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| Dockets Entered
On December 8, 2004
Table of Contents
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| Docket #
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| Title
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| 1975N-0069
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| RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS
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| |
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| 1975N-0125
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| CONDITIONS FOR USE OF METHADONE
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| |
|
|
| 1975N-0243
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| Pasteurized Milk Ordinance and Interstate Milk Shippers
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| |
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|
| 1976N-0098
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| Physiologic Dependence, staffing & Urine Test Req-Methado
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| |
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| 1977G-0379
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| Sorbic Acid & Its Salts
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| 1977N-0003
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| Butylated Hydroxytoluene
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| |
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| 1977N-0009
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| FD&C Yellow No. 5
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| |
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| 1977N-0033
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| Brown & Yellow Mustard and Their Derivatives
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| |
|
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| 1977N-0078
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| Acrylonitrile Copolymers; Contact with Food
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| |
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| 1977N-0232
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| Gelatin; GRAS Status as Direct Human Food Ingredient
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| |
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| 1977N-0318
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| Penicillin & Tetracycline and all Combinations
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| |
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| 1977N-0424
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| Maximum Residue Limits for Ethylene Oxide et al
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| |
|
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| 1977P-0146
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| Food; Designation of Ingred. Class Name for Cheese Cultur
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| |
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| 1978N-0072
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| FOOD CHEMICALS CODEX MONOGRAPHS
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| |
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| 1978N-0144
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| Cellulose Derivatives
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| |
|
|
| 1978N-0213
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| Tocopherols & Derivatives
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| |
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|
| 1978N-0247
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| CHLORTETRACYCLINE-SULFAMETHAZINE TABLETS
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| |
|
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| 1978N-0272
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| PHOSPHATES
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| |
|
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| 1978N-0308
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| Biotin
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| |
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|
| 1978N-0336
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| Lard and Lard Oil
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| |
|
|
| 1978P-0164
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| AMEND SEC. 101.22, ESTAB. UNIFORM FORMAT FOR LABEL DECLAR
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| |
|
|
| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| |
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|
| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| |
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| |
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| 2000N-0504
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| Egg Safety Action Plan
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| |
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|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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|
| 2001P-0529
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| Request that '365 Patent Not be Re-listed in Orange Book
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| |
|
|
| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2004M-0533
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| P040002 - Endologix PowerLink System
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| |
|
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| 2004M-0538
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| Premarket Approval for Bayer Diagnostics Bayer Versant HCV RNA 3.0 Assay (bDNA)
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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|
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| 2004P-0168
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| ANDA Suitability for Glipizide and Metformin Hydrochloride Oral Solution
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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
|
| ANDA Suitability for Glyburide and Metformin HCl Tablets for Oral Suspension
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| |
|
|
| 2004P-0321
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| ANDA For Benzonatate Capsules USP, 150 mg
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| | | | | | | | |
| |
|
|
| 1975N-0069
|
| RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS
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| |
|
|
| NWL
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1975N-0125
|
| CONDITIONS FOR USE OF METHADONE
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| |
|
|
| NWL
1
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| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1975N-0243
|
| Pasteurized Milk Ordinance and Interstate Milk Shippers
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 5
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| |
|
|
| 1976N-0098
|
| Physiologic Dependence, staffing & Urine Test Req-Methado
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1977G-0379
|
| Sorbic Acid & Its Salts
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
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| |
|
|
| 1977N-0003
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| Butylated Hydroxytoluene
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| |
|
|
| NWL
1
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| FDA
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| Vol #:
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| 1
|
| |
|
|
| 1977N-0009
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| FD&C Yellow No. 5
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 7
|
| |
|
|
| 1977N-0033
|
| Brown & Yellow Mustard and Their Derivatives
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1977N-0078
|
| Acrylonitrile Copolymers; Contact with Food
