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| Dockets Entered
On May 4, 2004
Table of Contents
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| Docket #
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| Title
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| 1985N-0061D
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| General Requirements for Health Claims for Dietary Supplemen
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| 1990N-0135D
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| General Requirements for Nutrition Labeling for Dietary Supp
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| 1990V-0382
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| Request for Variance of a Laser Light Show
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| 1991N-0384D
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| Requirements for Nutrient Content Claims for Dietary Supp.
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| 1993N-0478
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| Dietary Supplements; Establishment of Date of Application
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| 1993N-0480A
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| Health Claims for Antioxidant Vitamins & Cancer
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| 1993N-0480C
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| Health Claims for Dietary Fiber & CVD
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| 1993N-0480F
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| Health Claims for Dietary Fiber & Cancer
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| 1993N-0480O
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| Health Claims; Omega-3 Fatty Acids & CHD
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| 1993N-0480Z
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| Health Claims for Zinc & Immune Deficiency in Elderly
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| 1993N-0481
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| Health Claims & Label Statements; Folate & NTD'S
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| 1997P-0078
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| Recognized the Term "Soymilk" as the Established Common of U
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 1999V-1717
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| Laser Light Show
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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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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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0245
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| ANDA for Fludarabine Phosphate Injection, 25 mg/ML
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| 2002P-0414
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| Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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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-0169
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| Dental Amalgam; Request for Information
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| 2003N-0324B
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| Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
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| 2003N-0324O
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| Oxytetracycline and neomycin fixed-combination Type A medicated articles
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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-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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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| | | | | | | | |
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| 2004D-0117
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| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
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| 2004D-0160
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| Use of Unapproved Hormone Implants in Veal Calves
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004P-0208
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| ANDA Suitability for Glipizide and Metformin HCl Tablets for Oral Suspension
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| 2004P-0209
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| ANDA Suitability for Glyburide and Metformin HCl Tablets for Oral Suspension
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| 2004V-0135
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| Laser Light Show
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|
| 1985N-0061D
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| General Requirements for Health Claims for Dietary Supplemen
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|
| LET
3
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| HFS-810
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| Vol #:
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| 39
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| 1990N-0135D
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| General Requirements for Nutrition Labeling for Dietary Supp
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| LET
3
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| HFS-810
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| Vol #:
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| 26
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|
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| 1990V-0382
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| Request for Variance of a Laser Light Show
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|
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|
|
| VRA
3
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| HFZ-300 to New Method Lasers, Inc.
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| Vol #:
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| 1
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|
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| 1991N-0384D
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| Requirements for Nutrient Content Claims for Dietary Supp.
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|
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| LET
2
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| HFS-810
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| Vol #:
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| 18
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| 1993N-0478
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| Dietary Supplements; Establishment of Date of Application
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| LET
2
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| HFS-810
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| Vol #:
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| 1
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| 1993N-0480A
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| Health Claims for Antioxidant Vitamins & Cancer
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| LET
1
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| HFS-810
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| Vol #:
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| 1
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| 1993N-0480C
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| Health Claims for Dietary Fiber & CVD
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| LET
2
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| HFS-810
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| Vol #:
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| 1
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| 1993N-0480F
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| Health Claims for Dietary Fiber & Cancer
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| LET
1
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| HFS-810
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| Vol #:
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| 1
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| 1993N-0480O
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| Health Claims; Omega-3 Fatty Acids & CHD
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|
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| LET
1
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| HFS-810
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| Vol #:
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| 1
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| 1993N-0480Z
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| Health Claims for Zinc & Immune Deficiency in Elderly
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|
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| LET
1
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| HFS-810
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| Vol #:
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| 1
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| 1993N-0481
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| Health Claims & Label Statements; Folate & NTD'S
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| | | | | | | | |
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|
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| LET
1
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| HFS-810
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| Vol #:
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| 1
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| 1997P-0078
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| Recognized the Term "Soymilk" as the Established Common of U
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|
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|
|
| C
166
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| National Milk Producers Federation (NMPF)
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| Vol #:
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| 2
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|
|
|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
|
|
|
| LET
13862
|
| Integrative Therapeutics Inc.
