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| Dockets Entered
On September 7, 2006
Table of Contents
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| Docket #
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| Title
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| 1977N-0317
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| Tetracycline-Proposal to Revise Regulations
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| 1980F-0073
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| Safe use of Bix Benzene and Bis Cyclohexane in the Production of Polyurethane Resins
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| |
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| 1997D-0318
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| Revised Precautionary Measure to Reduce Transmission of CJD
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| |
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
|
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| 2003E-0407
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| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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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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| 2004E-0307
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| Patent Extension for ALIMTA (pemetrexed), U.S. Patent No. 5,344,932
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| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
|
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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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| |
|
|
| 2006E-0260
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| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
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| |
|
|
| 2006E-0282
|
| Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319
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| |
|
|
| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| |
|
|
| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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| |
|
|
| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| |
|
|
| 2006N-0292
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| Unique Device Identification
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| |
|
|
| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| |
|
|
| 2006P-0101
|
| Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
|
| |
|
|
| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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| |
|
|
| 2006P-0263
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| ANADA suitability for Neomycin
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| |
|
|
| 2006P-0265
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| to permit an ANDA Suitability for Cefdinir
|
| |
|
|
| 2006P-0267
|
| ANDA Suitability for Dextroamphetamine Sulfate Tablets
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| |
|
|
| 2006P-0281
|
| Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet
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| |
|
|
| 2006P-0285
|
| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
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| |
|
|
| 2006P-0311
|
| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
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| |
|
|
| 2006P-0313
|
| Removal of labeling for MediSense Precision Advanced Diabetes Management System
|
| |
|
|
| 2006P-0316
|
| Health Claim: Phyposterols and Reduced Risk of Coronary Heart Disease
|
| |
|
|
| 2006P-0369
|
| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
|
| |
|
|
| 2006P-0370
|
| Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)
|
| |
|
|
| 1977N-0317
|
| Tetracycline-Proposal to Revise Regulations
|
| |
|
|
| LET 24
|
| Number Not Used
|
| Vol #:
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| 22
|
|
| | | | | | | | |
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|
|
| 1980F-0073
|
| Safe use of Bix Benzene and Bis Cyclohexane in the Production of Polyurethane Resins
|
| |
|
|
| FONS 1
|
| Finding of no Significant Impact
|
| Vol #:
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| 1
|
| |
|
|
| 1997D-0318
|
| Revised Precautionary Measure to Reduce Transmission of CJD
|
| |
|
|
| C 37
|
| Mayo Clinic
|
| Vol #:
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| 4
|
|
| |
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| EMC 4420
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| W. Lee
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| Vol #:
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| 320
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| EMC 4421
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| D. Clark
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| Vol #:
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| 320
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| EMC 4422
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| B. Robinson
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| Vol #:
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| 320
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| EMC 4423
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| D. Brook
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| Vol #:
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| 320
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| EMC 4424
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| V. Sawyer
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| Vol #:
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| 320
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| EMC 4425
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| R. Budin
|
| Vol #:
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| 320
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| EMC 4426
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| J. Harker
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| Vol #:
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| 320
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| EMC 4427
|
| S. Stark
|
| Vol #:
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| 320
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| |
|
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| EMC 4428
|
| J. Nelson
|
| Vol #:
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| 320
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 650
|
| M. Underwood
|
| Vol #:
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| 24
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 255
|
| L. Popovich
|
| Vol #:
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| 4
|
| |
|
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| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 694
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| T. Lampe
|
| Vol #:
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| 10
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| |
|
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| EMC 695
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| The Platinum Group
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| Vol #:
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| 10
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| EMC 696
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| Calorie Control Council
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| Vol #:
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| 10
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| EMC 697
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| R. Blaylock
|
| Vol #:
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| 10
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| |
|
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| EMC 698
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| M. Richard-Calkins
|
| Vol #:
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| 10
|
| |
|
|
| 2003E-0256
|
| Patent Extension for Ranexa (ranolazine), 4,567,264
|
| |
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0407
|
| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
|
| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
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| EMC 1338
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| M. Mont
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| Vol #:
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| 12
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|
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| EMC 1339
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| C. & M. Richards
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| Vol #:
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| 12
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|
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| EMC 1340
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| K. Lewis
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| Vol #:
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| 12
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|
| | | | | | | | |
|
|
|
| 2004E-0307
|
| Patent Extension for ALIMTA (pemetrexed), U.S. Patent No. 5,344,932
|
| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0394
|
| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
|
| |
|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
| |
|
|
| EMC 2
|
| P. Carr
|
| Vol #:
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| 3
|
| |
|
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| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| EMC 3862
|
| J. Stauffer
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| Vol #:
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| 195
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| EMC 3863
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| L. Troop
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| Vol #:
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| 195
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| EMC 3864
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| J. Erickson
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| Vol #:
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| 195
