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| Dockets Entered
On March 2, 2006
Table of Contents
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| Docket #
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| Title
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1978N-0036L
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| OTC Laxative
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001C-0486
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| Tomato lycopene extract to color foods generally
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0206
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| No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| 2004P-0348
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| ANDA for Fluticasone Propionate Nasal Spray, 50 mcg
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| 2004P-0452
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| Regulate the use of coding on food labels
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| 2005E-0254
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| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0393
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
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| 2005N-0510
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| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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| 2005P-0376
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| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0432
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| Ban all Non-medical Uses of the Antibacterial Agent Triclosan
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| 2005P-0460
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| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
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| 2005P-0464
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| Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance
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| 2005P-0472
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| ANDA for Ramipril Instant Release Oral Tablets
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| 2005V-0499
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| Laser Pointer/Illuminator products GCP-1A. GCP-2
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006P-0093
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| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
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| 2006P-0094
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| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
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| 2006Q-0091
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| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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|
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| SUP
13
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| Ciba Specialty Chemicals Corporation (Ciba)
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| Vol #:
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| 202
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|
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| 1978N-0036L
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| OTC Laxative
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| | | | | | | | |
|
|
| LET
204
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| C.B. Fleet Company, Inc. (Fleet)
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| Vol #:
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| 138
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|
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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|
|
| C
8
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| Johanna Foods, Inc. (JF
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| Vol #:
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| 1
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|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18253
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| A. Chait
|
| Vol #:
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| 516
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|
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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|
|
| C 12846
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| A. Chait
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| Vol #:
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| 806
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|
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| 2001C-0486
|
| Tomato lycopene extract to color foods generally
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|
|
| NFR
2
|
| FDA
|
| Vol #:
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| 1
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| C 1368
|
| A. Chait
|
| Vol #:
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| 259
|
|
|
| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
| GDL
2
|
| GUIDANCE
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| Vol #:
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| 1
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|
|
| NAD
2
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| FDA
|
| Vol #:
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| 1
|
|
|
| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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|
|
| C
6
|
| Hyman, Phelps & McNamara, P.C.
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| Vol #:
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| 1
|
|
|
| 2004P-0206
|
| No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
|
|
|
| REF
1
|
| References
|
| Vol #:
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| 3
|
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
|
|
| C
29
|
| Whole Grains Council
|
| Vol #:
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| 5
|
|
|
| LET
5
|
| HFS-820 to Whole Grains Council
|
| Vol #:
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| 5
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
| REF
1
|
| References
|
| Vol #:
|
| 3
|
|
|
| 2004P-0348
|
| ANDA for Fluticasone Propionate Nasal Spray, 50 mcg
|
|
|
| REF
1
|
| References
|
| Vol #:
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| 2
|
|
|
| 2004P-0452
|
| Regulate the use of coding on food labels
|
|
|
| LET
3
|
| HFS-820 to Bunny Abraham
|
| Vol #:
|
| 1
|
|
|
| 2004P-0523
|
| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
|
|
|
| REF
1
|
| References
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| 2005E-0254
|
| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
|
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
| C
10
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| Sanofi-aventis US, Inc.
|
| Vol #:
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| 4
|
|
|
| C 11
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| D. Rubis
|
| Vol #:
|
| 4
|
|
|
| 2005N-0393
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
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|
|
| N
2
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| FDA
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| Vol #:
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| 1
|
|
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| 2005N-0510
|
| Anti-Counterfeit Drug Initiative Workshop and Vendor Display
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|
|
| C
5
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| Baxter Healthcare Corporation (Baxter)
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| Vol #:
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| 2
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|
|
| C
6
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 2
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|
|
| C
7
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| Alcon Research, Ltd (Alcon)
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| Vol #:
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| 2
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|
|
| C
8
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| CVS/pharmacy
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| Vol #:
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| 2
|
|
|
| 2005P-0376
|
| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
|
|
|
| LET
3
|
| HFS-822 to Rutan & Tucker, LLP
|
| Vol #:
|
| 1
|
|
|
| 2005P-0383
|
| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
|
|
|
| C
2
|
| Hyman, Phelps & McNamara, P.C.
