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| Dockets Entered
On March 26, 2007
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| Docket #
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| Title
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2077
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| Reg/Guide to Label Medical Devices contain'g Phthalate Plast
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| 1999P-2775
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| Refuse abbreviated new drug application for gabapentin tablt
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| 1999P-4871
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| ANDA for Sterile Cefuroxime Sodium, USP
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| 2000P-0653
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| Amend the product insert &/or label for Anthrax Vaccive adso
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| 2000P-1468
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| ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m
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| 2000P-1550
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| Approve ANDA for Cefuroxime Axetil Products
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| 2000P-1568
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| ANDA Suitability Petition for Ursodiol Oral Suspension
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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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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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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| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0528
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
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| 2006P-0255
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| discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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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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| 2006P-0498
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| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
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| 2007D-0020
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| Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
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|
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| 2007D-0027
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| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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|
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| 2007P-0113
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| ANDA Suitability for 15% Amino Acid Injection Product
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| |
|
| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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|
|
| EREG 1
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| Consumer Healthcare Products Association
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| Vol #:
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| 1
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|
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| |
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| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
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| |
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| EMC 675
|
| L. Colquhoun
|
| Vol #:
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| 24
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|
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| 1999P-2077
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| Reg/Guide to Label Medical Devices contain'g Phthalate Plast
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|
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| RET 1
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| 88-07-0027 Box 1
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| Vol #:
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| 3
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|
| |
|
| 1999P-2775
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| Refuse abbreviated new drug application for gabapentin tablt
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| |
|
|
| RET 1
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| 88-07-0027 Box 1
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| Vol #:
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| 1
|
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|
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| 1999P-4871
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| ANDA for Sterile Cefuroxime Sodium, USP
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|
|
| RET 1
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| 88-07-0027 Box 1
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| Vol #:
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| 1
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| |
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|
| 2000P-0653
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| Amend the product insert &/or label for Anthrax Vaccive adso
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|
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| RET 1
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| 88-07-0027 Box 1
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| Vol #:
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| 1
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|
|
| 2000P-1468
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| ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m
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| |
|
|
| RET 1
|
| 88-07-0027 Box 1
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| Vol #:
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| 1
|
| |
|
|
| 2000P-1550
|
| Approve ANDA for Cefuroxime Axetil Products
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| |
|
|
| RET 1
|
| 88-07-0027 Box 1
|
| Vol #:
|
| 2
|
| |
|
|
| 2000P-1568
|
| ANDA Suitability Petition for Ursodiol Oral Suspension
|
| |
|
|
| RET 1
|
| 88-07-0027 Box 2
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| Vol #:
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| 1
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 784
|
| Mission Possible International
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 785
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| Mission Possible International
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| Vol #:
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| 10
|
| |
|
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| |
|
|
| EMC 1464
|
| J. Agro
|
| Vol #:
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| 12
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|
|
| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| |
|
|
| EREG 5
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| American Veterinary Medical Association
|
| Vol #:
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| 15
|
| |
|
|
| EREG 6
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| American Veterinary Medical Association
