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| Dockets Entered
On June 8, 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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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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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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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007P-0224
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| ANDA Suitability Petition for NDA 21-774 Ambien CR (Zolpidem tartrate)
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| 2007P-0226
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| to permit an ANDA suitability for Donepezil Hydrochloride Orally Dissolving Film Stripps, 5 mg and 10 mg
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19920
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| Enzyme Therapy, Inc.
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| Vol #:
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| 175
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| LET 19921
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| Enzyme Therapy, Inc.
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| Vol #:
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| 175
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| LET 19922
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19923
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19924
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19925
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19926
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| Alltech, Inc.
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| Vol #:
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| 175
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| LET 19927
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19928
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19929
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19930
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19931
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19932
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19933
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19934
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19935
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19936
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19937
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19938
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19939
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19940
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19941
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19942
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19943
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19944
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19945
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| Eu Yan Sang (Hong Kong) Limited
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| Vol #:
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| 175
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| LET 19946
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| Univera LifeSciences, Inc.
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| Vol #:
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| 175
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| LET 19947
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| Source Naturals
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| Vol #:
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| 175
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| LET 19948
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| Source Naturals
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| Vol #:
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| 175
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| LET 19949
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19950
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19951
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19952
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19953
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| Phytosolution Nutraceutical Systems llc
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| Vol #:
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| 175
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| LET 19954
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| Phytosolution Nutraceutical Systems llc
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| Vol #:
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| 175
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| LET 19955
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| Phytosolution Nutraceutical Systems llc
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| Vol #:
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| 175
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| LET 19956
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| Phytosolution Nutraceutical Systems llc
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| Vol #:
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| 175
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| LET 19957
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| Phytosolution Nutraceutical Systems llc
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| Vol #:
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| 175
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| LET 19958
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| Taisho Pharmaceutical CA, Inc.
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| Vol #:
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| 175
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| LET 19959
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| Eu Yan Sang (Hong Kong) Limited
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| Vol #:
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| 175
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| LET 19960
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19961
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19962
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19963
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19964
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19965
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19966
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| HERB PHARM
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| Vol #:
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| 175
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| LET 19967
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| AdvoCare
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| Vol #:
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| 175
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| LET 19968
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| Sante' Active, Inc.
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| Vol #:
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| 175
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| LET 19969
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| EQUAVIE
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| Vol #:
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| 175
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| LET 19970
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| EQUAVIE
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| Vol #:
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| 175
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| LET 19971
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| EQUAVIE
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| Vol #:
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| 175
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| LET 19972
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| EQUAVIE
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| Vol #:
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| 175
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| LET 19973
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| EQUAVIE
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| Vol #:
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| 175
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| LET 19974
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| EQUAVIE
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| Vol #:
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| 175
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| LET 19975
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| Chenko Inc.
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| Vol #:
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| 175
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| LET 19976
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| NBTY
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| Vol #:
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| 175
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| LET 19977
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| NBTY
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| Vol #:
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| 175
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| LET 19978
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| Pure Encapsulations
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| Vol #:
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| 175
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| LET 19979
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| Source Naturals
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| Vol #:
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| 175
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| LET 19980
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| Taisho Pharmaceutical CA, Inc.
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| Vol #:
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| 175
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| LET 19981
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| Orenda Internatyional, LLC
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| Vol #:
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| 175
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| LET 19982
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| CardioTabs, Inc.
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| Vol #:
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| 175
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| LET 19983
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| Orenda International, LLC
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| Vol #:
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| 175
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| LET 19984
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| ChildLife
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| Vol #:
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| 175
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| LET 19985
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| Pfantastic Medical Research Institute, LLC
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| Vol #:
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| 175
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| LET 19986
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19987
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19988
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19989
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19990
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19991
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19992
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| Boots Retail USA Inc.
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| Vol #:
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| 175
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| LET 19993
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| Enzymatic Therapy Inc.