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| Vol #:
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| 118
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|
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|
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| LET
13863
|
| Integrative Therapeutics Inc.
|
| Vol #:
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| 118
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|
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|
|
| LET
13864
|
| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 118
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|
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|
|
| LET
13865
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 118
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|
|
|
|
| LET
13866
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 118
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|
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|
|
| LET
13867
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 118
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|
|
|
|
| LET
13868
|
| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 118
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|
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| LET
13869
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 118
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|
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| LET
13870
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 118
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| LET
13871
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 118
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| LET
13872
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 118
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|
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| LET
13873
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| Perrigo Company of South Carolina
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| Vol #:
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| 118
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| LET
13874
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| Perrigo Company of South Carolina
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| Vol #:
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| 118
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|
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| LET
13875
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| Perrigo Company of South Carolina
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| Vol #:
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| 118
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|
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| LET
13876
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| Integrative Therapeutics Inc.
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| Vol #:
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| 118
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|
|
|
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| LET
13877
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| Vitalstate, Inc.
|
| Vol #:
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| 118
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|
|
|
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| LET
13878
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| VitalState Innovative Technologies
|
| Vol #:
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| 118
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|
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|
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| LET
13879
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| FoodScience Corporation
|
| Vol #:
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| 118
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|
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|
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| LET
13880
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| Pharmanex, LLC
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| Vol #:
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| 118
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|
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| LET
13881
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| Pharmanex, LLC
|
| Vol #:
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| 118
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|
|
|
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| LET
13882
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| Pharmanex, LLC
|
| Vol #:
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| 118
|
|
|
|
|
| LET
13883
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| Pharmanex, LLC
|
| Vol #:
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| 118
|
|
|
|
|
| LET
13884
|
| Omnilife Manufactura,S.A. de C.V.
|
| Vol #:
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| 118
|
|
|
|
|
| LET
13885
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 118
|
|
|
|
|
| LET
13886
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 118
|
|
|
|
|
| LET
13887
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 118
|
|
|
|
|
| LET
13888
|
| MT Sales (U.S.), Inc.
|
| Vol #:
|
| 118
|
|
|
|
|
| LET
13889
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 118
|
|
|
|
|
| LET
13890
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 118
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| EMC 373
|
| K. Johnson
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
|
|
|
| EMC 372
|
| K. Johnson
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| EMC 375
|
| K. Johnson
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999V-1717
|
| Laser Light Show
|
|
|
|
|
| VRA
3
|
| HFZ-300 to Laser Show Design, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2000D-1350
|
| Combined Oral Contraceptives/Labeling/Healthcare Providers
|
|
|
|
|
| C
15
|
| Reproductive Health Technologics Project
|
| Vol #:
|
| 6
|
|
|
|
|
| C
16
|
| The Alan Guttmacher Institute
|
| Vol #:
|
| 6
|
|
|
|
|
| C
17
|
| Ibis Reproductive Health
|
| Vol #:
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| 6
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EMC 738
|
| J Pchelka
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 739
|
| Jim & Prem Purtle
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 740
|
| Peter Loeff
|
| Vol #:
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| 271
|
|
|
|
|
| EMC 741
|
| Neil Boccanfuso
