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| Dockets Entered
On February 10, 2006
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| 2003P-0564
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| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
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| 2004D-0385
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| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
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| 2004E-0307
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| Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
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| 2004P-0183
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| Nutrient Content Claim: Expand Lean Definition
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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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-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005P-0166
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| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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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-0440
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| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
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| 2006D-0012
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| Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
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| 2006D-0020
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| 2006P-0071
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| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
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| 2006P-0072
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| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
305
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| Shannon Minerals Inc
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| Vol #:
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| 242
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| RPT
306
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| AIMBR Life Sciences Inc
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| Vol #:
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| 243
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| RPT
307
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| Efficas
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| Vol #:
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| 244
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| RPT
308
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| Geranti USA Inc
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| Vol #:
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| 245
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| RPT
309
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| Louis Montgomery Enterprises
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| Vol #:
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| 230
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 9
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| G. Chorney
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| Vol #:
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| 3
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| EMC 10
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| R. Vargas
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| Vol #:
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| 3
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| EMC 11
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| C. Zenteno
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| Vol #:
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| 3
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| EMC 12
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| S.V.
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| Vol #:
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| 3
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| EMC 13
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| S. B.
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| Vol #:
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| 3
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| EMC 14
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| M. Houseknecht
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| Vol #:
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| 3
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| EMC 15
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| C. Pollard
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| Vol #:
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| 3
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| EMC 16
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| T. Glancz
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| Vol #:
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| 3
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| EMC 17
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| J. Menashe
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| Vol #:
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| 3
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 627
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| B Wilkie
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| Vol #:
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| 24
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| EMC 628
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| TDSB Trustee for St Pauls
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| Vol #:
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| 24
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| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1306
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| J. Walinski
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| Vol #:
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| 6
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| EMC 1307
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| M and G Tongate
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| Vol #:
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| 6
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| EMC 1308
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| C. Wexler
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| Vol #:
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| 6
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| EMC 1309
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| S. Moroses
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| Vol #:
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| 6
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| EMC 1310
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| M. Marple
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 605
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| Mission Possible International
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| Vol #:
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| 9
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| EMC
606
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| Calorie Control Council
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| Vol #:
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| 9
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| EMC 607
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| Mission Possible International
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| Vol #:
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| 9
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1216
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| C. Hoffman
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| Vol #:
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| 12
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| EMC 1217
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| J. Sterling
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| Vol #:
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| 12
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| EMC 1218
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| no signature
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| Vol #:
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| 12
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| EMC 1219
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| D. Kipp
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| Vol #:
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| 12
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| EMC 1220
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| J. Voelker
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| Vol #:
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| 12
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| EMC 1221
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| S. Martinez
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| Vol #:
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| 12
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| EMC 1222
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| T. Snell
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| Vol #:
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| 12
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| EMC 1223
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| no signature
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| Vol #:
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| 12
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| EMC 1224
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| no signature
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| Vol #:
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| 12
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|
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| 2003N-0169
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| Dental Amalgam; Request for Information
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|
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|
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| EMC
295
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| Consumers for Dental Choice
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| Vol #:
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| 7
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|
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| EMC
296
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| Consumers for Dental Choice
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| Vol #:
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| 7
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| EMC
297
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| Consumers for Dental Choice
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| Vol #:
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| 7
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| EMC
298
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| Consumers for Dental Choice
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| Vol #:
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| 7
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| EMC
299
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| Consumers for Dental Choice
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| Vol #:
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| 7
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| | | | | | | | |
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| |
|
| 2003P-0564
|
| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0385
|
| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
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| 1
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|
|
|
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| NAD
2
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
|
| 2004E-0307
|
| Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2004P-0183
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| Nutrient Content Claim: Expand Lean Definition
|
|
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|
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| EMC
2
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| Washington Legal Foundation (WLF)
|
| Vol #:
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| 1
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|
|
|
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| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
|
|
|
|
| EMC 1
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| B. Sachau
|
| Vol #:
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| 1
|
|
|
|
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| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
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| EMC 95
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| D. Blanset
|
| Vol #:
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| 11
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| EMC 96