|
| Vol #:
|
| 1
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 1351
|
| N. Fehr
|
| Vol #:
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| 27
|
|
|
| C 1352
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| M. Magel
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| Vol #:
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| 27
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|
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| C 1353
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| D. Brown
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| Vol #:
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| 27
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|
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| C 1354
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| B. Wagner
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| Vol #:
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| 27
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|
|
| C 1355
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| A. Martin
|
| Vol #:
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| 27
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|
|
| C 1356
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| H. Joshua
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| Vol #:
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| 27
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|
|
| C 1357
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| Z. Davis
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| Vol #:
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| 27
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|
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| C 1358
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| A. Kolejka
|
| Vol #:
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| 27
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|
|
| C 1359
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| M. Vancini
|
| Vol #:
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| 27
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|
|
| C 1360
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| J. Peacock
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| Vol #:
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| 27
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|
|
| C 1361
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| S. Peacock
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| Vol #:
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| 27
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|
|
| C 1362
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| T. Berry
|
| Vol #:
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| 27
|
|
|
| C 1363
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| S. Urban
|
| Vol #:
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| 27
|
|
|
| C 1364
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| S. Pauly
|
| Vol #:
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| 27
|
|
|
| C 1365
|
| J. Franklin
|
| Vol #:
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| 27
|
|
|
| C 1366
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| R. Aerni
|
| Vol #:
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| 27
|
|
| | | | | | | |
|
|
| C 1367
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| S. Budlong
|
| Vol #:
|
| 27
|
|
|
| C 1368
|
| S. Pressher
|
| Vol #:
|
| 27
|
|
|
| C 1369
|
| H. Braafen
|
| Vol #:
|
| 27
|
|
|
| C 1370
|
| N. Peesler
|
| Vol #:
|
| 27
|
|
|
| C 1371
|
| D. Davi
|
| Vol #:
|
| 27
|
|
|
| C 1372
|
| L. Stenburg
|
| Vol #:
|
| 27
|
|
|
| C 1373
|
| M. Redmond
|
| Vol #:
|
| 27
|
|
|
| C 1374
|
| C. Schultz
|
| Vol #:
|
| 27