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1977N-0232
|
| Gelatin; GRAS Status as Direct Human Food Ingredient
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1977N-0318
|
| Penicillin & Tetracycline and all Combinations
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 40
|
| |
|
|
| 1977N-0424
|
| Maximum Residue Limits for Ethylene Oxide et al
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1977P-0146
|
| Food; Designation of Ingred. Class Name for Cheese Cultur
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1978N-0072
|
| FOOD CHEMICALS CODEX MONOGRAPHS
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
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| |
|
|
| 1978N-0144
|
| Cellulose Derivatives
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|
| | | | | | | | |
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1978N-0213
|
| Tocopherols & Derivatives
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1978N-0247
|
| CHLORTETRACYCLINE-SULFAMETHAZINE TABLETS
|
| |
|
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| NWL
1
|
| FDA
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| Vol #:
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| 1
|
| |
|
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| 1978N-0272
|
| PHOSPHATES
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| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
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| 3
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| |
|
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| 1978N-0308
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| Biotin
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| |
|
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| |
|
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| 1978N-0336
|
| Lard and Lard Oil
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1978P-0164
|
| AMEND SEC. 101.22, ESTAB. UNIFORM FORMAT FOR LABEL DECLAR
|
| |
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1994P-0036
|
| Req labeling of trans fatty acid & prohibit deceptive claims
|
| |
|
|
| ACK 3
|
| number not used
|
| Vol #:
|
| 1
|
| |
|
|
| ACK
4
|
| HFA-305 to International Dairy Foods Association
|
| Vol #:
|
| 84
|
| |
|
|
| PSA
1
|
| International Dairy Foods Association
|
| Vol #:
|
| 84
|
| |
|
|
| 1994P-0390
|
| Adopt Amendments Governing Health Claims & Nutrient Claims
|
| |
|
|
| EMC 9
|
| B. Sachau
|
| Vol #:
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| 7
|
| |
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
| |
|
|
| EMC 9
|
| B. Sachau
|
| Vol #:
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| 9
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 561
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| No signature
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| Vol #:
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| 24
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| |
|
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| EMC 562
|
| S. Richey
|
| Vol #:
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| 24
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 803
|
| Mr and Mrs P. Rheaume
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| Vol #:
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| 33
|
| |
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
| |
|
|
| EMC 568
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| R. Eures
|
| Vol #:
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| 17
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| |
|
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| EMC 569
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| K. Lange
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| Vol #:
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| 17
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| | | | | | | |
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| EMC 570
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| T. Seward
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| Vol #:
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| 17
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| |
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| EMC 571
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| S. DeSmedt
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| Vol #:
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| 17
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| |
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| EMC 572
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| A. Carter
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| Vol #:
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| 17
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| |
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| EMC 573
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| Dr and Mrs J. Argyle
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| Vol #:
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| 17
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| |
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| EMC 574
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| D. Steinberg
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| Vol #:
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| 17
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| |
|
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| EMC 575
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| No signature
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| Vol #:
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| 17
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| |
|
|
| EMC 576
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| D. Bolbol
|
| Vol #:
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| 17
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| |
|
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| EMC 577
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| E. Helford, PhD
|
| Vol #:
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| 17
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| |
|
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| EMC 578
|
| T. Knight
|
| Vol #:
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| 17
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| |
|
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| EMC 579
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| S. DeGroff
|
| Vol #:
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| 17
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| |
|
|
| EMC 580
|
| C. Anderson
|
| Vol #:
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| 17
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| |
|
|
| EMC 581
|
| S. Wagner
|
| Vol #:
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| 17
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| |
|
|
| EMC 582
|
| J. Lewis
|
| Vol #:
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| 17
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| |
|
|
| EMC 583
|
| R. Artley
|
| Vol #:
|
| 17
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| |
|
|
| EMC 584
|
| No signature
|
| Vol #:
|
| 17
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| |
|
|
| EMC 585
|
| J. Johnson
|
| Vol #:
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| 17
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| |
|
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| EMC 586
|
| L. Hauptman
|
| Vol #:
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| 17
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| |
|
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| EMC 587
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| T. Green
|
| Vol #:
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| 17
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| |
|
|
| EMC 588
|
| N. Dunkel
|
| Vol #:
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| 17
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| |
|
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| EMC 589
|
| D. Clark
|
| Vol #:
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| 17
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| |
|
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| EMC 590
|
| A. Stevens
|
| Vol #:
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| 17
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| |
|
|
| EMC 591
|
| Deanna Trietsch
|
| Vol #:
|
| 17
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| |
|
|
| EMC 592
|
| S. Rowland
|
| Vol #:
|
| 17
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| |
|
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| EMC 593
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| K. Newman
|
| Vol #:
|
| 17
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| |
|
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| EMC 594
|
| K. Sommers
|
| Vol #:
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| 17
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| |
|
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| EMC 595
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| K. Lom
|
| Vol #:
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| 17
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| |
|
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| EMC 596
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| K. Lom
|
| Vol #:
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| 17
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| |
|
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| EMC 597
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| D. Railey
|
| Vol #:
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| 17
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| |
|
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| EMC 598
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| J. McLean
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| Vol #:
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| 17
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| |
|
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| EMC 599
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| S. Grogan
|
| Vol #:
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| 17
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| |
|
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| EMC 600
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| M. Alford
|
| Vol #:
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| 17
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| |
|
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| EMC 601
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| K. Spaldi
|
| Vol #:
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| 17
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| |
|
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| EMC 602
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| S. Nemour
|
| Vol #:
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| 17
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| |
|
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| EMC 603
|
| G. Sweeney
|
| Vol #:
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| 17
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| |
|
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| EMC 604
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| D. Lenhart
|
| Vol #:
|
| 17
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| |
|
|
| EMC 605
|
| A. Griswold
|
| Vol #:
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| 17
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| |
|
|
| EMC 606
|
| J. Hickman
|
| Vol #:
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| 17
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|
| | | | | | | |
| |
|
|
| EMC 607
|
| No signature
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 608
|
| No signature
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 609
|
| M. Engebretson
|
| Vol #:
|
| 17
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| |
|
|
| EMC 610
|
| R. Freedman
|
| Vol #:
|
| 17
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| |
|
|
| EMC 611
|
| D. Cray
|
| Vol #:
|
| 17
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| |
|
|
| EMC 612
|
| G. Richardson
|
| Vol #:
|
| 17
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| |
|
|
| EMC 613
|
| B. Redgrift
|
| Vol #:
|
| 17
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| |
|
|
| EMC 614
|
| E. Til
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 615
|
| B. Imam
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 616
|
| J. Rubenstein
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 617
|
| S. Dzienius
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 618
|
| B. Auge
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 619
|
| E. Driscoll
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 620
|
| J. Weston
|
| Vol #:
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| 17
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| |
|
|
| EMC 621
|
| H. Frank
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 622
|
| B. Warner
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 623
|
| K. Lazur
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 624
|
| L. Mancini
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 625
|
| L. Mancini
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 626
|
| B. Stuff
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 627
|
| M. Carnes, RN
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 628
|
| J. Nobley
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 629
|
| S. Johnston
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 630
|
| L. Silverman
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 631
|
| M. Gupta
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 632
|
| Dr. L. Spears
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 633
|
| G. Meads
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 634
|
| D. Scott
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 635
|
| N. Lents
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 636
|
| S. McLath
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 637
|
| U. Pelka
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 638
|
| V. Robertson
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 639
|
| K. Crupi
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 640
|
| J. Ellis
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 641
|
| P. Lecht
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 642
|
| B. Brownstein
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 643
|
| M. Martucci
|
| Vol #:
|
| 17
|
|
| | | | | | | | |
| |
|
|
| EMC 644
|
| A. McAuliffe
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 645
|
| N. Martindale
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 646
|
| V. Frasco
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 647
|
| S. Gunning
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 648
|
| M. Moneypenny
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 649
|
| C. Brownholtz
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 650
|
| M and D Reeves
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 651
|
| S. Kimball
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 652
|
| C. Hamlin
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 653
|
| N. Heagney
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 654
|
| L. Smilestone
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 655
|
| M and P Max
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 656
|
| M. Carter
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 657
|
| K. Campo
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 658
|
| Dr. L. Iyer
|
| Vol #:
|
| 17
|
| |
|
|
| EMC
659
|
| Cal-Maine Foods, Inc.
