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| Dockets Entered
On November 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| 2005N-0375
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| Stakeholder Meeting on the Implementation of a New Direction for Radiological Health Program; Public Meeting
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| 2005P-0480
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| Meloxicam, Orally Disintegrating Tablets, 7.5 mg and 15 mg is suitable for submission as an ANDA
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
297
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| Vigconic (International) Ltd
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| Vol #:
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| 232
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16908
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16909
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16910
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16911
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16912
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16913
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16914
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16915
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16916
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16917
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16918
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16919
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16920
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16921
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16922
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| Natural Organics Inc.
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| Vol #:
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| 153
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| LET
16923
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| GreenChung (USA), Inc.
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| Vol #:
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| 153
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| LET
16924
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| Apex Fitness Group
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| Vol #:
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| 153
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| LET
16925
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| Optigenex Inc.
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| Vol #:
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| 153
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| LET
16926
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| Superbalife International, LLC
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| Vol #:
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| 153
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| LET
16927
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| Indian Botanic Gardens, Inc.
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| Vol #:
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| 153
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| LET
16928
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 153
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| LET
16929
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| Hyalogic LLC
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| Vol #:
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| 153
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| LET
16930
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| Hyalogic LLC
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| Vol #:
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| 153
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| LET
16931
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| Jarrow Formulas
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| Vol #:
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| 153
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| LET
16932
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| Jarrow Formulas
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| Vol #:
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| 153
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| LET
16933
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| Nature's Way
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| Vol #:
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| 153
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| C
40
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| Center for Disease Control and Prevention (CDC)
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| Vol #:
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| 3
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| EC
2
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| Biotechnology Industry Organization
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| Vol #:
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| 1
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| EC
3
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| Merck
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| Vol #:
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| 1
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| EC
4
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| Schering Plough Corporation
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| Vol #:
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| 1
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| EC
5
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| Targeted Genetics Corporation
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| Vol #:
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| 1
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| EMC
1
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| Biotechnology Industry Organization
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| Vol #:
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| 1
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| EMC
2
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| Cell Genesys Inc
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| Vol #:
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| 1
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| EMC
3
Attachment
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| European Medicines Agency (EMEA)
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| Vol #:
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| 1
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| EXT
1
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| International Center for Technology Assessment
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| Vol #:
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| 1
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| 2005N-0375
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| Stakeholder Meeting on the Implementation of a New Direction for Radiological Health Program; Public Meeting
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| TR
1
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| Transcript of the October 31, 2005 Radiological Health Program Stakeholder Meeting
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| Vol #:
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| 2
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| LST
1
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| Agenda for November 17, 2005 Public Meeting
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| Vol #:
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| 2
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| REF
1
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| Full Information for Each FDA Study Health Claim
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| Vol #:
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| 2
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| TS
1
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| HHS Office of the General Counsel
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| Vol #:
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| 2
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| TS
2
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| FDA, CFSAN. Office of Nutritional Products, Labeling and Dietary Supplements
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| Vol #:
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| 2
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| TS
3
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| FDA, Center for Food Safety and Applied Nutrition
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| Vol #:
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| 2
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| TS
4
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| FDA, Office of Regulatory Affairs
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| Vol #:
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| 2
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| TS
5
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| Pauline M Ippolito, FTC
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| Vol #:
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| 2
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| TS
6
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| International Food Information Council (IFIC) and IFIC Foundation
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| Vol #:
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| 2
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| TS
7
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| West Virginia University
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| Vol #:
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| 2
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| TS
8
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| Ohio State University, Department of Agricultural, Environmental, and Development Economics
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| Vol #:
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| 2
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| 2005P-0352
|
| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| C
3
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| IMPAX Laboratories Inc
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| Vol #:
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| 2
|
|
|
|
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| 2005P-0480
|
| Meloxicam, Orally Disintegrating Tablets, 7.5 mg and 15 mg is suitable for submission as an ANDA
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| ACK
1
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| HFA-305 to Camargo Pharmaceutical Services
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| Vol #:
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| 1
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