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| Dockets Entered On March 12, 2007
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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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| 1999E-0117
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| Patent Extension Heart Laser, # 5,125,926
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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| 2001E-0365
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| Patent Term Extension Application, NEXIUM 4,738,974
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2006D-0504
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| Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| 2006P-0372
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| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2007A-0087
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| Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007V-0088
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| Projector for a Laser Light Show
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| C 93
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| Lanxess Corporation
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| Vol #:
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| 203
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| 1999E-0117
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| Patent Extension Heart Laser, # 5,125,926
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2001E-0365
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| Patent Term Extension Application, NEXIUM 4,738,974
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| LET 7
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 362
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| B. Goode
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| Vol #:
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| 32
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| C 363
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| R. Sawdon
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| Vol #:
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| 32
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| C 364
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| C. Cruz
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| Vol #:
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| 32
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| C 365
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| N. Merjian
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| Vol #:
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| 32
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| C 544
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| L. Hindin
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| Vol #:
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| 11
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| C 545
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| J. Crouch
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| Vol #:
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| 11
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| C 546
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| number not used
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| Vol #:
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| 11
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| C 547
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| number not used
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| Vol #:
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| 11
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| C 548
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| number not used
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| Vol #:
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| 11
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| 2006D-0504
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| Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
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| C 1
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| Nihon Kohden America Inc
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| Vol #:
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| 1
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 2
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| NFR 2
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| FDA
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| Vol #:
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| 1
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| 2006P-0372
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| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
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| LET 1
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| FDA/CDER to Lachman Consultant Services, Inc
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| Vol #:
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| 1
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| 2007A-0087
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| Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling
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| ACK 1
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| FDA/DDM to WileyRein LLP
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| Vol #:
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| 1
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| AP 1
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| WileyRein LLP
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| Vol #:
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| 1
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| 2007E-0066
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| Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| ACK 1
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| FDA/DDM to GMA/FPA
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| Vol #:
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| 1
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| CP 1
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| Grocery Manufacturers Association
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| Vol #:
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| 1
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| MT 1
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| Telephone Conversation between FDA and GMA/FPA
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| Vol #:
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| 2
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| 2007V-0088
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| Projector for a Laser Light Show
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| ACK 1
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| FDA / DDM to Platinum Graphics
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| Vol #:
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| 1
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| VAR 1
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| Platinum Graphics
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| Vol #:
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| 1
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