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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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| 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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| 1976N-0098
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| Physiologic Dependence, staffing & Urine Test Req-Methado
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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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| 1977N-0009
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| FD&C Yellow No. 5
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| 1977N-0033
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| Brown & Yellow Mustard and Their Derivatives
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| 1977N-0078
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| Acrylonitrile Copolymers; Contact with Food
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| 1977N-0232
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| Gelatin; GRAS Status as Direct Human Food Ingredient
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| 1977N-0318
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| Penicillin & Tetracycline and all Combinations
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| 1977N-0424
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| Maximum Residue Limits for Ethylene Oxide et al
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| 1977P-0146
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| Food; Designation of Ingred. Class Name for Cheese Cultur
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| 1978N-0072
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| FOOD CHEMICALS CODEX MONOGRAPHS
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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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| 1978N-0247
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| CHLORTETRACYCLINE-SULFAMETHAZINE TABLETS
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| 1978N-0272
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| PHOSPHATES
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| 1978N-0308
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| Biotin
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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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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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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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| 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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| 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
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| 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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| | | | | | | | |
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| 1975N-0069
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| RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS
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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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| 1975N-0125
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| CONDITIONS FOR USE OF METHADONE
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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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| 1975N-0243
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| Pasteurized Milk Ordinance and Interstate Milk Shippers
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| NWL
1
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| FDA
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| Vol #:
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| 5
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| 1976N-0098
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| Physiologic Dependence, staffing & Urine Test Req-Methado
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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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| 1977G-0379
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| Sorbic Acid & Its Salts
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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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| 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
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| 1977N-0009
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| FD&C Yellow No. 5
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| NWL
1
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| FDA
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| Vol #:
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| 7
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| 1977N-0033
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| Brown & Yellow Mustard and Their Derivatives
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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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| 1977N-0078
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| Acrylonitrile Copolymers; Contact with Food
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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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| 1977N-0232
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| Gelatin; GRAS Status as Direct Human Food Ingredient
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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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| 1977N-0318
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| Penicillin & Tetracycline and all Combinations
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| NWL
1
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| FDA
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| Vol #:
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| 40
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| 1977N-0424
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| Maximum Residue Limits for Ethylene Oxide et al
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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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| 1977P-0146
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| Food; Designation of Ingred. Class Name for Cheese Cultur
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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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| 1978N-0072
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| FOOD CHEMICALS CODEX MONOGRAPHS
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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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| 1978N-0144
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| Cellulose Derivatives
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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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| 1978N-0213
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| Tocopherols & Derivatives
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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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| 1978N-0247
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| CHLORTETRACYCLINE-SULFAMETHAZINE TABLETS
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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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| 1978N-0272
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| PHOSPHATES
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| NWL
1
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| FDA
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| Vol #:
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| 3
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| 1978N-0308
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| Biotin
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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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| 1978N-0336
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| Lard and Lard Oil
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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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| 1978P-0164
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| AMEND SEC. 101.22, ESTAB. UNIFORM FORMAT FOR LABEL DECLAR
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|
|
|
|
| NWL
1
|
| FDA
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| Vol #:
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| 1
|
|
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| ACK 3
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| number not used
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| Vol #:
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| 1
|
|
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| ACK
4
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| HFA-305 to International Dairy Foods Association
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| Vol #:
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| 84
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| PSA
1
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| International Dairy Foods Association
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| Vol #:
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| 84
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| EMC 9
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| B. Sachau
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| Vol #:
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| 7
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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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| EMC 9
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| B. Sachau
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| Vol #:
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| 9
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 561
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| No signature
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| Vol #:
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| 24
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| EMC 562
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| S. Richey
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| Vol #:
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| 24
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 803
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| Mr and Mrs P. Rheaume
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| Vol #:
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| 33
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| 2000N-0504
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| Egg Safety Action Plan
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| EMC 568
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| R. Eures
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| Vol #:
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| 17
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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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| EMC 11609
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| L. Choate
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| Vol #:
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| 299
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| EMC 11610
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| A. Nichols
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| Vol #:
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| 299
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| EMC 11611
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| M. Swanson
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| Vol #:
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| 299
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| EMC 11612
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| S. Iyer
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| Vol #:
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| 299
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| EMC 11613
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| W. Oser
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| Vol #:
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| 299
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| EMC 11614
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| W. Oser
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| Vol #:
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| 299
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| EMC 11615
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| S. Jones
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| Vol #:
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| 299
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| EMC 11616
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| S. Bachman
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| Vol #:
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| 299
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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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| CR
1
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| HFD-7 to Rothwell, Figg, Ernst & Manbeck, PC (Mylan Pharmaceuticals Inc)
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| Vol #:
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| 3
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|
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| MO
9
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| Korangy Radiology Associates, P.A., et al
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| Vol #:
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| 6
|
|
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| 2004M-0533
|
| P040002 - Endologix PowerLink System
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| AAV
1
|
| Endologix, Inc.
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| Vol #:
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| 1
|
|
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|
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| 2004M-0538
|
| Premarket Approval for Bayer Diagnostics Bayer Versant HCV RNA 3.0 Assay (bDNA)
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|
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| AAV
1
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| Bayer Diagnostics
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| Vol #:
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| 1
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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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| C
2
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| Council for Responsible Nutrition (CRN)
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| Vol #:
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| 3
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| C
3
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| Miami Research Associates
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| Vol #:
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| 3
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| EC 57
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| Collins, McDonald
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| Vol #:
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| 1
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| EC
58
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| Diverstech Co.
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| Vol #:
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| 1
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| EC
59
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| simply fit personal training llc
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| Vol #:
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| 1
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| EC 60
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| Mr. Reid L. Vaspol
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| Vol #:
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| 1
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| EC 61
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| Mr. Ray Foreman
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| Vol #:
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| 1
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| EC
62
Attachment
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| Council for Responsible Nutrition
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| |