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| Vol #:
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| 175
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| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
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| C 1334
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| J. Ungar
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| Vol #:
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| 68
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| C 1335
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| P. Crane
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| Vol #:
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| 68
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| C 1336
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| N. Gordon
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| Vol #:
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| 68
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| C 1337
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| R. Garcia
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| Vol #:
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| 68
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| C 1338
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| L. Graham
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| Vol #:
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| 68
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| C 1339
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| B. Wardle
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| Vol #:
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| 68
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| C 1340
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| T. Christon
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| Vol #:
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| 68
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| C 1341
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| C. Camp
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| Vol #:
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| 68
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| C 1342
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| S. Mehrotra
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| Vol #:
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| 68
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| C 1343
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| M. Wade
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| Vol #:
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| 68
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| C 1344
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| P. Stone
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| Vol #:
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| 68
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| C 1345
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| M. Guenther
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| Vol #:
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| 68
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| C 1346
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| M. Lovato
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| Vol #:
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| 68
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| C 1347
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| J. Julien
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| Vol #:
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| 68
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| C 1348
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| J. Halloran
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| Vol #:
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| 68
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| C 1349
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| J. Tessmer
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| Vol #:
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| 68
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| C 1350
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| L. Wikstrom
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| Vol #:
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| 68
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| C 1351
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| E. Smith
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| Vol #:
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| 68
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| C 1352
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| T. Peralta
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| Vol #:
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| 68
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| C 1353
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| S. McDonald
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| Vol #:
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| 68
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| C 1354
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| M. Converse
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| Vol #:
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| 68
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| C 1355
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| M. Ventrella
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| Vol #:
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| 68
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| C 1356
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| K. Grag
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| Vol #:
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| 68
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| C 1357
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| M. Steele
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| Vol #:
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| 68
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| C 1358
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| J. Otto
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| Vol #:
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| 68
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| C 1359
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| M. Shanahan
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| Vol #:
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| 68
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| C 1360
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| N. Polsue
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| Vol #:
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| 68
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| C 1361
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| M. Genoa
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| Vol #:
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| 68
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| C 1362
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| S. Camp
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| Vol #:
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| 68
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| C 1363
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| K. Oda
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| Vol #:
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| 68
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| C 1364
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| L. Pucci
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| Vol #:
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| 68
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| C 1365
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| C. Thiel
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| Vol #:
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| 68
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| C 1366
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| V. Fong
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| Vol #:
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| 68
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| C 1367
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| S. McNamara
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| Vol #:
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| 68
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| C 1368
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| M. Bronsnan
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| Vol #:
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| 68
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| C 1369
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| T. Barney
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| Vol #:
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| 68
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| C 1370
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| T. Schuster
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| Vol #:
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| 68
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| C 1371
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| S. Bolar
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| Vol #:
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| 68
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| C 1372
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| T. Cafferty
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| Vol #:
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| 68
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| C 1373
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| R. Steinfurth
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| Vol #:
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| 68
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| C 1374
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| L. Vavrick
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| Vol #:
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| 68
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| C 1375
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| V. Sawyer
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| Vol #:
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| 68
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| C 1376
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| S. Guerrero
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| Vol #:
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| 68
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| C 1377
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| E. Boyd
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| Vol #:
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| 68
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| C 1378
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| R. Schroeter
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| Vol #:
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| 68
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| C 1379
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| A. Klein
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| Vol #:
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| 68
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| C 1380
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| O. Bielawski
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| Vol #:
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| 68
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| C 1381
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| L. Deets
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| Vol #:
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| 68
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| C 1382
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| L. Deets
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| Vol #:
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| 68
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| C 1383
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| R. Anderlik
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| Vol #:
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| 68
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| C 1384
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| M. Gordon
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| Vol #:
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| 68
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| C 1385
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| J. Turner
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| Vol #:
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| 68
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| C 1386
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| N. Andresen
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| Vol #:
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| 68
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| |
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| C 1387