|
|
|
| C 1375
|
| J. Gerson
|
| Vol #:
|
| 27
|
|
|
| C 1376
|
| B. Wickstrom
|
| Vol #:
|
| 27
|
|
|
| C 1377
|
| R. Gooding
|
| Vol #:
|
| 27
|
|
|
| C 1378
|
| M. Gooding
|
| Vol #:
|
| 27
|
|
|
| C 1379
|
| C. Figlioli
|
| Vol #:
|
| 27
|
|
|
| C 1380
|
| P. Jackson
|
| Vol #:
|
| 27
|
|
|
| C 1381
|
| E. Smith
|
| Vol #:
|
| 27
|
|
|
| C 1382
|
| D. Luchies
|
| Vol #:
|
| 27
|
|
|
| C 1383
|
| T. Williams
|
| Vol #:
|
| 27
|
|
|
| C 1384
|
| S. Portnoy
|
| Vol #:
|
| 27
|
|
|
| C 1385
|
| C. Bruggen
|
| Vol #:
|
| 27
|
|
|
| C 1386
|
| L. Deniger
|
| Vol #:
|
| 27
|
|
|
| C 1387
|
| R. Gooding
|
| Vol #:
|
| 27
|
|
|
| C 1388
|
| M. Gooding
|
| Vol #:
|
| 27
|
|
|
| C 1389
|
| B. Peckinpaugh
|
| Vol #:
|
| 27
|
|
|
| C 1390
|
| D. Davis
|
| Vol #:
|
| 27
|
|
|
| C 1391
|
| B. McCabe, CNP
|
| Vol #:
|
| 27
|
|
|
| C 1392
|
| B. Pierson
|
| Vol #:
|
| 27
|
|
|
| C 1393
|
| L. Roth
|
| Vol #:
|
| 27
|
|
|
| C 1394
|
| E. Stambaugh
|
| Vol #:
|
| 27
|
|
|
| C 1395
|
| S. Day
|
| Vol #:
|
| 27
|
|
|
| C 1396
|
| M. Hoag
|
| Vol #:
|
| 27
|
|
|
| C 1397
|
| S. Possman
|
| Vol #:
|
| 27
|
|
|
| C 1398
|
| S. Johnston
|
| Vol #:
|
| 27
|
|
|
| C 1399
|
| J. Boche
|
| Vol #:
|
| 27
|
|
|
| C 1400
|
| K. Owen
|
| Vol #:
|
| 27
|
|
|
| C 1401
|
| S. Martineau
|
| Vol #:
|
| 27
|
|
|
| C 1402
|
| M. Craven
|
| Vol #:
|
| 27
|
|
|
| C 1403
|
| B. Rosen
|
| Vol #:
|
| 27
|
|
| | | | | | | |
|
|
| C 1404
|
| B. Sproviero
|
| Vol #:
|
| 27
|
|
|
| C 1405
|
| J. Coffey
|
| Vol #:
|
| 27
|
|
|
| C 1406
|
| E. Bosco
|
| Vol #:
|
| 27
|
|
|
| C 1407
|
| S. Sprague
|
| Vol #:
|
| 27
|
|
|
| C 1408
|
| K. Wagner
|
| Vol #:
|
| 27
|
|
|
| C 1409
|
| J. Cheney
|
| Vol #:
|
| 27
|
|
|
| C 1410
|
| T. Albright
|
| Vol #:
|
| 27
|
|
|
| C 1411
|
| E. Bosco
|
| Vol #:
|
| 27
|
|
|
| C 1412
|
| S. Sprague
|
| Vol #:
|
| 27
|
|
|
| C 1413
|
| K. Wagner
|
| Vol #:
|
| 27
|
|
|
| C 1414
|
| J. Cheney
|
| Vol #:
|
| 27
|
|
|
| C 1415
|
| A. Greenberg
|
| Vol #:
|
| 27
|
|
|
| C 1416
|
| A. Clyde
|
| Vol #:
|
| 27
|
|
|
| C 1417
|
| E. Kazaniff
|
| Vol #:
|
| 27
|
|
|
| C 1418
|
| B. Schrogar
|
| Vol #:
|
| 27
|
|
|
| C 1419
|
| K. Fitch
|
| Vol #:
|
| 27
|
|
|
| C 1420
|
| D. Anderson
|
| Vol #:
|
| 27
|
|
|
| C 1421
|
| S. Obasa
|
| Vol #:
|
| 27
|
|
|
| C 1422
|
| C. Stout
|
| Vol #:
|
| 27
|
|
|
| C 1423
|
| M. McLean
|
| Vol #:
|
| 27
|
|
|
| C 1424
|
| C. Doumeng
|
| Vol #:
|
| 27
|
|
|
| C 1425
|
| E. Heywood
|
| Vol #:
|
| 27
|
|
|
| C 1426
|
| E. Heywood
|
| Vol #:
|
| 27
|
|
|
| C 1427
|
| G. Quast
|
| Vol #:
|
| 27
|
|
|
| C 1428
|
| D. Burnick
|
| Vol #:
|
| 27
|
|
|
| C 1429
|
| D. Jones
|
| Vol #:
|
| 27
|
|
|
| C 1430
|
| L. Hirst
|
| Vol #:
|
| 27
|
|
|
| C 1431
|
| R. Romero
|
| Vol #:
|
| 27
|
|
|
| C 1432
|
| M. McMahill
|
| Vol #:
|
| 27
|
|
|
| C 1433
|
| M. Kahn
|
| Vol #:
|
| 27
|
|
|
| C 1434
|
| C. Schrager
|
| Vol #:
|
| 27
|
|
|
| C 1435
|
| M. Boel
|
| Vol #:
|
| 27
|
|
|
| C 1436
|
| N. Stodder
|
| Vol #:
|
| 27
|
|
|
| C 1437
|
| K. Caldwell
|
| Vol #:
|
| 27
|
|
|
| C 1438
|
| C. Euse
|
| Vol #:
|
| 27
|
|
|
| C 1439
|
| V. Weigand
|
| Vol #:
|
| 27
|
|
|
| C 1440
|
| L. Lucas
|
| Vol #:
|
| 27
|
|
| | | | | | | |
|
|
| C 1441
|
| T. Pritikin
|
| Vol #:
|
| 27
|
|
|
| C 1442
|
| L. Bunker
|
| Vol #:
|
| 27
|
|
|
| C 1443
|
| L. Busch
|
| Vol #:
|
| 27
|
|
|
| C 1444
|
| M. Lawrence
|
| Vol #:
|
| 27
|
|
|
| C 1445
|
| L. Haenisch
|
| Vol #:
|
| 27
|
|
|
| C 1446
|
| S. Moses
|
| Vol #:
|
| 27
|
|
|
| C 1447
|
| T. Morgan
|
| Vol #:
|
| 27
|
|
|
| C 1448
|
| B. Arvanitis
|
| Vol #:
|
| 27
|
|
|
| C 1449
|
| G. Niksich
|
| Vol #:
|
| 27
|
|
|
| C 1450
|
| E. Niksich
|
| Vol #:
|
| 27
|
|
|
| C 1451
|
| C. Faller
|
| Vol #:
|
| 27
|
|
|
| C 1452
|
| T. Knetter
|
| Vol #:
|
| 27
|
|
|
| C 1453
|
| S. Bohne
|
| Vol #:
|
| 27
|
|
|
| C 1454
|
