| |
|
|
| LET
14890
|
| Perrigo Company of South Carolina
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| Vol #:
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| 131
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| |
|
|
| LET
14891
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| Perrigo Company of South Carolina
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| Vol #:
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| 131
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|
| LET
14892
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| Perrigo Company of South Carolina
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| Vol #:
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| 131
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| LET
14893
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| Perrigo Company of South Carolina
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| Vol #:
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| 131
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|
| LET
14894
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| Perrigo Company of South Carlina
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| Vol #:
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| 131
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| |
|
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| LET
14895
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| Perrigo Company of South Carolina
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| Vol #:
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| 131
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| LET
14896
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| Perrigo Company of South Carolina
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| Vol #:
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| 131
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| LET
14897
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| NBTY Inc.
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| Vol #:
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| 131
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| |
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| LET
14898
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| NBTY Inc.
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| Vol #:
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| 131
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| |
|
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| LET
14899
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| NBTY Inc.
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| Vol #:
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| 131
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| |
|
|
| LET
14900
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| NBTY Inc.
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| Vol #:
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| 131
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| |
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| LET
14901
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| NBTY Inc.
|
| Vol #:
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| 131
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|
| | | | | | | | |
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|
|
| LET
14902
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| NBTY Inc.
|
| Vol #:
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| 131
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| |
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| LET
14903
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| NBTY Inc.
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| Vol #:
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| 131
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| |
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|
| LET
14904
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| NBTY Inc.
|
| Vol #:
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| 131
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| |
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|
| LET
14905
|
| NBTY Inc.
|
| Vol #:
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| 131
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| |
|
|
| LET
14906
|
| NBTY Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14907
|
| NBTY Inc.
|
| Vol #:
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| 131
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| |
|
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| LET
14908
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| NBTY Inc.
|
| Vol #:
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| 131
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| |
|
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| LET
14909
|
| NBTY Inc.
|
| Vol #:
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| 131
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| |
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| LET
14910
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| NBTY Inc.
|
| Vol #:
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| 131
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| |
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| LET
14911
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| NBTY Inc.
|
| Vol #:
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| 131
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| LET
14912
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| NBTY Inc.
|
| Vol #:
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| 131
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| LET
14913
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| NBTY Inc.
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| Vol #:
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| 131
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| |
|
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| LET
14914
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| Bee-Alive Inc.
|
| Vol #:
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| 131
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| |
|
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| LET
14915
|
| Tianshi Health Products, Inc.
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14916
|
| Moringa, Inc. dba Zija
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14917
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| Resting in the River, LLC
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14918
|
| Enzymatic Therapy
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14919
|
| Enzymatic Therapy
|
| Vol #:
|
| 131
|
| |
|
|
| LET
14920
|
| Enzymatic Therapy
|
| Vol #:
|
| 131
|
| |
|
|
| 1998P-0203
|
| Eliminate Forced Molting of Laying Birds
|
| |
|
|
| C
1970
|
| Weaver Bros., Inc.
|
| Vol #:
|
| 47
|
| |
|
|
| C 1971
|
| J. Charvat
|
| Vol #:
|
| 47
|
| |
|
|
| C 1972
|
| R. Snyder, PhD
|
| Vol #:
|
| 47
|
| |
|
|
| C
1973
|
| Country Charm Egg Distributors, Inc.
|
| Vol #:
|
| 47
|
| |
|
|
| C
1974
|
| Crystal Farms, Inc.
|
| Vol #:
|
| 47
|
| |
|
|
| C
1975
|
| Farm Sanctuary, Inc.
|
| Vol #:
|
| 47
|
| |
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
| |
|
|
| C
133
|
| Weaver Bros., Inc.
|
| Vol #:
|
| 10
|
| |
|
|
| C 134
|
| J. Charvat
|
| Vol #:
|
| 10
|
| |
|
|
| C 135
|
| R. Snyder, PhD
|
| Vol #:
|
| 10
|
| |
|
|
| C
136
|
| Country Charm Egg Distributors, Inc.
|
| Vol #:
|
| 10
|
| |
|
|
| C
137
|
| Crystal Farms, Inc.
