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| Dockets Entered
On September 26, 2006
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| Docket #
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| Title
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| 1978P-0173
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| LASERIUM CONCERT SYSTEM
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| 1990V-0031
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| Lasermedia Series Projectors, Spectra Phycis Series Lasers
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| 1992V-0331
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| Laser Light Show
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| 1998D-0965
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| Uniform Labeling of Blood/Blood Components using ISBT 128
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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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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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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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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| 2006N-0357
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
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| 2006P-0144
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| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 1978P-0173
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| LASERIUM CONCERT SYSTEM
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| VRA 14
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| FDA/CDRH to Laser Images, Inc.
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| Vol #:
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| 1
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| 1990V-0031
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| Lasermedia Series Projectors, Spectra Phycis Series Lasers
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| VRA 8
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| FDA/CDRH to Laser Rentals, Inc.
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| 1
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| 1992V-0331
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| Laser Light Show
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| VRA 7
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| FDA/CDRH to Advanced Entertainment Technologies
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| Vol #:
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| 1
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| 1998D-0965
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| Uniform Labeling of Blood/Blood Components using ISBT 128
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| GDL 3
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| Guidance
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| Vol #:
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| 2
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| RPT 1
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| United States Industry consensus Standard for the Uniform Labeling of Blood and Blood Components
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| Vol #:
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| 2
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| | | | | | | | |
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| N 1
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| FDA
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| Vol #:
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| 5
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 25
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| Mr. Frank Gomez
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| Vol #:
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| 8
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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| GDL 4
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| Guidance
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| Vol #:
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| 1
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| NAD 4
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| FDA
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| Vol #:
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| 1
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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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| EC 1
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| Compressed Gas Association
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| Vol #:
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| 3
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
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| C 3
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| National Alliance on Mental Illness (NAMI)
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| Vol #:
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| 5
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| EC 1
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| New York Presbyterian
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| Vol #:
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| 1
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| EC 2
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| New York Presbyterian
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| Vol #:
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| 1
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| EC 1
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| french health products safety agency
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| Vol #:
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| 1
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| N 2
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| FDA
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| Vol #:
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| 2
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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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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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| C 1
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| V. Zachary
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| Vol #:
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| 1
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| C 2
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| Straus-Edwards Associates Architects
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| Vol #:
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| 1
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| C 3
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| Form Letters
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| Vol #:
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| 2
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| NM 3
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| FDA
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| Vol #:
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| 1
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| C 1
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| AMerican Osteopathic Association (AOA)
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 21
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| River Falls Area Hospital
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| Vol #:
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| 1
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| EC 22
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| River Falls Area Hospital
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| Vol #:
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| 1
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| EC 23
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| River Falls Area Hospital
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| Vol #:
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| 1
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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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| C 32
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| 72 signatures
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| Vol #:
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| 7
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| 2006N-0357
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
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| N 1
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| FDA
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| Vol #:
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| 1
|
|
|
|
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| 2006P-0144
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| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
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|
|
|
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| LET 1
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| FDA/CDER to Custopharm, Inc.
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 724
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| Ms. Kathryn Lee
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| Vol #:
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| 3
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| EC 725
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| Mrs. Lana Beckley
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| Vol #:
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| 3
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| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 709
|
| Mr. Rob Waters
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| Vol #:
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| 5
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