| Dr. Ostrowski
|
| Vol #:
|
| 27
|
|
|
| C 1455
|
| H. Wagner
|
| Vol #:
|
| 27
|
|
|
| C 1456
|
| G. Currie
|
| Vol #:
|
| 27
|
|
|
| C 1457
|
| J. Tucker
|
| Vol #:
|
| 27
|
|
|
| C 1458
|
| P. Marx
|
| Vol #:
|
| 27
|
|
|
| C 1459
|
| D. Porter
|
| Vol #:
|
| 27
|
|
|
| C 1460
|
| D. Porter
|
| Vol #:
|
| 27
|
|
|
| C 1461
|
| C. Stokes
|
| Vol #:
|
| 27
|
|
|
| C 1462
|
| K. Hurst
|
| Vol #:
|
| 27
|
|
|
| C 1463
|
| R. Michaels
|
| Vol #:
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| 27
|
|
|
| C 1464
|
| B. Kroeneake
|
| Vol #:
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| 27
|
|
|
| C 1465
|
| K. Johnson
|
| Vol #:
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| 27
|
|
|
| C 1466
|
| K. Racer
|
| Vol #:
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| 27
|
|
|
| C 1467
|
| F. Zylberblum
|
| Vol #:
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| 27
|
|
|
| C 1468
|
| G. Mutchnik
|
| Vol #:
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| 27
|
|
|
| C 1469
|
| K. Erickson
|
| Vol #:
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| 27
|
|
|
| C 1470
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| B. Janay
|
| Vol #:
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| 27
|
|
|
| C 1471
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| A. Stewart
|
| Vol #:
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| 27
|
|
|
| C 1472
|
| M. Reyes
|
| Vol #:
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| 27
|
|
|
| C 1473
|
| L. Womack
|
| Vol #:
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| 27
|
|
|
| C 1474
|
| A. Valenzuela
|
| Vol #:
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| 27
|
|
|
| C 1475
|
| T. Burns
|
| Vol #:
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| 27
|
|
|
| C 1476
|
| C. Belcher
|
| Vol #:
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| 27
|
|
|
| C 1477
|
| E. Voeltner
|
| Vol #:
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| 27
|
|
| | | | | | | |
|
|
| C 1478
|
| C. Sumpter
|
| Vol #:
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| 27
|
|
|
| C 1479
|
| P. Gilman
|
| Vol #:
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| 27
|
|
|
| C 1480
|
| E. Klaiber, MD
|
| Vol #:
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| 27
|
|
|
| C 1481
|
| M. Blanter
|
| Vol #:
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| 27
|
|
|
| C 1482
|
| P. Nordquist
|
| Vol #:
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| 27
|
|
|
| C 1483
|
| G. Boss
|
| Vol #:
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| 27
|
|
|
| C 1484
|
| G. Boss
|
| Vol #:
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| 27
|
|
|
| C 1485
|
| S. Hitchcock
|
| Vol #:
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| 27
|
|
|
| C 1486
|
| T. Walker
|
| Vol #:
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| 27
|
|
|
| C 1487
|
| T. Schmidt
|
| Vol #:
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| 27
|
|
|
| C 1488
|
| C. Simon
|
| Vol #:
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| 27
|
|
|
| C 1489
|
| S. Smith
|
| Vol #:
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| 27
|
|
|
| C 1490
|
| V. Groeller
|
| Vol #:
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| 27
|
|
|
| C 1491
|
| C. Terrell
|
| Vol #:
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| 27
|
|
|
| C 1492
|
| V. Gilbert
|
| Vol #:
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| 27
|
|
|
| C 1493
|
| M. Hayes
|
| Vol #:
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| 27
|
|
|
| C 1494
|
| W. Bike
|
| Vol #:
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| 27
|
|
|
| C 1495
|
| D. Kendall
|
| Vol #:
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| 27
|
|
|
| C 1496
|