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 660
|
| T. Ewing
|
| Vol #:
|
| 17
|
| |
|
|
| EMC 661
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| No signature
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| Vol #:
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| 17
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| |
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| EMC 662
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| M. Casson
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| Vol #:
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| 17
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| EMC 663
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| C. Snyder
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| Vol #:
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| 17
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| EMC 664
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| B. Kwasnik
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| Vol #:
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| 17
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| EMC 665
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| S. Fraley Paddock
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| Vol #:
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| 17
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| EMC 666
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| S. Ellis
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| Vol #:
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| 17
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| EMC 667
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| Dr. L Pesteanu
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| Vol #:
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| 17
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| EMC 668
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| S. Miner
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| Vol #:
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| 17
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| EMC 669
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| N. Marino, Esq
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| 17
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| |
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| EMC 670
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| No signature
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| Vol #:
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| 17
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 11453
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| Form Letter
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| Vol #:
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| 298
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| EMC 11454
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| D. Wells
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| Vol #:
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| 296
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| EMC 11455
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| C. Quackenboss
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| EMC 11456
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| M. Cashwell
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| EMC 11457
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| B. Reeves
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| 296
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| EMC 11458
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| D. Whitecar
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| Vol #:
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| EMC 11459
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| J. Sipovic
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| EMC 11460
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| E. Trosper
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| Vol #:
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| 296
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| EMC 11461
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| J. Lloyd
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| Vol #:
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| 296
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| EMC 11462
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| L. Petriello
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| Vol #:
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| 296
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| EMC 11463
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| A. Allen
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| Vol #:
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| 296
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| EMC 11464
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| L. Darrah
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| EMC 11465
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| A. Chateau
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| 296
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| EMC 11466
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| E. Horvath
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| Vol #:
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| 296
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| EMC 11467
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| O. Exum
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| Vol #:
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| 296
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| EMC 11468
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| S. Flemming
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| 296
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| EMC 11469
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| G. Harris
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| 296
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| EMC 11470
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| K. Jenkins
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| 296
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| EMC 11471
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| C. Stiles
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| Vol #:
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| 296
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| EMC 11472
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| J. Davis
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| 296
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| EMC 11473
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| M. Silpa
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| Vol #:
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| 296
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| EMC 11474
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| B. Crawford
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| Vol #:
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| 296
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| EMC 11475
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| M. Thompson
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| Vol #:
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| 296
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| EMC 11476
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| C. Fuortes
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| Vol #:
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| 296
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| EMC 11477
|
| A. Myers
|
| Vol #:
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| 296
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| EMC 11478
|
| S. Solly
|
| Vol #:
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| 296
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| EMC 11479
|
| A. Andrews
|
| Vol #:
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| 296
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| EMC 11480
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| L. McLaughlin
|
| Vol #:
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| 296
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| EMC 11481
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| J. Turcotte
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| Vol #:
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| 296
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| EMC 11482
|
| K. Filippi
|
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| 296
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| EMC 11483
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| L. Gorton
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| 296
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| EMC 11484
|
| D. Yukus
|
| Vol #:
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| 296
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| EMC 11485
|
| S. Getz
|
| Vol #:
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| 296
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|
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| EMC 11486
|
| E. Mahaney
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| Vol #:
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| 296
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| EMC 11487
|
| K. Gemmer
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| Vol #:
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| 296
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| EMC 11488
|
| J. Virgo
|
| Vol #:
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| 296
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| EMC 11489
|
| K. Williams
|
| Vol #:
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| 296
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| EMC 11490
|
| K. Colavita
|
| Vol #:
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| 296
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| |
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|
| EMC 11491
|
| L. Drizd
|
| Vol #:
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| 296
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| |
