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| Dockets Entered
On June 8, 2004
Table of Contents
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| Docket #
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| Title
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| 1980N-0145B
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| Safety & Efficacy Review for OTC Ophthalmic Drug Prod.
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| 1986V-0366
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| LASER PROJECTOR MODELS 1C AND 3C
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| 1990V-0284
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| Laser Light Show (Laser Fantasy Rainbow Projector).
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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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| 2000N-1219
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| Bacterial Vaccines & Related Biological Products
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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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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| 2001V-0341
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| Laser Light Show
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| 2002D-0237
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| QIE Evaluation of Stability Data
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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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-0232
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| Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0296
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| Romano Cheese for Manufacturing Deviating From Identity Standard; Temporary Permit for Market Testing
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0441
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| ANDA suitability for metoprolol tartrate 12.5 mg tablets
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| 2003P-0548
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| Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| 2004P-0008
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| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004P-0141
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| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
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| 1980N-0145B
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| Safety & Efficacy Review for OTC Ophthalmic Drug Prod.
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| C
2
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| International Safety Equipment Assn (ISEA)
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| Vol #:
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| 1
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| 1986V-0366
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| LASER PROJECTOR MODELS 1C AND 3C
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| VRA
9
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| HFZ-300 to Magic Light Laser Imagery
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| Vol #:
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| 1
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| 1990V-0284
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| Laser Light Show (Laser Fantasy Rainbow Projector).
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| VRA
2
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| HFZ-300 to Dr. Feelgoods Inc.
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| Vol #:
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| 1
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| 2002D-0237
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| QIE Evaluation of Stability Data
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 174
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| K. Smith
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| Vol #:
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| 3
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| EMC 175
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| No signature
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| Vol #:
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| 3
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| EMC 176
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| S. McCauley
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| Vol #:
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| 3
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| EMC 177
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| S. McCauley
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| Vol #:
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| 3
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| C
4
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| Berlex, Inc.
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| Vol #:
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| 1
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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 193
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| No signature
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| Vol #:
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| 7
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| EMC 194
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| J. McCracken
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| Vol #:
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| 7
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| EMC 195
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| M. Magellan
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| Vol #:
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| 7
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| EMC 196
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| S. Hubbard
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| Vol #:
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| 7
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| EMC 197
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| M. Turner
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| Vol #:
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| 7
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| EMC 198
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| K. Wilkes
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| Vol #:
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| 7
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| EMC 199
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| R. White
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| Vol #:
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| 7
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| EMC 200
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| M. Smith
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| Vol #:
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| 7
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| EMC 201
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| H. Altimaier
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| Vol #:
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| 7
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| 2003N-0232
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| Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887
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| M
2
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| GCF-1
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| Vol #:
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| 1
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
2
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| Amphastar Pharmaceuticals, Inc.
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| Vol #:
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| 3
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| SUP
6
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 3
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 76
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| K. Gregg
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| Vol #:
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| 6
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| 2003P-0296
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| Romano Cheese for Manufacturing Deviating From Identity Standard; Temporary Permit for Market Testing
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| NTP
2
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| FDA
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| Vol #:
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| 1
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| SUP
7
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 5
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| 2003P-0441
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| ANDA suitability for metoprolol tartrate 12.5 mg tablets
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| LET 1
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| N. M. Saif, R.Ph.
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| Vol #:
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| 1
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| 2003P-0548
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| Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
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| LET
1
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| HFD-005 to GrayCary
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| Vol #:
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| 1
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| C
17
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| Free Hand Press
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| Vol #:
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| 2
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| C 18
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| L. Andre
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| Vol #:
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| 2
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| C 19
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| L Cadnum
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| Vol #:
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| 2
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| EMC 13
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| C. Kussman, RN, CDE
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| Vol #:
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| 1
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| EMC 14
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| D. Hadiji
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| Vol #:
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| 1
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| EMC 2
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| N. Stevens
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| Vol #:
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| 1
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| EMC 3
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| E. Heatwole
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| Vol #:
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| 1
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| 2004P-0008
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| Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
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| C 3
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| S.L. Kamechi
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| Vol #:
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| 1
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| EMC
1
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| Nutramax Laboratories, Inc.
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| Vol #:
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| 13
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| SUP
1
References
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| Weider Nutrition International, Inc.
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| Vol #:
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| 4
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| EMC
1
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| Nutramax Laboratories, Inc.
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| Vol #:
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| 1
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| 2004P-0141
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| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
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| EMC 1
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| Drug Royalty Corporation, Inc. (DRC)
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| Vol #:
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| 1
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