| S. Paglialonga
|
| Vol #:
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| 27
|
|
|
| C 1497
|
| B. Hardick
|
| Vol #:
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| 27
|
|
|
| C 1498
|
| J. Giordamo
|
| Vol #:
|
| 27
|
|
|
| C 1499
|
| S. Hornidge
|
| Vol #:
|
| 27
|
|
|
| C 1500
|
| T. Preleoda
|
| Vol #:
|
| 27
|
|
|
| C 1501
|
| T. Gramlich
|
| Vol #:
|
| 27
|
|
|
| C 1502
|
| S. Hanna
|
| Vol #:
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| 27
|
|
|
| C 1503
|
| C. Tully
|
| Vol #:
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| 27
|
|
|
| C 1504
|
| C. Dine
|
| Vol #:
|
| 27
|
|
|
| C 1505
|
| P. Whiting
|
| Vol #:
|
| 27
|
|
|
| C 1506
|
| J. Gillet
|
| Vol #:
|
| 27
|
|
|
| C 1507
|
| J. Gillet
|
| Vol #:
|
| 27
|
|
|
| C 1508
|
| J. Gillet
|
| Vol #:
|
| 27
|
|
|
| C 1509
|
| No signature
|
| Vol #:
|
| 27
|
|
|
| C 1510
|
| K. Rands
|
| Vol #:
|
| 27
|
|
|
| C 1511
|
| M. Hofmann
|
| Vol #:
|
| 27
|
|
|
| C 1512
|
| M. Hofmann
|
| Vol #:
|
| 27
|
|
|
| C 1513
|
| M. Hofmann
|
| Vol #:
|
| 27
|
|
|
| C 1514
|
| T. Laehn
|
| Vol #:
|
| 27
|
|
| | | | | | | |
|
|
| C 1515
|
| C. Warfield
|
| Vol #:
|
| 27
|
|
|
| C 1516
|
| D. Terry
|
| Vol #:
|
| 27
|
|
|
| C 1517
|
| D. Bradley
|
| Vol #:
|
| 27
|
|
|
| C 1518
|
| R. Sheridan
|
| Vol #:
|
| 27
|
|
|
| C 1519
|
| K. Beach
|
| Vol #:
|
| 27
|
|
|
| C 1520
|
| L. Rutkai
|
| Vol #:
|
| 27
|
|
|
| C 1521
|
| D. Barnes
|
| Vol #:
|
| 27
|
|
|
| C 1522
|
| S. Terry
|
| Vol #:
|
| 27
|
|
|
| C 1523
|
| S. Courech
|
| Vol #:
|
| 27
|
|
|
| C 1524
|
| K. Waitzman
|
| Vol #:
|
| 27
|
|
|
| C 1525
|
| S. Zeien
|
| Vol #:
|
| 25
|
|
|
| C 1526
|
| R. Mitchell
|
| Vol #:
|
| 27
|
|
|
| C 1527
|
| M. Mobert
|
| Vol #:
|
| 27
|
|
|
| C 1528
|
| G. Hoffman
|
| Vol #:
|
| 27
|
|
|
| C 1529
|
| D. Entrekin
|
| Vol #:
|
| 27
|
|
|
| C 1530
|
| B. Bell
|
| Vol #:
|
| 27
|
|
|
| C 1531
|
| K. Bell
|
| Vol #:
|
| 27
|
|
|
| C 1532
|
| L. Courtney
|
| Vol #:
|
| 27
|
|
|
| C 1533
|
| P. Gilman
|
| Vol #:
|
| 27
|
|
|
| C 1534
|
| T. Gilman
|
| Vol #:
|
| 27
|
|
|
| C 1535
|
| M. Gonzalez
|
| Vol #:
|
| 27
|
|
|
| C 1536
|
| A. Curry
|
| Vol #:
|
| 27
|
|
|
| C 1537
|
| A. Pirtle
|
| Vol #:
|
| 27
|
|
|
| C 1538
|
| T. Shough
|
| Vol #:
|
| 27
|
|
|
| C 1539
|
| M. Mancuso
|
| Vol #:
|
| 27
|
|
|
| C 1540
|
| P. Biery
|
| Vol #:
|
| 27
|
|
|
| C 1541
|
| S. Stein
|
| Vol #:
|
| 27
|
|
|
| C 1542
|
| B. Huweiler
|
| Vol #:
|
| 27
|
|
|
| C 1543
|
| D. Korkmas
|
| Vol #:
|
| 27
|
|
|
| C 1544
|
| C. Jung
|
| Vol #:
|
| 27
|
|
|
| C 1545
|
| P. Gilmartin
|
| Vol #:
|
| 27
|
|
|
| C 1546
|
| S. Barca
|
| Vol #:
|
| 27
|
|
|
| C 1547
|
| S. Hacker
|
| Vol #:
|
| 27
|
|
|
| C 1548
|
| M. Zabal
|
| Vol #:
|
| 27
|
|
|
| C 1549
|
| E. Stansbury
|
| Vol #:
|
| 27
|
|
|
| C 1550
|
| K. Chamberlin
|
| Vol #:
|
| 27
|
|
|
| C 1551
|
| L. Ferguson
|
| Vol #:
|
| 28
|
|
| | | | | | | |
|
|
| C 1552
|
| M. Jalian
|
| Vol #:
|
| 28
|
|
|
| C 1553
|
| S. Meierfeld
|
| Vol #:
|
| 28
|
|
|
| C 1554
|
| Dr. C. Hernandez
|
| Vol #:
|
| 28
|
|
|
| C 1555
|
| A. Mausling
|
| Vol #:
|
| 28
|
|
|
| C 1556
|
| J. Kosta
|
| Vol #:
|
| 28
|
|
|
| C 1557
|
| D. Sims
|
| Vol #:
|
| 28
|
|
|
| C 1558
|
| J. Ramsey
|
| Vol #:
|
| 28
|
|
|
| C 1559
|
| D. Sims
|
| Vol #:
|
| 28
|
|
|
| C 1560
|
| J. Ramsey
|
| Vol #:
|
| 28
|
|
|
| C 1561
|
| V. Blokland
|
| Vol #:
|
| 28
|
|
|
| C 1562
|
| D. Pettit
|
| Vol #:
|
| 28
|
|
|
| C 1563
|
| V. Rittenbach
|
| Vol #:
|
| 28
|
|
|
| C 1564
|
| S. Caffarel
|
| Vol #:
|
| 28
|
|
|
| C 1565
|
| L. Boldin
|
| Vol #:
|
| 28
|
|
|
| C 1566
|
| G. Stratton
|
| Vol #:
|
| 28
|
|
|
| C 1567
|
| L. Peterson
|
| Vol #:
|
| 28
|
|
|
| C 1568
|
| P. Hanson
|
| Vol #:
|
| 28
|
|
|
| C 1569
|
| L. Duba
|
| Vol #:
|
| 28
|
|
|
| C 1570
|
| K. Schroeder
|
| Vol #:
|
| 28
|
|
|
| C 1571