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| K. Kieft
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| Vol #:
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| 11
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| EMC 97
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| P. Hasleton
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| Vol #:
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| 11
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| EMC 98
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| M. Thorwaldson
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| Vol #:
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| 11
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| EMC 99
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| L. Woosley
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| Vol #:
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| 11
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| EMC 100
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| J. Ayo
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| Vol #:
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| 11
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| EMC 101
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| L. Mackenzie
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| Vol #:
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| 11
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| EMC 102
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| W. Butterfield
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| Vol #:
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| 11
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| EMC 103
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| M. Church
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| Vol #:
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| 11
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| EMC 104
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| B. Tulett
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| Vol #:
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| 11
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| EMC 105
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| S. Burns
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| Vol #:
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| 11
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| EMC 106
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| S. Parker
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| Vol #:
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| 11
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| EMC 107
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| R. Washick
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| Vol #:
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| 11
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| EMC 108
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| M. Cardillo
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| Vol #:
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| 11
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| EMC 109
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| A. Dungan
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| Vol #:
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| 11
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| EMC 110
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| D. Tuten
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| Vol #:
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| 11
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| EMC 111
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| B. King
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| Vol #:
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| 11
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| EMC 112
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| L. Leazenby
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| Vol #:
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| 11
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| EMC 113
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| J. Lane
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| Vol #:
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| 11
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| EMC 114
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| R. Freeman
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| Vol #:
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| 11
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| EMC 115
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| M. Daly
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| Vol #:
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| 11
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| EMC 116
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| H. Pierpont
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| Vol #:
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| 11
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| | | | | | | | |
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| EMC 265
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| C. Campbell, Esq
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| Vol #:
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| 1
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| EMC 266
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| K. McLean
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| Vol #:
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| 11
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| EMC 267
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| T. Turner
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| Vol #:
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| 11
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| EMC 268
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| J. Gordon
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| Vol #:
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| 11
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| EMC 269
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| L. Blythe
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| Vol #:
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| 11
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| EMC 270
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| A. Burger
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| Vol #:
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| 11
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| EMC 271
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| S. Sullivan
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| Vol #:
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| 11
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| EMC 272
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| S. Brisbine
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| Vol #:
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| 11
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| EMC 273
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| D. Stillings, RN
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| Vol #:
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| 11
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| EMC 274
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| C. Williams
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| Vol #:
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| 11
|
|
| |
|
| 2005N-0479
|
| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
|
|
|
|
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|
|
|
|
|
| SUP 1
|
| Hyman, Phelps & McNamara, P.C.
|
| Vol #:
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| 2
|
|
|
|
|
| 2005P-0166
|
| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
|
|
|
|
|
| HER
1
|
| National Myopia Prevention Association (IMPA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0377
|
| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
|
|
|
|
|
| SUP
5
Attachment
|
| Department of the Planet Earth
|
| Vol #:
|
| 3
|
|
|
|
|
| SUP
6
Attachment
|
| Department of the Planet Earth
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 641
|
| M Hawthorpe
|
| Vol #:
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| 12
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|
|
|
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| C 642
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| M. Nasatir
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| Vol #:
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| 12
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| C 643
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| G. Bennett
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| Vol #:
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| 12
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|
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|
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| C 644
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| J. Glinski, RN
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| Vol #:
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| 12
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|
|
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| C 645
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| M. Strefert
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| Vol #:
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| 12
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| C 646
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| M. Kuzila
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| Vol #:
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| 12
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|
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| C 647
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| S. Shelton
|
| Vol #:
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| 12
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|
|
|
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| C 648
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| M. Lerner
|
| Vol #:
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| 12
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|
|
|
|
| C 649
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| J. Scanlan
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| Vol #:
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| 12
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|
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|
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| C 650
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| U. Arini
|
| Vol #:
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| 12
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|
|
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| C 651
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| L. Womack
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| Vol #:
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| 12
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| C 652
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| N. Dixon
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| Vol #:
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| 12
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|
|
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| C 653
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| B. Rice
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| Vol #:
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| 12
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|
|
|
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| C 654
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| H. Keene
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| Vol #:
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| 12
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|
|
|
|
| C 655
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| B. Schwinn
|
| Vol #:
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| 12
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|
| | | | | | | | |
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0020
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
|
|
|
|
|
| BKG
1
|
| Orthopedic and Rehabilitation Devices Panel
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0019
|
| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
|
|
|
|
|
| BKG 1
|
| Orthopedic and Rehabilitation Devices Panel
|
| Vol #:
|
| 1
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0071
|
| 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
|
|
|
|
|
| ACK
1
|
| HFA- 305 to Regulatory & Clinical Research Institute, Inc ( RCRI )
|
| Vol #:
|
| 1
|
|
|
|
|
| CCP
1
|
| Regulatory & Clinical Research Institute, Inc ( RCRI )
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0072
|
| ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
|
|
|
|
|
| ACK
1
|
| HFA-305 to Olsson,Frank & Weeda P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Olsson,Frank and Weeda, P.C.
|
| Vol #:
|
| 1
|
|