|
| Vol #:
|
| 10
|
| |
|
|
| C
138
|
| Farm Sanctuary, Inc.
|
| Vol #:
|
| 10
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C
2042
|
| American Assn of Pro-Life Obstetricians & Gynecologists (AAPLOG)
|
| Vol #:
|
| 295
|
|
| | | | | | | |
| |
|
|
| C
2043
Signatures
|
| Massachusetts Emergency Contraception Network
|
| Vol #:
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| 295
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| |
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| EMC 11280
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| R. Elliott
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| Vol #:
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| 296
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| EMC 11281
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| A. Cavazos
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| Vol #:
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| 296
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| EMC 11282
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| E. Audo
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| Vol #:
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| 296
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| EMC 11283
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| S. VanGorden
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| Vol #:
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| 296
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| EMC 11284
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| A. Sipiora
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| Vol #:
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| 296
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| EMC 11285
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| H. Weiss
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| Vol #:
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| 296
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| EMC 11286
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| A. Feijoo
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| Vol #:
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| 296
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| EMC 11287
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| K. Dolcini
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| Vol #:
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| 296
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| EMC 11288
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| J. McNally
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| Vol #:
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| 296
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| EMC 11289
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| L. Hackett
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| Vol #:
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| 296
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| EMC 11290
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| N. Shaffer
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| Vol #:
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| 296
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| EMC 11291
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| M. Batchelder
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| Vol #:
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| 296
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| EMC 11292
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| H. Kapolnek
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| Vol #:
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| 296
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| EMC 11293
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| M. Parker
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| Vol #:
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| 296
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| EMC 11294
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| L. Ricks
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| Vol #:
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| 296
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| EMC 11295
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| A. Page
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| Vol #:
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| 296
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| EMC 11296
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| K. Farrow
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| Vol #:
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| 296
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| EMC 11297
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| D. Ruse
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| Vol #:
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| 296
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| EMC 11298
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| K. Fong
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| Vol #:
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| 296
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| EMC 11299
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| J. Brodston
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| Vol #:
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| 296
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| EMC 11300
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| A. Hoskovec
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| Vol #:
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| 296
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| EMC 11301
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| M. Gross
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| Vol #:
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| 296
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| EMC 11302
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| C. Engler
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| Vol #:
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| 296
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| EMC 11303
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| R. Goss
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| Vol #:
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| 296
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| EMC 11304
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| J. Chandler
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| Vol #:
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| 296
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| EMC 11305
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| S. Feeney
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| Vol #:
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| 296
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| EMC 11306
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| G. Reece
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| Vol #:
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| 296
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| EMC 11307
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| M. Essex
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| Vol #:
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| 296
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| EMC 11308
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| M. Essex
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| Vol #:
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| 296
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| EMC 11309
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| G. Reece
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| Vol #:
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| 296
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| EMC 11310
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| T. Vandergraff
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| Vol #:
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| 296
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| EMC 11311