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| Vol #:
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| 15
|
| |
|
|
| EREG 7
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| Council of State and Territorial Epidemiologists
|
| Vol #:
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| 15
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| |
|
|
| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
|
|
| C 442
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| D. Parris
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| Vol #:
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| 41
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| C 443
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| S. Shankle
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| Vol #:
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| 41
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| C 444
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| M. Johanns
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| Vol #:
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| 41
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| C 445
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| T. Siegrist
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| Vol #:
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| 41
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| EC 3801
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| Ms. Natz Sherwin
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| Vol #:
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| 22
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| EC 3802
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| Miss. Elizabeth Lopez
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| Vol #:
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| 22
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| EC 3803
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| Mrs. Debra Clinton
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| Vol #:
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| 22
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| EC 3804
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| Ms. Maureen Edwards
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| Vol #:
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| 22
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| EC 3805
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| Miss. Lisa Liu
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| Vol #:
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| 22
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| EC 3806
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| Dr. Tracy Ouellette
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| Vol #:
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| 22
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| EC 3807
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| Mr. John Fenker
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| Vol #:
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| 22
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| EC 3808
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| Miss. Lisa Rae
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| Vol #:
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| 22
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| |
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| EC 3809
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| Miss. Cindy Griffith
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| Vol #:
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| 22
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| |
|
|
| EC 3810
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| Mrs. Tami Johnson
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| Vol #:
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| 22
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| |
|
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| EC 3811
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| Ms. debbie borgono
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| Vol #:
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| 22
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| EC 3812
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| Dr. Eugene B. Hanlon
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| Vol #:
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| 22
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| EC 3813
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| Miss. Laura Holmes
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| Vol #:
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| 22
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| EC 3814
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| Dr. Lisa Johnston
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| Vol #:
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| 22
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| EC 3815
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| Mr. Joseph Sapere
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| Vol #:
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| 22
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| EC 3816
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| Mr. Eric Thompson
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| Vol #:
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| 22
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| EC 3817
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| WSPCA
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| Vol #:
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| 22
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| EC 3818
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| Mrs. Donna Selquist
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| Vol #:
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| 22
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| EC 3819
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| Mr. Walter Lee IV
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| Vol #:
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| 22
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|
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| EC 3820
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| Dr. Ellen Pill
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| Vol #:
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| 22
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| EC 3821
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| Mrs. Suzanne Jenuleson
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| Vol #:
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| 22
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|
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| EC 3822
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| Ms. Pam Carey
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| Vol #:
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| 22
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|
|
| EC 3823
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| Mr. John Teevan
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| Vol #:
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| 22
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| EC 3824
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| Fundacin Altarriba
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| Vol #:
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| 22
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| EC 3825
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| Ms. Kristina Wetzel
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| Vol #:
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| 22
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| EC 3826
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| Dr. Krista Luck
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| Vol #:
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| 22
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| EC 3827
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| Ms. Monica Willett
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| Vol #:
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| 22
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|
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| EC 3828
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| Miss. Kirsten Bracht
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| Vol #:
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| 22
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|
|
| EC 3829
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| Mrs. Jasey Carrick
|
| Vol #:
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| 22
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|
| EC 3830
|
| Mrs. jamie kordack
|
| Vol #:
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| 22
|
| |
|
|
| EC 3831
|
| Institute for Advanced Study
|
| Vol #:
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| 22
|
| |
|
|
| EC 3832
|
| Miss. Adrienne Dollyhigh
|
| Vol #:
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| 22
|
| |
|
|
| EC 3833
|
| Mrs. Nikola Garvey
|
| Vol #:
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| 22
|
| |
|
|
| EC 3834
|
| Miss. kristen chapman
|
| Vol #:
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| 22
|
| |
|
|
| EC 3835
|
| Miss. Kate Cushen
|
| Vol #:
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| 22
|
| |
|
|
| EC 3836
|
| Ms. Carole Smudin
|
| Vol #:
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| 22
|
| |
|
|
| EC 3837
|
| Ms. Deanne O'Donnell
|
| Vol #:
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| 22
|
|
| | | | | | | |
|
| |
|
| EC 3838
|
| Miss. Emanuel van der Wiel
|
| Vol #:
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| 22
|
| |
|
|
| EC 3839
|
| Ms. Karen Ryder
|
| Vol #:
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| 22
|
| |
|
|
| EC 3840
|
| Mrs. Mikiko Takagi
|
| Vol #:
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| 22
|
| |
|
|
| EC 3841
|
| Ms. Laura Schatzkin
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3842
|
| Mrs. Mikiko Takagi
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3843
|
| Ms. jo gabriel
|
| Vol #:
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| 22
|
| |
|
|
| EC 3844
|
| Ms. Lacey Levitt
|
| Vol #:
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| 22
|
| |
|
|
| EC 3845
|
| Ms. Erika Villani
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3846
|
| Miss. katie sinclair
|
| Vol #:
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| 22
|
| |
|
|
| EC 3847
|
| Ms. J. Ackerman
|
| Vol #:
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| 22
|
| |
|
|
| EC 3848
|
| Ms. Harriet Bryan
|
| Vol #:
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| 22
|
| |
|
|
| EC 3849
|
| Mrs. Moselle Irr
|
| Vol #:
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| 22
|
| |
|
|
| EC 3850
|
| Miss. Stacie West
|
| Vol #:
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| 22
|
| |
|
|
| EC 3851
|
| Ms. Heather Rogers
|
| Vol #:
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| 22
|
| |
|
|
| EC 3852
|
| Mr. Ryan Smith
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3853
|
| Mr. Roberto de Moraes
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3854
|
| Miss. Elissar Khalek
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3855
|
| Mr. Patrick Morin
|
| Vol #:
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| 22
|
| |
|
|
| EC 3856
|
| Miss. Sarah Pruitt
|
| Vol #:
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| 22
|
| |
|
|
| EC 3857
|
| The National Humane Education Society (NHES)
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3858
|
| Center for Corporate Citizenship, Boston College
|
| Vol #:
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| 22
|
| |
|
|
| EC 3859
|
| Ms. Greta Ratliff
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3860
|
| Mrs. Kelle Bruckman
|
| Vol #:
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| 22
|
| |
|
|
| EC 3861
|
| Individual
|
| Vol #:
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| 22
|
| |
|
|
| EC 3862
|
| Los Alamos National Laboratory
|
| Vol #:
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| 22
|
| |
|
|
| EC 3863
|
| Mr. Rodney ANderson
|
| Vol #:
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| 22
|
| |
|
|
| EC 3864
|
| Ms. Heather Schmaedeke
|
| Vol #:
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| 22
|
| |
|
|
| EC 3865
|
| Sonoma people For ANIMAL Rights
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3866
|
| Ms. Elizabeth Mostov
|
| Vol #:
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| 22
|
| |
|
|
| EC 3867
|
| Ms. Ellen NeSmith
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3868
|
| Mr. Ravi Grover
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3869
|
| Ms. Catherine Anderson
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3870
|
| Mrs. Rebecca Roberts
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3871
|
| Ms. Felicia Watkins
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3872
|
| Mrs. Karen Fedorov
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3873
|
| Miss. Thandi Felix
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3874
|
| Ms. Karen Magee
|
| Vol #:
|
| 22
|
|
| | | | | | | | |
|
| |
|
| EC 3875
|
| Ms. J Hutchinson
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3876
|
| Ms. Deanka Grisham
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3877
|
| Mrs. Christa Boroskin
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3878
|
| Mrs. Judy Ferraiolo
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3879
|
| Mr. Matthew Herrin
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3880
|
| Ms. Claudia Campeanu
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3881
|
| Mr. Ricky Atkins
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3882
|
| Mrs. Kathy Johnson
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3883
|
| Ms. Alexis Martin
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3884
|
| Mrs. Laura Rowles
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3885
|
| Miss. Alexandra Teixeira
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3886
|
| Mr. yati sivam
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3887
|
| Ms. Amanda Graham
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3888
|
| Mr. David Nielsen
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3889
|
| Mrs. Lisa Merrell
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3890