|
| E. Mani
|
| Vol #:
|
| 28
|
|
|
| C 1572
|
| P. Mani
|
| Vol #:
|
| 28
|
|
|
| C 1573
|
| V. Vena
|
| Vol #:
|
| 28
|
|
|
| C 1574
|
| L. Wild
|
| Vol #:
|
| 28
|
|
|
| C 1575
|
| D. Johnson
|
| Vol #:
|
| 28
|
|
|
| C 1576
|
| M. Cornblum
|
| Vol #:
|
| 28
|
|
|
| C 1577
|
| V. Vena
|
| Vol #:
|
| 28
|
|
|
| C 1578
|
| B. Roberts
|
| Vol #:
|
| 28
|
|
|
| C 1579
|
| M. Arsenault
|
| Vol #:
|
| 28
|
|
|
| C 1580
|
| R. Arsenault
|
| Vol #:
|
| 28
|
|
|
| C 1581
|
| D. Turiano
|
| Vol #:
|
| 28
|
|
|
| C 1582
|
| M. Hoover
|
| Vol #:
|
| 28
|
|
|
| C 1583
|
| E. Murley
|
| Vol #:
|
| 28
|
|
|
| C 1584
|
| V. Peace
|
| Vol #:
|
| 28
|
|
|
| C 1585
|
| M. Hempton
|
| Vol #:
|
| 28
|
|
|
| C 1586
|
| S. Riley
|
| Vol #:
|
| 28
|
|
|
| C 1587
|
| A. Roberts
|
| Vol #:
|
| 28
|
|
|
| C 1588
|
| A. Smith
|
| Vol #:
|
| 28
|
|
| | | | | | | |
|
|
| C 1589
|
| J. Thomas
|
| Vol #:
|
| 28
|
|
|
| C 1590
|
| D. Murphy
|
| Vol #:
|
| 28
|
|
|
| C 1591
|
| S. Murphy
|
| Vol #:
|
| 28
|
|
|
| C 1592
|
| V. Lotz
|
| Vol #:
|
| 28
|
|
|
| C 1593
|
| E. Houston
|
| Vol #:
|
| 28
|
|
|
| C 1594
|
| C. Sutherland
|
| Vol #:
|
| 28
|
|
|
| C 1595
|
| H. Woodhall
|
| Vol #:
|
| 28
|
|
|
| C 1596
|
| L. Gange
|
| Vol #:
|
| 28
|
|
|
| C 1597
|
| P. Kasi
|
| Vol #:
|
| 28
|
|
|
| C 1598
|
| J. Gange
|
| Vol #:
|
| 28
|
|
|
| EC
6115
|
| Ms. Barbara Zinn
|
| Vol #:
|
| 24
|
|
|
| EC
6116
|
| Mrs. Linda Knott
|
| Vol #:
|
| 24
|
|
|
| EC
6117
|
| Mrs. jO mARY THOMPSON
|
| Vol #:
|
| 24
|
|
|
| EC
6118
|
| Ms. Elaine Weston
|
| Vol #:
|
| 24
|
|
|
| EC
6119
|
| Mrs. dixie murphy
|
| Vol #:
|
| 24
|
|
|
| EC
6120
|
| Ms. Emily Thompson
|
| Vol #:
|
| 24
|
|
|
| EC
6121
|
| Mrs. Toni Whelton
|
| Vol #:
|
| 24
|
|
|
| EC
6122
|
| Mrs. Angie Roper
|
| Vol #:
|
| 24
|
|
|
| EC
6123
|
| Ms. Marsha Vargas
|
| Vol #:
|
| 24
|
|
|
| EC
6124
|
| Mrs. Kathleen Hefner
|
| Vol #:
|
| 24
|
|
|
| EC
6125
|
| Ms. Dwainna Wulfjen
|
| Vol #:
|
| 24
|
|
|
| EC
6126
|
| Mrs. Janelle D. Meyer
|
| Vol #:
|
| 24
|
|
|
| EC
6127
|
| Mrs. Marilou Dotson
|
| Vol #:
|
| 24
|
|
|
| EC
6128
|
| Mrs. Anne Zawada
|
| Vol #:
|
| 24
|
|
|
| EC
6129
|
| Mr. Octavio de Leon
|
| Vol #:
|
| 24
|
|
|
| EC
6130
|
| Ms. Theresa Woodsong
|
| Vol #:
|
| 24
|
|
|
| EC
6131
|
| Ms. Robin Hart
|
| Vol #:
|
| 24
|
|
|
| EC
6132
|
| Mr. Justin Brock
|
| Vol #:
|
| 24
|
|
|
| EC
6133
|
| Mrs. Suzette Brown
|
| Vol #:
|
| 24
|
|
|
| EC
6134
|
| Ms. Barbara Farran
|
| Vol #:
|
| 24
|
|
|
| EC
6135
|
| Ms. Tanya Martin
|
| Vol #:
|
| 24
|
|
|
| EC
6136
|
| Mrs. Heidi Hatten
|
| Vol #:
|
| 24
|
|
|
| EC
6137
|
| Mrs. Anna Gerus
|
| Vol #:
|
| 24
|
|
|
| EC
6138
|
| Ms. Patricia Meyer
|
| Vol #:
|
| 24
|
|
|
| EC
6139
|
| Ms. Lynda White
|
| Vol #:
|
| 24
|
|
|
| EC
6140
|
| New Choices Counseling
|
| Vol #:
|
| 24
|
|
|
| EC
6141
|
| Mrs. MARSHA HACKER
|
| Vol #:
|
| 24
|
|
| | | | | | | |
|
|
| EC
6142
|
| Mrs. Betty Feusner
|
| Vol #:
|
| 24
|
|
|
| EC
6143
|
| Mrs. Mary M. Bergey
|
| Vol #:
|
| 24
|
|
|
| EC
6144
|
| Mrs. Diane Lord
|
| Vol #:
|
| 24
|
|
|
| EC
6145
|
| Mrs. Linda LeBold
|
| Vol #:
|
| 24
|
|
|
| EC
6146
|
| Mrs. elizabeth kramer
|
| Vol #:
|
| 24
|
|
|
| EC
6147
|
| Mrs. Sherry Kay
|
| Vol #:
|
| 24
|
|
|
| EC
6148
|
| Mrs. Roxanne Cieszynski
|
| Vol #:
|
| 24
|
|
|
| EC
6149
|
| Dr. Carol F. Hershey
|
| Vol #:
|
| 24
|
|
|
| EC
6150
|
| Mrs. Debora Fisher
|
| Vol #:
|
| 24
|
|
|
| EC
6151
|
| Mrs. Deborah Dunlap
|
| Vol #:
|
| 24
|
|
|
| EC
6152
|
| Ms. Carol Ambuhl
|
| Vol #:
|
| 24
|
|
|
| EC
6153
|
| Mrs. Kay Dunn
|
| Vol #:
|
| 24
|
|
|
| EC
6154
|
| Ms. Stephanie Pumphrey
|
| Vol #:
|
| 24
|
|
|
| EC
6155
|
| Mr. Justin Dew
|
| Vol #:
|
| 24
|
|
|
| EC
6156
|
| Ms. Barbara Peckham
|
| Vol #:
|
| 24
|
|
|
| EC
6157
|
| Ms. Mae Dozier
|
| Vol #:
|
| 24
|
|
|
| EC
6158
|
| Mrs. Christine Jacobs