|
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| EMC 11492
|
| S. Parsons
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| Vol #:
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| 296
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| |
|
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| EMC 11493
|
| M. Lichterman
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11494
|
| K. Burke
|
| Vol #:
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| 296
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| |
|
|
| EMC 11495
|
| C. Schwartz
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11496
|
| P. Mastrangelo
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11497
|
| L. Rosen
|
| Vol #:
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| 296
|
|
| | | | | | | |
| |
|
|
| EMC 11498
|
| K. McAuley
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11499
|
| L. Cardella
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11500
|
| C. Schuetze
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11501
|
| E. Carter
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11502
|
| A. Burnham
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11503
|
| S. Doucha
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11504
|
| M. Conner
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11505
|
| R. Schmidt
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11506
|
| M. McClellan
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11507
|
| J. Kirchen
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11508
|
| F. Mihalic
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11509
|
| R. Fogletto
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11510
|
| J. Andersen
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11511
|
| L. Wartenberg
|
| Vol #:
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| 296
|
| |
|
|
| EMC 11512
|
| D. Poulin
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11513
|
| M. Gomez
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11514
|
| E. Wisely
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11515
|
| E. Williams
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11516
|
| A. Dudley
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11517
|
| J. Stein
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11518
|
| S. Perez
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11519
|
| M. Heath
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11520
|
| S. Saeed
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11521
|
| M. Wallner
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11522
|
| M. Wallner
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11523
|
| M. Wallner
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11524
|
| M. Wallner
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11525
|
| M. Ferretti
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11526
|
| K. Wochinger
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11527
|
| P. Wilson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11528
|
| K. Beggs
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11529
|
| V. Halsall
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11530
|
| M. Dawson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11531
|
| H. Stevenson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11532
|
| K. Dixon
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11533
|
| R. Mungaray
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11534
|
| J. Scott
|
| Vol #:
|
| 296
|
|
| | | | | | | |
| |
|
|
| EMC 11535
|
| E. Storm
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11536
|
| T. Hersha
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11537
|
| K. Roland
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11538
|
| K. Roland
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11539
|
| L. Lahr
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11540
|
| R. Brimstin
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11541
|
| H. Herrick
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11542
|
| S. Trapnell
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11543
|
| L. Polinski
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11544
|
| L. Leckert
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11545
|
| M. Lord
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11546
|
| K. Daly
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11547
|
| J. Smith
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11548
|
| A. Lackman
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11549
|
| C. Green
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11550
|
| A. Lacorazza
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11551
|
| N. Maas
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11552
|
| K. Kath
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11553
|
| P. Hopkins
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11554
|
| J. Hart
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11555
|
| S. Renninger
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11556
|
| J. Creel
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11557
|
| G. Boone
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11558
|
| P. Stakelon
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11559
|
| S. Cassidy
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11560
|
| S. Brown
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11561
|
| K. Griffin
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11562
|
| S. Phillips
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11563
|
| S. Alexander
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11564
|
| E. Seitz
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11565
|
| C. Cooper
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11566
|
| E. Barton
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11567
|
| M. Tutko
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11568
|
| S. Lai
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11569
|
| A. Nickelson
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11570
|
| D. Pepe
|
| Vol #:
|
| 269
|
| |
|
|
| EMC 11571
|
| M. Campbell
|
| Vol #:
|
| 296
|
|
| | | | | | | |
| |
|
|
| EMC 11572
|
| A. Epstein
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11573
|
| J. Innerarity
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11574
|
| P. Webb
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11575
|
| C. Sniffen
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11576
|
| K. Brooks
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11577
|
| A. Muniz
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11578
|
| T. Wilhelm
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11579
|
| A. Foucek
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11580
|
| C. Smith
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11581
|
| M. Mendenhall
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11582
|
| L. Blue
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11583
|
| T. Rooney
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11584
|
| C. Brand, M.D.
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11585
|
| E. Kamin
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11586
|
| E. Biondi
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11587
|
| J. Shaw
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11588
|
| A. Bouman
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11589
|
| D. Griffel
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11590
|
| R. Pahcholy
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11591
|
| E. Conger
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11592
|
| J. Batanavl
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11593
|
| T. Pattinger
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11594
|
| A. Wise
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11595
|
| L. Mason
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11596
|
| A. Pazmino
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11597
|
| A. Khan
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11598
|
| P. Sinha
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11599
|
| B. Pazmino
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11600
|
| K. Nastawa
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11601
|
| C. Darby
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11602
|
| C. Hammel
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11603
|
| S. Grossman
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11604
|
| C. Owens
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11605
|
| J. Buna
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 11606
|
| J. Giuling
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11607
|
| J. Midgette
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11608
|
| C. Reece
|
| Vol #:
|
| 296
|
|
| | | | | | | | |
| |
|
|
| EMC 11609
|
| L. Choate
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11610
|
| A. Nichols
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11611
|
| M. Swanson
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11612
|
| S. Iyer
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11613
|
| W. Oser
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11614
|
| W. Oser
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11615
|
| S. Jones
|
| Vol #:
|
| 299
|
| |
|
|
| EMC 11616
|
| S. Bachman
|
| Vol #:
|
| 299
|
| |
|
|
| 2001P-0529
|
| Request that '365 Patent Not be Re-listed in Orange Book
|
| |
|
|
| CR
1
|
| HFD-7 to Rothwell, Figg, Ernst & Manbeck, PC (Mylan Pharmaceuticals Inc)
|
| Vol #:
|
| 3
|
| |
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
| |
|
|
| MO
9
|
| Korangy Radiology Associates, P.A., et al
|
| Vol #:
|
| 6
|
| |
|
|
| 2004M-0533
|
| P040002 - Endologix PowerLink System
|
| |
|
|
| AAV
1
|
| Endologix, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0538
|
| Premarket Approval for Bayer Diagnostics Bayer Versant HCV RNA 3.0 Assay (bDNA)
|
| |
|
|
| AAV
1
|
| Bayer Diagnostics
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| C
2
|
| Council for Responsible Nutrition (CRN)
|
| Vol #:
|
| 3
|
| |
|
|
| C
3
|
| Miami Research Associates
|
| Vol #:
|
| 3
|
| |
|
|
| EC 57
|
| Collins, McDonald
|
| Vol #:
|
| 1
|
| |
|
|
| EC
58
|
| Diverstech Co.