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| J. Nordlund
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| Vol #:
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| 296
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| EMC 11312
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| S. Phillips
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| Vol #:
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| 296
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| EMC 11313
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| A. Hudgens
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| Vol #:
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| 296
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| |
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| EMC 11314
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| A. Cerquone
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| Vol #:
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| 296
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| EMC 11315
|
| C. Jack
|
| Vol #:
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| 296
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| | | | | | | |
| |
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| EMC 11316
|
| S. Pullen
|
| Vol #:
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| 296
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| |
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| EMC 11317
|
| J. Cermele
|
| Vol #:
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| 296
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| |
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| EMC 11318
|
| A. Scherer
|
| Vol #:
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| 296
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| |
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| EMC 11319
|
| R. Reetz
|
| Vol #:
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| 296
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| |
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| EMC 11320
|
| C. Halsey
|
| Vol #:
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| 296
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| |
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| EMC 11321
|
| C. Halsey
|
| Vol #:
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| 296
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| |
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| EMC 11322
|
| K. Okuda
|
| Vol #:
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| 296
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| |
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| EMC 11323
|
| P. Shuffer, MD
|
| Vol #:
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| 296
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| |
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|
| EMC 11324
|
| S. Obleas
|
| Vol #:
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| 296
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| |
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| EMC 11325
|
| A. Bouman
|
| Vol #:
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| 296
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| |
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| EMC 11326
|
| K. Mikuliak
|
| Vol #:
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| 296
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| |
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| EMC 11327
|
| T. Finkbeiner
|
| Vol #:
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| 296
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| |
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| EMC 11328
|
| I. Fosse
|
| Vol #:
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| 296
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| |
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| EMC 11329
|
| S. Perry
|
| Vol #:
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| 296
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| |
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| EMC 11330
|
| C. Elkasim
|
| Vol #:
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| 296
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| |
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| EMC 11331
|
| D. Bohn
|
| Vol #:
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| 296
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| |
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| EMC 11332
|
| J. Martens
|
| Vol #:
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| 296
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| |
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| EMC 11333
|
| A. Montgomery
|
| Vol #:
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| 296
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| |
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| EMC 11334
|
| M. Morris
|
| Vol #:
|
| 296
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| |
|
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| EMC 11335
|
| M. Tertocha
|
| Vol #:
|
| 296
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| |
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| EMC 11336
|
| L. Clancy
|
| Vol #:
|
| 296
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| |
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| EMC 11337
|
| J. Gorman, MD
|
| Vol #:
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| 296
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| |
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| EMC 11338
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| J. Milgram
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| Vol #:
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| 296
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| |
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| EMC 11339
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| D. Kramer
|
| Vol #:
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| 296
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| |
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| EMC 11340
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| B. Johnson
|
| Vol #:
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| 296
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| |
|
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| EMC 11341
|
| T. McClelland
|
| Vol #:
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| 296
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| |
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| EMC 11342
|
| K. Hofsommer
|
| Vol #:
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| 296
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| |
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| EMC 11343
|
| J. Wilson
|
| Vol #:
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| 296
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| |
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| EMC 11344
|
| S. Hoff
|
| Vol #:
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| 296
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| |
|
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| EMC 11345
|
| E. Bear
|
| Vol #:
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| 296
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| |
|
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| EMC 11346
|
| K. Fialko
|
| Vol #:
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| 296
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| |
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| EMC 11347
|
| J. Foss
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11348
|
| M and J Eckenrode
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11349
|
| S. Baker
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11350
|
| A. Jimenez
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11351
|
| E. Ellis
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11352
|
| C. Carlson
|
| Vol #:
|
| 296
|
|
| | | | | | | |
| |
|
|
| EMC 11353
|
| J. Bruenecke