|
| Vol #:
|
| 24
|
|
|
| EC
6159
|
| Mrs. Johnie Murphy
|
| Vol #:
|
| 24
|
|
|
| EC
6160
|
| Ms. Barbara Stanton
|
| Vol #:
|
| 24
|
|
|
| EC
6161
|
| Dr. Caroline Zsambok
|
| Vol #:
|
| 24
|
|
|
| EC
6162
|
| Mrs. JALENE HOWSE
|
| Vol #:
|
| 24
|
|
|
| EC
6163
|
| Mrs. REBECCA H O'REAR
|
| Vol #:
|
| 24
|
|
|
| EC
6164
|
| Ms. Raven Cox
|
| Vol #:
|
| 24
|
|
|
| EC
6165
|
| Miss. Gina Eide
|
| Vol #:
|
| 24
|
|
|
| EC
6166
|
| Ms. Sandy Dinzeo
|
| Vol #:
|
| 24
|
|
|
| EC
6167
|
| Ms. Catherine Hupp
|
| Vol #:
|
| 24
|
|
|
| EC
6168
|
| Mrs. Terry Wojciehowski
|
| Vol #:
|
| 24
|
|
|
| EC
6169
|
| Miss. lana lien
|
| Vol #:
|
| 24
|
|
|
| EC
6170
|
| Ms. michelle regulus
|
| Vol #:
|
| 24
|
|
|
| EC
6171
|
| Mrs. Dorothy Pascale
|
| Vol #:
|
| 24
|
|
|
| EC
6172
|
| Mrs. sharon sponseller
|
| Vol #:
|
| 24
|
|
|
| EC
6173
|
| Ms. Mary Garcia
|
| Vol #:
|
| 24
|
|
|
| EC
6174
|
| Mrs. Suzanne Martinez
|
| Vol #:
|
| 24
|
|
|
| EC
6175
|
| Ms. Jane Croft
|
| Vol #:
|
| 24
|
|
|
| EC
6176
|
| Mrs. Alice Mertz
|
| Vol #:
|
| 24
|
|
|
| EC
6177
|
| Ms. Nancy Moravecek
|
| Vol #:
|
| 24
|
|
|
| EC
6178
|
| Mrs. Rebecca Burgener
|
| Vol #:
|
| 24
|
|
| | | | | | | |
|
|
| EC
6179
|
| Overall Music
|
| Vol #:
|
| 24
|
|
|
| EC
6180
|
| Ms. Tammy Keller
|
| Vol #:
|
| 24
|
|
|
| EC
6181
|
| Mrs. Freda Rennick
|
| Vol #:
|
| 24
|
|
|
| EC
6182
|
| Ms. Kris Nowka
|
| Vol #:
|
| 24
|
|
|
| EC
6183
|
| Ms. Kathleen ORourke
|
| Vol #:
|
| 24
|
|
|
| EC
6184
|
| Dr. Allison Paxton
|
| Vol #:
|
| 24
|
|
|
| EC
6185
|
| Ms. Lisa Foley-Pellicani
|
| Vol #:
|
| 24
|
|
|
| EC
6186
|
| Ms. Donna Murphy
|
| Vol #:
|
| 24
|
|
|
| EC
6187
|
| Mrs. Samantha Caudle
|
| Vol #:
|
| 24
|
|
|
| EC
6188
|
| Ms. Melissa Prewitt
|
| Vol #:
|
| 24
|
|
|
| EC
6189
|
| Mrs. Bonnie Berry
|
| Vol #:
|
| 24
|
|
|
| EC
6190
|
| Ms. Rica Polansky
|
| Vol #:
|
| 24
|
|
|
| EC
6191
|
| Mrs. Dawn Coe
|
| Vol #:
|
| 24
|
|
|
| EC
6192
|
| Ms. trish thomson
|
| Vol #:
|
| 24
|
|
|
| EC
6193
|
| Mrs. Shirley Cohn
|
| Vol #:
|
| 24
|
|
|
| EC
6194
|
| Mrs. Cheryl Nelson
|
| Vol #:
|
| 24
|
|
|
| EC 6195
|
| Mrs. Katherine Davis
|
| Vol #:
|
| 24
|
|
|
| EC 6196
|
| Ms. Kelly Vallanidngham
|
| Vol #:
|
| 24
|
|
|
| EC
6197
|
| Ms. Annette Cossentine
|
| Vol #:
|
| 24
|
|
|
| EC
6198
|
| Mrs. Jimmie Gail Rietcheck
|
| Vol #:
|
| 24
|
|
|
| EC 6199
|
| Mrs. Kaye Mencias
|
| Vol #:
|
| 24
|
|
|
| EC
6200
|
| Ms. Ellen Carnahan
|
| Vol #:
|
| 24
|
|
|
| EC
6201
|
| Mrs. Sherry Higgins
|
| Vol #:
|
| 24
|
|
|
| EC
6202
|
| Mrs. Holly Falls
|
| Vol #:
|
| 24
|
|
|
| EC
6203
|
| Ms. Linda Huntting Congdon
|
| Vol #:
|
| 24
|
|
|
| EC
6204
|
| Mrs. Peggy Ragsdale
|
| Vol #:
|
| 24
|
|
|
| EC
6205
|
| Mrs. jacquie blomberg
|
| Vol #:
|
| 24
|
|
|
| EC
6206
|
| Mrs. Judith Robertson
|
| Vol #:
|
| 24
|
|
|
| EC
6207
|
| Mrs. Donna Woitha
|
| Vol #:
|
| 24
|
|
|
| EC
6208
|
| Dr. Richard Stancliff
|
| Vol #:
|
| 24
|
|
|
| EC
6209
|
| Ms. Pam Wiley
|
| Vol #:
|
| 24
|
|
|
| EC
6210
|
| Mrs. Jennifer Haney
|
| Vol #:
|
| 24
|
|
|
| EC
6211
|
| Mr. Lawrence Rietcheck
|
| Vol #:
|
| 24
|
|
|
| EC
6212
|
| Ms. Maria Rose
|
| Vol #:
|
| 24
|
|
|
| EC
6213
|
| Ms. Louise Koshollek
|
| Vol #:
|
| 24
|
|
|
| EC
6214
|
| Mrs. Ekaterina Shavlovsky
|
| Vol #:
|
| 24
|
|
|
| EC
6215
|
| Mrs. Kelly Maren
|
| Vol #:
|
| 24
|
|
| | | | | | | |
|
|
| EC
6216
|
| Mrs. Barbara Enyart
|
| Vol #:
|
| 24
|
|
|
| EC
6217
|
| Ms. Rebekah Cleckler
|
| Vol #:
|
| 24
|
|
|
| EC
6218
|
| Mrs. linda foster
|
| Vol #:
|
| 24
|
|
|
| EC 6219
|
| Mrs. Jean Piwonka
|
| Vol #:
|
| 24
|
|
|
| EC
6220
|
| own
|
| Vol #:
|
| 24
|
|
|
| EC
6221
|
| Mrs. Cheryl Casini
|
| Vol #:
|
| 24
|
|
|
| EC
6222
|
| almira
|
| Vol #:
|
| 24
|
|
|
| EC
6223
|
| Mrs. Jean Gerbracht
|
| Vol #:
|
| 24
|
|
|
| EC
6224
|
| Mr. Tom Abraham
|