|
| Vol #:
|
| 1
|
| |
|
|
| EC
59
|
| simply fit personal training llc
|
| Vol #:
|
| 1
|
| |
|
|
| EC 60
|
| Mr. Reid L. Vaspol
|
| Vol #:
|
| 1
|
| |
|
|
| EC 61
|
| Mr. Ray Foreman
|
| Vol #:
|
| 1
|
| |
|
|
| EC
62
Attachment
|
| Council for Responsible Nutrition
|
| Vol #:
|
| 1
|
| |
|
|
| EC 63
|
| Mr. Charles Waugh
|
| Vol #:
|
| 1
|
| |
|
|
| EC
64
|
| Amer Soc for Clinical Pharmacology
|
| Vol #:
|
| 3
|
| |
|
|
| EC 65
|
| Miss. abigail rolfe
|
| Vol #:
|
| 3
|
| |
|
|
| EC
66
|
| The American Dietetic Association
|
| Vol #:
|
| 3
|
| |
|
|
| EC
67
|
| ZeaVision LLC
|
| Vol #:
|
| 3
|
| |
|
|
| LST
1
|
| Agenda for November 15, 2004 meeting
|
| Vol #:
|
| 3
|
| |
|
|
| LST
2
|
| List of participants, attendees
|
| Vol #:
|
| 3
|
| |
|
|
| TR
1
|
| Transcript of November 15, 2004 Public Meeting
|
| Vol #:
|
| 2
|
| |
|
|
| TS
1
|
| Director, Division of Dietary Supplement Programs, FDA
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| TS
2
|
| American Herbal Products Association
|
| Vol #:
|
| 1
|
| |
|
|
| TS
3
|
| Council for Responsible Nutrition (CRN)
|
| Vol #:
|
| 3
|
| |
|
|
| TS
4
|
| Consumer Health Products Association, Council for Resonsible Nutrition
|
| Vol #:
|
| 3
|
| |
|
|
| TS
5
|
| National Nutritional Foods Association
|
| Vol #:
|
| 3
|
| |
|
|
| TS
6
|
| Collins, McDonald, & Gann PC
|
| Vol #:
|
| 3
|
| |
|
|
| TS
7
|
| George A Burdock PhD
|
| Vol #:
|
| 3
|
| |
|
|
| TS
8
|
| Hyman Phelps & McNamara PC
|
| Vol #:
|
| 3
|
| |
|
|
| TS
9
|
| Hyman Phelps & McNamara PC
|
| Vol #:
|
| 3
|
| |
|
|
| TS
10
|
| Humanetics Corporation
|
| Vol #:
|
| 3
|
| |
|
|
| TS
11
|
| Pharmavite LLC
|
| Vol #:
|
| 3
|
| |
|
|
| TS
12
|
| Will Hunziker DVM MBA
|
| Vol #:
|
| 3
|
| |
|
|
| 2004P-0168
|
| ANDA Suitability for Glipizide and Metformin Hydrochloride Oral Solution
|
| |
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0208
|
| ANDA Suitability for Glipizide and Metformin HCl Tablets for Oral Suspension
|
| |
|
|
| PAV
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0209
|
| ANDA Suitability for Glyburide and Metformin HCl Tablets for Oral Suspension
|
| |
|
|
| PAV
1
|
| HFD-600 to The Weinberg Group Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0321
|
| ANDA For Benzonatate Capsules USP, 150 mg
|
| |
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc`
|
| Vol #:
|
| 1
|
|
|