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 742
|
| Judy Hundley
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 743
|
| Anne Carter
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 744
|
| Carlos Vazquez
|
| Vol #:
|
| 271
|
|
|
|
|
| EXB 25
|
| CVM
|
| Vol #:
|
| 403
|
|
|
|
|
| EXB 26
|
| CVM
|
| Vol #:
|
| 403
|
|
|
|
|
| EXB 27
|
| CVM
|
| Vol #:
|
| 403
|
|
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
|
| EMC 477
|
| K. Johnson
|
| Vol #:
|
| 8
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 1348
|
| D. McCants
|
| Vol #:
|
| 209
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1233
|
| M. Tumbok
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C
295
|
| J&K Fresh, LLC
|
| Vol #:
|
| 22
|
|
|
|
|
| EXT
1
|
| Goverment of Canada
|
| Vol #:
|
| 22
|
|
|
|
|
| 2002P-0245
|
| ANDA for Fludarabine Phosphate Injection, 25 mg/ML
|
|
| | | | | | | | |
|
|
|
|
| LET
2
|
| HFD-600 to Gensia Sicor Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002P-0414
|
| Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA
|
|
|
|
|
| PDN
1
|
| HFD-600 to The Weinberg Group, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0367
|
| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
|
|
|
|
|
| C
6
|
| LEO Pharma
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| CS
5
|
| HFA-305 to Henry E. Schwartz LLC
|
| Vol #:
|
| 2
|
|
|
|
|
| OR
5
|
| HF-3
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 174
|
| B and E Pretzer
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 175
|
| P. Moscovich
|
| Vol #:
|
| 7
|
|
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
|
|
| EMC 226
|
| K. Prior
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0211
|
| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
|
|
|
|
|
| C 13
|
| J. Carle
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0324B
|
| Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
|
|
|
|
|
| LET
2
|
| Honorable Lee Terry
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
3
|
| Honorable Elizabeth Dole et al
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0324O
|
| Oxytetracycline and neomycin fixed-combination Type A medicated articles
|
|
|
|
|
| LET
2
|
| Honorable Lee Terry
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
3
|
| Honorable Elizabeth Dole et al.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| LET
4
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| C 71
|
| H. Golly
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
|
|
| LET
4
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
|
| EMC 21
|
| L. Goddard
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
|
|
| C
6
|
| Breast Cancer Action
|
| Vol #:
|
| 1
|
|
|
|
|
| C
7
|
| Contact Lens Institute
|
| Vol #:
|
| 1
|
|
|
|
|
| C 8
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0117
|
| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
|
|
|
|
|
| C
1
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0160
|
| Use of Unapproved Hormone Implants in Veal Calves
|
|
|
|
|
| C
1
|
| The Humane Society of the United States (HSUS)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
|
|
|
| C
1
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0087
|
| Request for Comment on Generic Drug Issues
|
|
|
|
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| C
1
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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|
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|
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| C
2
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| Sandoz, Inc.
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| Vol #:
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| 1
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| C
3
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| Apotex Corp. (Apotex)
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| Vol #:
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| 1
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|
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| C
4
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 1
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|
|
| 2004N-0115
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| Prescription Drug Importation Study
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|
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|
|
| TR
2
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| HHS Importation Task Force Public Meeting held on April 14, 2004
|
| Vol #:
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| 6
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|
|
|
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| TR
3
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| Importation Task Force Public Meeting held on April 14, 2004
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| Vol #:
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| 7
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|
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|
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| 2004P-0208
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| ANDA Suitability for Glipizide and Metformin HCl Tablets for Oral Suspension
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|
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| ACK 1
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| HFA-305 to The Weinberg Group Inc.
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| Vol #:
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| 1
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|
|
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| CP
1
Attachment 1,
2
|
| The Weinberg Group Inc.
|
| Vol #:
|
| 1
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|
|
|
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| 2004P-0209
|
| ANDA Suitability for Glyburide and Metformin HCl Tablets for Oral Suspension
|
|
|
|
|
| ACK 1
|
| HFA-305 to the Weinberg Group Inc.
|
| Vol #:
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| 1
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|
|
|
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| CP
1
Attachment 1,
2
|
| The Weinberg Group
|
| Vol #:
|
| 1
|
|
|
|
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| 2004V-0135
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| Laser Light Show
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|
|
|
|
| VRA
1
|
| HFZ-300 to NECA/IBEW Local Union #159 LMCCTrust
|
| Vol #:
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| 1
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