| Vol #:
|
| 24
|
|
|
| EC
6225
|
| Ms. Margaret Dart
|
| Vol #:
|
| 24
|
|
|
| EC
6226
|
| Ms. Patti Goldfarb
|
| Vol #:
|
| 24
|
|
|
| EC
6227
|
| 20/20 opticians
|
| Vol #:
|
| 25
|
|
|
| EC
6228
|
| Mrs. Diane Aarnaes
|
| Vol #:
|
| 25
|
|
|
| EC
6229
|
| Mrs. Margaret Marquoit
|
| Vol #:
|
| 25
|
|
|
| EC
6230
|
| Mrs. Susan Neff
|
| Vol #:
|
| 25
|
|
|
| EC
6231
|
| Ms. Emmie Gardea
|
| Vol #:
|
| 25
|
|
|
| EC
6232
|
| Mr. Alan Hamel
|
| Vol #:
|
| 25
|
|
|
| EC
6233
|
| Mr. William Wiser
|
| Vol #:
|
| 25
|
|
|
| EC
6234
|
| Mrs. lyn yerman
|
| Vol #:
|
| 25
|
|
|
| EC
6235
|
| Mrs. L. Kay Hernandez
|
| Vol #:
|
| 25
|
|
|
| EC
6236
|
| Mrs. Stephanie Logan
|
| Vol #:
|
| 25
|
|
|
| EC
6237
|
| Ms. Susan Isaacson
|
| Vol #:
|
| 25
|
|
|
| EC
6238
|
| Ms. LaVonne COLLETTE
|
| Vol #:
|
| 25
|
|
|
| EC
6239
|
| SYTHC
|
| Vol #:
|
| 25
|
|
|
| EC
6240
|
| Ms. terrea hannah
|
| Vol #:
|
| 25
|
|
|
| EC
6241
|
| Mrs. Sheryl Rose
|
| Vol #:
|
| 25
|
|
|
| EC
6242
|
| Miss. Tamra Hernandez
|
| Vol #:
|
| 25
|
|
|
| EC
6243
|
| Ms. Elizabeth Hamel
|
| Vol #:
|
| 25
|
|
|
| EC
6244
|
| Mrs. Terryn Dwyer
|
| Vol #:
|
| 25
|
|
|
| EC
6245
|
| Mrs. Glenna Citron
|
| Vol #:
|
| 25
|
|
|
| EC
6246
|
| Ms. C Coogan
|
| Vol #:
|
| 25
|
|
|
| EC
6247
|
| Mrs. mary hudspeth
|
| Vol #:
|
| 25
|
|
|
| EC
6248
|
| Ms. Susan Moates
|
| Vol #:
|
| 25
|
|
|
| EC
6249
|
| Mrs. Merilyn Taylor
|
| Vol #:
|
| 25
|
|
|
| EC
6250
|
| Dr. Angelo Chirban
|
| Vol #:
|
| 25
|
|
|
| EC
6251
|
| Ms. Jacquelyn Lynch
|
| Vol #:
|
| 25
|
|
|
| EC
6252
|
| ellen smith dolin, lcsw
|
| Vol #:
|
| 25
|
|
| | | | | | | | |
|
|
| EC
6253
|
| Mrs. KATHLEEN SMITH
|
| Vol #:
|
| 25
|
|
|
| EC
6254
|
| Ms. Nancy Pritchard
|
| Vol #:
|
| 25
|
|
|
| EC
6255
|
| Mrs. Kristi Hackman
|
| Vol #:
|
| 25
|
|
|
| EC
6256
|
| Mrs. Cathleen Grittner
|
| Vol #:
|
| 25
|
|
|
| EC
6257
|
| Ms. Lynell Hage
|
| Vol #:
|
| 25
|
|
|
| EC
6258
|
| Miss. Angela Florio
|
| Vol #:
|
| 25
|
|
|
| EC
6259
|
| Ms. Kayla Wetsel
|
| Vol #:
|
| 25
|
|
|
| 2005P-0432
|
| Ban all Non-medical Uses of the Antibacterial Agent Triclosan
|
|
|
| LET
1
|
| Ciba Specialty Chemicals Corporation USA, (Ciba)
|
| Vol #:
|
| 1
|
|
|
| 2005P-0460
|
| Determination of Ramipril Tablets, 1.25 mg, 2.5 mg, 5 mg and 10 mg
|
|
|
| C
1
|
| Hyman, Phelps & McNamara, P.C.
|
| Vol #:
|
| 1
|
|
|
| C 2
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
| 2005P-0464
|
| Remove metered-dose inhalers (MDI) containing the single active moieties beclomethasone, fluticasone, and salmeterol, respectively, from the essential-use list of ozone-depleting substance
|
|
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
| 2005P-0472
|
| ANDA for Ramipril Instant Release Oral Tablets
|
|
|
| C
1
|
| Hyman, Phelps & McNamara, P.C.
|
| Vol #:
|
| 1
|
|
|
| 2005V-0499
|
| Laser Pointer/Illuminator products GCP-1A. GCP-2
|
|
|
| VRA
1
|
| HFZ-200 to NVEC (Night Vision Equipment Company)
|
| Vol #:
|
| 1
|
|
|
| 2006D-0066
|
| Guidance for Industry and FDA Staff: Whole Grains Label Statements
|
|
|
| BKG
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2006P-0093
|
| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
|
|
|
|
|
|
| ACK
1
|
| HFA-305 to ECO Animal Health
|
| Vol #:
|
| 1
|
|
|
| ACK 2
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| ECO Animal Health
|
| Vol #:
|
| 1
|
|
|
| 2006P-0094
|
| To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
|
|
|
|
|
|
| ACK
1
|
| HFA-305 to The Sugar Association
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| The Sugar Association
|
| Vol #:
|
| 1
|
|
|
| 2006Q-0091
|
| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
|
|
| | | | | | | |
|
|
| ACK
1
|
| FDA/CFSAN to Johnson Nutriton Solutions LLC
|
| Vol #:
|
| 4
|
|
|
| QHC
1
|
| U S Canola Association
|
| Vol #:
|
| 1
|
|
|