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11354
|
| D. Weinsheimer
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11355
|
| L. Hall
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11356
|
| C. Frye
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11357
|
| D. Noble
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11358
|
| S. Whedon
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11359
|
| S. Scott
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11360
|
| A. Edwards
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11361
|
| A. Belcher
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11362
|
| J. Friedman
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11363
|
| J. Massana
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11364
|
| C. Shelley
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11365
|
| K. Clohessy
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11366
|
| J. Ayala
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11367
|
| M. Szymanski
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11368
|
| N. Rann
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11369
|
| K. Litwak
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11370
|
| K. Hannigan
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11371
|
| D. Bartha
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11372
|
| J. Wright
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11373
|
| S. Benson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11374
|
| T. Perry
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11375
|
| A. Bennett
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11376
|
| S. Rich
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11377
|
| S. Rich
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11378
|
| V. Schroeder
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11379
|
| S. Samoya
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11380
|
| E. Zemlin
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11381
|
| K. Steele
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11382
|
| K. Cooney
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11383
|
| K. Putney
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11384
|
| C. Hart
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11385
|
| K. Noonan
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11386
|
| J. Johnson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11387
|
| R. Fenton
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11388
|
| C. Montgomery
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11389
|
| I. Ellenoben
|
| Vol #:
|
| 296
|
|
| | | | | | | |
| |
|
|
| EMC 11390
|
| E. Herron
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11391
|
| T. Letterman
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11392
|
| A. Farkas
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11393
|
| J. Steil
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11394
|
| N. Watson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11395
|
| D. Kelly
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11396
|
| S. McBryde
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11397
|
| J. Greif
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11398
|
| A. Allred
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11399
|
| J. Hendricks
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11400
|
| J. Miles
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11401
|
| C. Morgenstern
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11402
|
| D. DeLongis
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11403
|
| R. Christ
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11404
|
| A. Whisnant
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11405
|
| E. Kitchens
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11406
|
| C. Creswell
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11407
|
| S. Hericks
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11408
|
| M. Abrego
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11409
|
| K. Bishopric
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11410
|
| J. Khan
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11411
|
| H. Rosenau
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11412
|
| P. DeMiglio
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11413
|
| D. Wiser
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11414
|
| B. Banks
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11415
|
| W. Kear
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11416
|
| A. Feijoo
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11417
|
| E. Zemlin
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11418
|
| K. Fox
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11419
|
| A. Feijoo
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11420
|
| L. Wilson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11421
|
| A. Palmer
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11422
|
| C. Jack
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11423
|
| H. Shuffler
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11424
|
| L. Morris
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11425
|
| N. Gladstein
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11426
|
| J. Mangini
|
| Vol #:
|
| 296
|
|
| | | | | | | | |
| |
|
|
| EMC 11427
|
| N. Kaufman
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11428
|
| M. Weisberger
|
| Vol #:
|
| 296
|
| |
|
|
| 2002D-0018
|
| Race and Ethnicity Data in Clinical Trials for FDA
|
| |
|
|
| C
24
|
| CDISC Submission Data Standards Team
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0244
|
| Warning Statement for All HMG Co-A Reductase Inhibitors
|
| |
|
|
| SUP 1
|
| Dr. J. Whitaker, M.D.
|
| Vol #:
|
| 5
|
| |
|
|
| 2002P-0473
|
| ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
|
| |
|
|
| AMD
2
Attachment 1,
2,
3
|
| Banner Pharmacaps, Inc. (Banner)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0064
|
| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
|
| |
|
|
| C
6
|
| Amphastar Pharmaceuticals, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
| |
|
|
| C
5
|
| King & Spalding, LLP
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| Indiana Medical Device Manufacturers Council (IMDMC)
|
| Vol #:
|
| 1
|
| |
|
|
| C
7
|
| Evangelical Lutheran Good Samaritan Society
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
Bed Safety
Guide
Presentation
|
| Lakeside Consulting
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0410
|
| Application User Fees for Combination Products
|
| |
|
|
| C
1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Combination Product Coalition (CPC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
| |
|
|
| C
2
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Aventis Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Computer Systems Services & Consulting, Inc. (CSSC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
| |
|
|
| C
196
|
| Pacific Biodiesel, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
|
| |
|
|
| C
8
|
| Schering Corporation (Schering Plough)
|
| Vol #:
|
| 4
|
| |
|
|
| 2004P-0507
|
| ANADA for generic hyaluronate sodium injectable solution
|
| |
|
|
| WDL
1
|
| Bioniche Animal Health USA, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0512
|
| Health Claim Petition for Soluble Fiber from Barley
|
| |
|
|
| ACK
1
|
| HFS-830 to National Barley Foods Council
|
| Vol #:
|
| 10
|
|
| | | | | | | | |
| |
|
|
| ACK
2
|
| HFS-830 to National Barley Foods Council
|
| Vol #:
|
| 10
|
| |
|
|
| CP
1
|
| National Barley Foods Council
|
| Vol #:
|
| 1
|
| |
|
|
| CP
2
|
| National Barley Foods Council
|
| Vol #:
|
| 12
|
| |
|
|
| LET
1
|
| HFS-800 to National Barley Foods Council
|
| Vol #:
|
| 10
|
| |
|
|
| SUP
1
Attachments
|
| National Barley Foods Council
|
| Vol #:
|
| 11
|
| |
|
|
| WDL
1
|
| National Barley Foods Council
|
| Vol #:
|
| 10
|
| |
|
|
| 2004P-0528
|
| ANDA suitability for preoperative prep containing a chlorhexidine gluconate (CHG)/isopropol alcohol (IPA) solution with tint
|
| |
|
|
| ACK
1
|
| HFA-305 to Cardinal Health
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Cardinal Health
|
| Vol #:
|
| 1
|
|
|
