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| Dockets Entered
On September 28, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-1589
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| Stay effective date of approval for NDA 20-932 Roxicodone
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002F-0316
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| Safe Use of Mix of Bacteriofages/Antimicrobial Agent
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006N-0105
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0277
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0378
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| Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance with the Medical Device User Fee and Modernization Act of 2002
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0316
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| Health Claim: Phytosterols and Reduced Risk of Coronary Heart Disease
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| 2006P-0393
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| Health Claim Petition; Barley Betafiber and Cornary Heart Disease
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| 2006P-0395
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| To permit an ANDA Suitability for Metoprolol Tartrate Tablets
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 26
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| K. Rodan, M.D.
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| Vol #:
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| 4
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4431
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| M. Peppersorn
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| Vol #:
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| 320
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 651
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| S. Olson
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| Vol #:
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| 24
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| EMC 652
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| D. Miliman
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| Vol #:
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| 24
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| EMC 653
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| No signature
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| Vol #:
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| 24
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| EMC 654
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| D. Robson
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| Vol #:
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| 24
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| EMC 655
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| Christine
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| Vol #:
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| 24
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| 1999P-1589
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| Stay effective date of approval for NDA 20-932 Roxicodone
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| OB 68
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| R. Fuller
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| Vol #:
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| 1
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| OB 69
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| Food & Water Watch
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 701
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| Mission Possiblke International
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| Vol #:
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| 10
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| EMC 702
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| Mission Possiblke International
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| Vol #:
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| 10
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| EMC 703
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| Mission Possiblke International
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| Vol #:
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| 10
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| EMC 704
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| Mission Possiblke International
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| Vol #:
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| 10
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1342
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| M. Helmer
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| Vol #:
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| 12
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| EMC 1343
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| C. Owen
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| Vol #:
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| 12
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| EMC 1344
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| L. Bratvogel
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| Vol #:
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| 12
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| EMC 1345
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| T. Fikes
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| Vol #:
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| 12
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| EMC 1346
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| C. Colvin
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| Vol #:
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| 12
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| EMC 1347
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| No signature
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| Vol #:
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| 12
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| EMC 1348
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| J. Bailey
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| Vol #:
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| 12
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| EMC 1349
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| J. Wikan
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| Vol #:
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| 12
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| EMC 1350
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| R. McStay
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| Vol #:
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| 12
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 22
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| Mrs. Laura Bruce
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| Vol #:
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| 2
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| EMC 303
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| L. Bichler
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| Vol #:
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| 5
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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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| EMC 10
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| D. Mullan
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| Vol #:
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| 2
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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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| EMC 3909
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| M. Paquin
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| Vol #:
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| 195
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| EMC 3910
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| S. Brady
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| Vol #:
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| 195
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| EMC 3911
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| C. Johnston
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| Vol #:
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| 195
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| EMC 3912
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| S. Coleman
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| Vol #:
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| 195
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| EMC 3913
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| D. Cuff
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| Vol #:
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| 195
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| EMC 3914
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| D. Knudsen
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| Vol #:
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| 195
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| EMC 3915
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| W. Gilfillan
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| Vol #:
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| 195
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| EMC 3916
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| T. Matteo
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| Vol #:
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| 195
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| EMC 3917
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| L. Eckhardt
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| Vol #:
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| 195
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| | | | | | | | |
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| EMC 3955
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| V. Rivera
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| Vol #:
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| 195
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| EMC 3956
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| D. Solomon
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| Vol #:
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| 195
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| EMC 3957
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| University of Illinois-Chicago
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| Vol #:
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| 195
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| EMC 3958
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| A. Marini
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| Vol #:
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| 195
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| EMC 3959
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| D. Dimond
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| Vol #:
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| 195
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| EMC 3960
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| J. Tregre
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| Vol #:
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| 195
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| EMC 3961
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| M. Walhout
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| Vol #:
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| 195
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| EMC 3962
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| D. Pell
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| Vol #:
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| 195
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| APE 1
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| University of Maryland School of Medicine
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| Vol #:
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| 2
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| APE 2
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| CIRCARE
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| Vol #:
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| 2
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| C 4
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| Society for Academic Emergency Medicine (SAEM)
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| Vol #:
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| 2
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| C 5
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| American College of Emergency Physicians (ACEP)
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| Vol #:
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| 2
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| EC 33
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| National Organization for Rare Disorders (NORD)
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| Vol #:
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| 2
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| TS 1
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| University of Texas Southwestern Medical Center and the Parkland Health and Hospital System
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| Vol #:
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| 2
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| 2006N-0105
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| C 6
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| M. Dube
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| Vol #:
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| 1
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| EMC 1
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| W. McMullin
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| Vol #:
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| 1
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| 2006N-0277
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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| EMC 1
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| American Herbal Products Association (AHPA)
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| Vol #:
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| 1
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| |
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| EMC 317
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| Dr. P. Gilbert
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| Vol #:
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| 6
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| EMC 318
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| A. Siess, Jr.