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| EMC 3865
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| K. Searle
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| Vol #:
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| 195
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| EMC 3866
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| D. Wilhelm
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| Vol #:
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| 195
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| EMC 3867
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| J. Glendenning
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| Vol #:
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| 195
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| EMC 3868
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| L. Irwin
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| Vol #:
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| 195
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| EMC 3869
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| C. Symington
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| Vol #:
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| 195
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| EMC 3870
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| S. Lambert
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| Vol #:
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| 195
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| EMC 3871
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| P. Hanaford
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| Vol #:
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| 195
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| EMC 3872
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| M. Branson
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| Vol #:
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| 195
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| |
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| EMC 3873
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| K. Ames
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| Vol #:
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| 195
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| EMC 3874
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| H. Christensen
|
| Vol #:
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| 195
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| EMC 3875
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| J. Gallucci
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| Vol #:
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| 195
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| EMC 3876
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| K. Tisko
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| Vol #:
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| 195
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| |
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| EMC 3877
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| N. Niss
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| Vol #:
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| 195
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| |
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| EMC 3878
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| J. Stull
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| Vol #:
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| 195
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| |
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| EMC 3879
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| L. Martin
|
| Vol #:
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| 195
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| |
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| EMC 3880
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| R. Bello
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| Vol #:
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| 195
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| |
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| EMC 3881
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| J. Burrows
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| Vol #:
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| 195
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| |
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| EMC 3882
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| Y. Kim
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| Vol #:
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| 195
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| |
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| EMC 3883
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| D. Lanoue
|
| Vol #:
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| 195
|
| |
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| EMC 3884
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| D. Therese
|
| Vol #:
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| 195
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| |
|
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| EMC 3885
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| E. Alameda
|
| Vol #:
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| 195
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| |
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| EMC 3886
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| Y. Bruckner
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| Vol #:
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| 195
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| |
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| EMC 3887
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| J. Taylor
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| Vol #:
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| 195
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| |
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| EMC 3888
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| A. Artwohl
|
| Vol #:
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| 195
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| | | | | | | | |
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| |
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| EMC 3889
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| D. Kladerman
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| Vol #:
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| 195
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| |
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| EMC 3890
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| A. Gemoll
|
| Vol #:
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| 195
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| |
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| EMC 3891
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| L. Montgomery
|
| Vol #:
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| 195
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| |
|
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| EMC 3892
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| S. Mausner
|
| Vol #:
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| 195
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| |
|
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| EMC 3893
|
| L. VanAtta
|
| Vol #:
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| 195
|
| |
|
|
| EMC 3894
|
| S. Tolle
|
| Vol #:
|
| 195
|
| |
|
|
| 2006E-0260
|
| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0282
|
| Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319
|
| |
|
|
| LET 3
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0354
|
| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0355
|
| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2006E-0356
|
| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
|
| |
|
|
| LET 2
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0292
|
| Unique Device Identification
|
| |
|
|
| EC 17
|
| tesa tape, inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| EC 53
|
| Dr. William Duncan
|
| Vol #:
|
| 3
|
| |
|
|
| EC 54
|
| Mr. James Abdu
|
| Vol #:
|
| 3
|
| |
|
|
| EC 55
|
| None
|
| Vol #:
|
| 3
|
| |
|
|
| EC 56
|
| self
|
| Vol #:
|
| 3
|
| |
|
|
| EC 57
|
| Mr. James Hayes
|
| Vol #:
|
| 3
|
| |
|
|
| EC 58
|
| Mrs. Laura Hiler
|
| Vol #:
|
| 3
|
| |
|
|
| EC 59
|
| Nationall Licensed Certified Nutritionist (CN)
|
| Vol #:
|
| 3
|
| |
|
|
| EC 60
|
| Women's Voices for the Earth
|
| Vol #:
|
| 3
|
| |
|
|
| 2006P-0101
|
| Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
|
| |
|
|
| LET 1
|
| FDA/CFSAN to Macfarlane Ferguson & McMullen
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
| |
|
|
| EC 17
|
| Ordway Research Institute Drug Development Center
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2006P-0263
|
| ANADA suitability for Neomycin
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0265
|
| to permit an ANDA Suitability for Cefdinir
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0267
|
| ANDA Suitability for Dextroamphetamine Sulfate Tablets
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0281
|
| Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0285
|
| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0311
|
| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
|
|
|
|
|
|
|
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0313
|
| Removal of labeling for MediSense Precision Advanced Diabetes Management System
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0316
|
| Health Claim: Phyposterols and Reduced Risk of Coronary Heart Disease
|
| |
|
|
| C 1
|
| D Lowe
|
| Vol #:
|
| 3
|
| |
|
|
| 2006P-0369
|
| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
|
| |
|
|
| ACK 1
|
| FDA/DDM to Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0370
|
| Revoke FDA's prior approval of vagus nerve stimulation (VNS) for mangement of treatment-resistant depression (TRD)
|
| |
|
|
| ACK 1
|
| FDA/DDM to Public Citizen
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Public Citizen
|
| Vol #:
|
| 1
|
|
|