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| J. Filip
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| Vol #:
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| 68
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| C 1388
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| C. Wolfe
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| Vol #:
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| 68
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| |
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| C 1389
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| M. Mangiarelli
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| Vol #:
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| 68
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| |
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| C 1390
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| C. Johnson
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| Vol #:
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| 68
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| |
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| C 1391
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| D. Silverman
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| Vol #:
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| 68
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| |
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| C 1392
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| L. Doleshal
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| Vol #:
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| 68
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| |
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| C 1393
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| J. Shore
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| Vol #:
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| 68
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|
| | | | | | | |
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| C 1394
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| J. Lester
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| Vol #:
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| 68
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| |
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| C 1395
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| D. Iregui
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| Vol #:
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| 68
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| |
|
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| C 1396
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| D. Jankowski
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| Vol #:
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| 68
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| |
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| C 1397
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| M. Argo
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| Vol #:
|
| 68
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| |
|
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| C 1398
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| Y. Silva
|
| Vol #:
|
| 68
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| |
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| C 1399
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| M. Gilbert
|
| Vol #:
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| 68
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| |
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| C 1400
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| L. Franks
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| Vol #:
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| 68
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| |
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| C 1401
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| N. Procopio
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| Vol #:
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| 68
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| |
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| C 1402
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| S. Johnson
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| Vol #:
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| 68
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| |
|
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| C 1403
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| C. Huleva
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| Vol #:
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| 68
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| |
|
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| C 1404
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| A. Dellago
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| Vol #:
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| 68
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| |
|
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| C 1405
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| K. Marin
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| Vol #:
|
| 68
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| |
|
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| C 1406
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| M. McDonald
|
| Vol #:
|
| 68
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| |
|
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| C 1407
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| C. Madden
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| Vol #:
|
| 68
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| |
|
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| C 1408
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| T. Hicks
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| Vol #:
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| 68
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| |
|
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| C 1409
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| G. Haley
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| Vol #:
|
| 68
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| |
|
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| C 1410
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| L. Hamblin
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| Vol #:
|
| 68
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| |
|
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| C 1411
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| K. Genetive
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| Vol #:
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| 68
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| |
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| C 1412
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| M. Neilsen
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| Vol #:
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| 68
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| |
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| C 1413
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| P. Gerresheim
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| Vol #:
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| 68
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| |
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| C 1414
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| A. Cabada
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| Vol #:
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| 68
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| |
|
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| C 1415
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| M. Lasater
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| Vol #:
|
| 68
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| |
|
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| C 1416
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| M. Aitken
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| Vol #:
|
| 68
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| |
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| C 1417
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| L. Wells
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| Vol #:
|
| 68
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| |
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| C 1418
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| J. Martin
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| Vol #:
|
| 68
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| |
|
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| C 1419
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| T. Newman
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| Vol #:
|
| 68
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| |
|
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| C 1420
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| A. Drechaler
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| Vol #:
|
| 68
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| |
|
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| C 1421
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| S. Greenlee
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| Vol #:
|
| 68
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| |
|
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| C 1422
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| K. Goetze
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| Vol #:
|
| 68
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| |
|
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| C 1423
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| V. Barro
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| Vol #:
|
| 68
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| |
|
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| C 1424
|
| K. Wyatt
|
| Vol #:
|
| 68
|
| |
|
|
| C 1425
|
| A. Alessandra
|
| Vol #:
|
| 68
|
| |
|
|
| C 1426
|
| B. Towles
|
| Vol #:
|
| 68
|
| |
|
|
| C 1427
|
| C. Graney
|
| Vol #:
|
| 68
|
| |
|
|
| C 1428
|
| C. Haia
|
| Vol #:
|
| 68
|
| |
|
|
| C 1429
|
| J. Brown
|
| Vol #:
|
| 68
|
| |
|
|
| C 1430
|
| J. Slominski
|
| Vol #:
|
| 68
|
|
| | | | | | | | |
|
| |
|
| C 1431
|
| P. Newman
|
| Vol #:
|
| 68
|
| |
|
|
| C 1432
|
| M. McCormick
|
| Vol #:
|
| 68
|
| |
|
|
| C 1433
|
| M. Robichaud
|
| Vol #:
|
| 68
|
| |
|
|
| C 1434
|
| C. Mozuch
|
| Vol #:
|
| 68
|
| |
|
|
| C 1435
|
| R. Simmons
|
| Vol #:
|
| 68
|
| |
|
|
| C 1436
|
| K. Barowitz
|
| Vol #:
|
| 68
|
| |
|
|
| C 1437
|
| D. Rasnake
|
| Vol #:
|
| 68
|
| |
|
|
| C 1438
|
| P. Patterson
|
| Vol #:
|
| 68
|
| |
|
|
| C 1439
|
| B. Luther
|
| Vol #:
|
| 68
|
| |
|
|
| C 1440
|
| N. Lubin
|
| Vol #:
|
| 68
|
| |
|
|
| C 1441
|
| J. Bruning
|
| Vol #:
|
| 68
|
| |
|
|
| C 1442
|
| SD Coggin
|
| Vol #:
|
| 68
|
| |
|
|
| C 1443
|
| C. Zimmerman
|
| Vol #:
|
| 68
|
| |
|
|
| C 1444
|
| A. White
|
| Vol #:
|
| 68
|
| |
|
|
| C 1445
|
| D. Adney
|
| Vol #:
|
| 207
|
| |
|
|
| C 1446
|
| L. Eagle
|
| Vol #:
|
| 207
|
| |
|
|
| C 1447
|
| H. Walker
|
| Vol #:
|
| 207
|
| |
|
|
| C 1448
|
| L. Kroll
|
| Vol #:
|
| 207
|
| |
|
|
| C 1449
|
| C. Airing
|
| Vol #:
|
| 207
|
| |
|
|
| C 1450
|
| P. Moss
|
| Vol #:
|
| 207
|
| |
|
|
| C 1451
|
| D. Gagliarducci
|
| Vol #:
|
| 207
|
| |
|
|
| C 1452
|
| S. Campbell
|
| Vol #:
|
| 207
|
| |
|
|
| C 1453
|
| M. Valli
|
| Vol #:
|
| 207
|
| |
|
|
| C 1454
|
| W. Herbert
|
| Vol #:
|
| 207
|
| |
|
|
| C 1455
|
| K. Piazza
|
| Vol #:
|
| 207
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18315
|
| L. Calmes
|
| Vol #:
|
| 198
|
|
| |
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
|
|
| |
|
|
| SUP 4
|
| Wyeth Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 99
|
| C. Maszk, T. Green & J. Green
|
| Vol #:
|
| 7
|
| |
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
| | |
|
|
| C 3
|
| Schering-Plough
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| C 4
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| Novartis Pharmaceuticals Corp.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| sanofi-aventis
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Perrigo Company
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 266
|
| Melfi, Catherine
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 267
|
| Mehta, Rikin
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 268
|
| Vincent, Andrea
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 269
|
| De Santis, Marta
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 270
|
| Robbins, Gabriel
|
| Vol #:
|
| 7
|
|
| |
|
| 2007P-0224
|
| ANDA Suitability Petition for NDA 21-774 Ambien CR (Zolpidem tartrate)
|
| |
|
|
| ACK 1
|
| FDA/DDM to Sanofi Aventis U.S. Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Sanofi Aventis U.S. Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0226
|
| to permit an ANDA suitability for Donepezil Hydrochloride Orally Dissolving Film Stripps, 5 mg and 10 mg
|
| |
|
|
| ACK 1
|
| FDA / DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