|
| Ms. Tanya Marie Cope
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3891
|
| Mrs. Aracelis Jaffe
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3892
|
| Ms. ENA SILVA VILLACORTA
|
| Vol #:
|
| 22
|
|
| |
|
| 2005E-0259
|
| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| CS 22
|
| FDA/DDM
|
| Vol #:
|
| 240
|
| |
|
|
| CS 23
|
| FDA/DDM
|
| Vol #:
|
| 240
|
| |
|
|
| LET 7
|
| Administrative Law Judge
|
| Vol #:
|
| 240
|
| |
|
|
| MO 23
|
| TMJ Implants, Inc, and Robert W. Christensen, and Maureen K Mooney
|
| Vol #:
|
| 240
|
| |
|
|
| OR 22
|
| Administrative Law Judge
|
| Vol #:
|
| 240
|
| |
|
|
| RC 1
|
| FDA/CDRH to TMJ Implants, Inc., Dr. Robert W. Christensen, and Maureen K Mooeney
|
| Vol #:
|
| 240
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EC 1860
|
| Mr. Chester Burgess
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1861
|
| Ms. Ashley Enderlin
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1862
|
| Mr. Brian Fragassi
|
| Vol #:
|
| 31
|
| |
|
|
| EREG 51
|
| A. Gatch
|
| Vol #:
|
| 32
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18278
|
| A. Jacobi
|
| Vol #:
|
| 198
|
|
| | | | | | | | |
|
| |
|
| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| |
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| N 1
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| FDA
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| Vol #:
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| 1
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| |
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| |
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| N 1
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| FDA
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| Vol #:
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| 1
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| |
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| |
|
|
| N 1
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| FDA
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| Vol #:
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| 1
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| |
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| |
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|
| C 24
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| Pendergast Consulting
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| Vol #:
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| 1
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| |
|
|
| EMC 1
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| B. Yarczower MD
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| Vol #:
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| 1
|
| |
|
|
| 2006N-0528
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
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| |
|
|
| N 2
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| FDA
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| Vol #:
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| 1
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| |
|
|
| 2006P-0255
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| discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
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| |
|
|
| N 1
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| FDA
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| Vol #:
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| 1
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| |
|
|
| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| |
|
|
| PAV 1
|
| FDA/CDER to Lachman Consultant Services Inc
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| Vol #:
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| 1
|
|
| |
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
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| |
|
|
| C 74
|
| A. Fritz
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| Vol #:
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| 7
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| |
|
|
| C 75
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| R. A. Christopher
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| Vol #:
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| 7
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| |
|
|
| C 76
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| J. Kramer
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| Vol #:
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| 7
|
| |
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
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| |
|
|
| C 82
|
| M Grace
|
| Vol #:
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| 1
|
| |
|
|
| C 83
|
| Plumas Rural Services WIC - Women, Infants, & Children
|
| Vol #:
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| 1
|
| |
|
|
| C 84
|
| R Ditta
|
| Vol #:
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| 1
|
| |
|
|
| C 85
|
| C Newman
|
| Vol #:
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| 1
|
| |
|
|
| C 86
|
| D Nuss
|
| Vol #:
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| 1
|
| |
|
|
| C 87
|
| C Travers
|
| Vol #:
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| 1
|
| |
|
|
| C 88
|
| J Palmer
|
| Vol #:
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| 1
|
| |
|
|
| 2007D-0020
|
| Medical Devices: Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
|
| |
|
|
| EXT 1
|
| Number not used
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
| |
|
| 2007D-0027
|
| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
|
| |
|
|
| EXT 1
|
| American Feed Industry Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| TR 1
|
| Transcript of the March 7, 2007 meeting
|
| Vol #:
|
| 4
|
| |
|
|
| TR 2
|
| Transcript of the March 8, 2007 meeting
|
| Vol #:
|
| 5
|
| |
|
|
| TS 12
|
| GlaxoSmithKline
|
| Vol #:
|
| 3
|
| |
|
|
| TS 13
|
| Cerner Corporation, Cerner Galt Division
|
| Vol #:
|
| 3
|
| |
|
|
| TS 14
|
| Stephen A Goldman Consulting Services LLC
|
| Vol #:
|
| 3
|
| |
|
|
| TS 15
|
| GE Healthcare, Practice Solutions
|
| Vol #:
|
| 3
|
| |
|
|
| TS 16
|
| Johnson & Johnson
|
| Vol #:
|
| 3
|
| |
|
|
| TS 17
|
| AAFP National Research Network
|
| Vol #:
|
| 3
|
| |
|
|
| TS 18
|
| Applied Clinical Intelligence LLC, American Pharmacist Association Collaboration
|
| Vol #:
|
| 3
|
| |
|
|
| TS 19
|
| Community MTM Services Inc
|
| Vol #:
|
| 3
|
| |
|
|
| TS 20
|
| Quintiles Inc
|
| Vol #:
|
| 3
|
| |
|
|
| TS 21
|
| Exponent Inc
|
| Vol #:
|
| 3
|
| |
|
|
| TS 22
|
| CDISC
|
| Vol #:
|
| 3
|
| |
|
|
| TS 23
|
| Pfizer
|
| Vol #:
|
| 3
|
| |
|
|
| TS 24
|
| Novlis
|
| Vol #:
|
| 3
|
| |
|
|
| TS 25
|
| ProSanos Corporation
|
| Vol #:
|
| 3
|
| |
|
|
| TS 26
|
| ECRI
|
| Vol #:
|
| 3
|
| |
|
|
| TS 27
|
| Northrop Grumman
|
| Vol #:
|
| 3
|
| |
|
|
| TS 28
|
| Sermo In
|
| Vol #:
|
| 3
|
| |
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
| |
|
|
| C 1
|
| National Confectioners Association
|
| Vol #:
|
| 2
|
| |
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
|
|
| | |
|
|
| LET 1
|
| Arbor Hill Grapery
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0113
|
| ANDA Suitability for 15% Amino Acid Injection Product
|
| |
|
|
| ACK 1
|
| FDA / DDM to B Braun Medical, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| B Braun Medical, Inc.
|
| Vol #:
|
| 1
|
|
|