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| Vol #:
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| 6
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| EMC 319
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| Uppsala University
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| Vol #:
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| 6
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| EMC 320
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| G. Burke
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| Vol #:
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| 6
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| EMC 321
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| B. Osmunson, DDS, MPH
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| Vol #:
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| 6
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| EMC 322
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| M. Adjodha
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| Vol #:
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| 6
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| EMC 323
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| No signature
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| Vol #:
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| 6
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| EMC 324
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| S. Markus
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| Vol #:
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| 6
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| EMC 325
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| E. McDonagh
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| Vol #:
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| 6
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| EMC 326
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| P. Windham
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| Vol #:
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| 6
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| EMC 327
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| Drs. D and J. Cretsinger (DC)
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| Vol #:
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| 6
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| | | | | | | | |
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| |
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| EMC 328
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| S. Rosenthal
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| Vol #:
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| 6
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| EMC 329
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| K. Truskowski
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| Vol #:
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| 6
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| EMC 330
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| N. Toth
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| Vol #:
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| 6
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| EMC 331
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| J. Imbeau D.M.D.
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| Vol #:
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| 6
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| EMC 332
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| L. McCombie
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| Vol #:
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| 6
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| EMC 333
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| A. Smith
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| Vol #:
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| 6
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| EMC 334
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| American Academy of Pediatric Dentistry (AAPD)
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| Vol #:
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| 6
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| EMC 335
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| J. Whittlesey
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| Vol #:
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| 6
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| EMC 336
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| V. MacKay, M.S.
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| Vol #:
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| 6
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| EMC 337
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| C. Leighton
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| Vol #:
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| 6
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| EMC 338
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| A. King
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| Vol #:
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| 6
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| EMC 339
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| M. Grath
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| Vol #:
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| 6
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| EMC 340
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| S. Cooper
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| Vol #:
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| 6
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| EMC 341
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| M. Newell
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| Vol #:
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| 6
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| 2006N-0378
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| Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance with the Medical Device User Fee and Modernization Act of 2002
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|
|
|
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| N 1
|
| FDA
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| Vol #:
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| 1
|
|
|
|
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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|
|
|
| EMC 2
|
| Nordic School of Public Health and University of Uppsala
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| Vol #:
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| 1
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| 2006P-0316
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| Health Claim: Phytosterols and Reduced Risk of Coronary Heart Disease
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| EMC 1
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| Origo Biosciences, Inc.
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| Vol #:
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| 3
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|
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| 2006P-0393
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| Health Claim Petition; Barley Betafiber and Cornary Heart Disease
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| ACK 1
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| FDA/CFSAN to Cargill, Incorporated
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| Vol #:
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| 4
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| CP 1
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| Cargill, Incorporated
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| Vol #:
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| 1
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| LET 1
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| Cargill, Incorporated
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| Vol #:
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| 4
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| LET 2
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| Cargill, Incorporated
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| Vol #:
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| 4
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| LET 3
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| Cargill, Incorporated
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| Vol #:
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| 4
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| LET 4
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| FDA/CFSAN to Cargill, Incorporated
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| Vol #:
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| 4
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|
|
|
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| 2006P-0395
|
| To permit an ANDA Suitability for Metoprolol Tartrate Tablets
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|
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| ACK 1
|
| FDA / DDM to Kendle International
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| Vol #:
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| 1
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| CP 1
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| Kendle International
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| Vol #:
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| 1
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