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| Dockets Entered
On January 22, 2007
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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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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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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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-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0535
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| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
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| 2007P-0022
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| ANDA Suitability Petition for Oral Transmucosal Fentanyl Citrate
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| 2007P-0028
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| Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
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| 2007P-0030
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| ANDA Suitability for Acetaminophen 400 mg, Butalbital 50 mg and Caffeine 40 mg Capsules
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 586
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| Ms. Mary Scott
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| Vol #:
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| 19
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| EC 587
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| AMERICAN NURSES ASSOCIATION
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| Vol #:
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| 19
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| EC 588
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| Sabine Studios
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| Vol #:
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| 19
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| EC 589
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| Ms. Maureen Dailey
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| Vol #:
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| 19
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| EC 590
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| Ms. Amy Kendall
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| Vol #:
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| 19
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| EC 591
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| Ms. Beverly Skrabut
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| Vol #:
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| 19
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| EC 592
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| Mrs. Susan Rosado
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| Vol #:
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| 19
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| EC 593
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| Miss. Lynn Breaux
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| Vol #:
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| 19
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| EC 594
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| Ms. Linda Harvey
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| Vol #:
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| 19
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| EC 595
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| Ms. kim west
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| Vol #:
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| 19
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| EC 596
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| Ms. Debbi Whitman
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| Vol #:
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| 19
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| EC 597
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| Ms. Donna Lynch
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| Vol #:
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| 19
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| EC 598
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| Mrs. Karen Bowes
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| Vol #:
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| 19
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| EC 599
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| Ms. Valerie Tukey
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| Vol #:
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| 19
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| EC 600
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| Mrs. Debra Haynes
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| Vol #:
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| 19
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| EC 601
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| Ms. Crystal Harmon
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| Vol #:
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| 19
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| EC 602
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| Mrs. Terri Galvin
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| Vol #:
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| 19
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| EC 603
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| Ms. Candice Sexton
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| Vol #:
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| 19
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| EC 604
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| Dr. Barbara Solomon
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| Vol #:
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| 19
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| EC 605
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| Mrs. Juliana St. Helene-Kraft
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| Vol #:
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| 19
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| EC 606
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| Ms. Sue Curtis
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| Vol #:
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| 19
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| EC 607
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| Mrs. Melissa Pfannenstiel
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| Vol #:
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| 19
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| EC 608
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| Miss. Jennifer Reid
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| Vol #:
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| 19
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| EC 609
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| Mrs. Elizabeth Perry
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| Vol #:
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| 19
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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 37
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| Mrs. Susan Sellers
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| Vol #:
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| 8
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| EC 38
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| Ms. Casey Tims
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| Vol #:
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| 8
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 81
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| J. Dryden
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| Vol #:
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| 9
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| C 82
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| F. Myers
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| Vol #:
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| 9
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| C 83
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| M. Evans
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| Vol #:
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| 9
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| C 84
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| V. Henderson
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| Vol #:
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| 9
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| C 85
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| Markoniske
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| Vol #:
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| 9
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| C 86
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| K. Calzetti
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| Vol #:
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| 9
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| C 87
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| T. Frakes
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| Vol #:
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| 9
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| C 88
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| R. Pearl
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| Vol #:
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| 9
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 18
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| Dr. Anony Mous
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| Vol #:
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| 1
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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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 13
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| SPL Working Group
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| Vol #:
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| 3
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| EC 14
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| Advanced Medical Technology Association
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| Vol #:
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| 3
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| WDL 1
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| Medi-Flex Inc.
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| Vol #:
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| 1
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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| EC 1
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| Ms. Deborah Berchem
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| Vol #:
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| 3
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| 2006P-0302
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| Permit the filing of an ANDA Suitability for Sodium Chloride Injection
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| SUP 1
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| Beckloff Associates, Inc.
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| Vol #:
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| 1
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| C 44
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| H. P. McElrath
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| Vol #:
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| 5
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| EC 882
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| Ms. Cynthia Robinson
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| Vol #:
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| 4
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| EC 883
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| Ms. Anne Steinberg
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| Vol #:
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| 4
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| EC 884
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| n/a
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| Vol #:
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| 4
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| EC 885
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| Ms. Charlene Mayfield
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| Vol #:
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| 4
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| WDL 1
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| Number not used
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| Vol #:
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| 1
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| 2006P-0535
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| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
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| EC 29
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| Mrs. Karla Raasio
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| Vol #:
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| 3
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| EC 30
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| Mrs. Debbie Bailey
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| Vol #:
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| 3
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| 2007P-0022
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| ANDA Suitability Petition for Oral Transmucosal Fentanyl Citrate
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2007P-0028
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| Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
|
|
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2007P-0030
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| ANDA Suitability for Acetaminophen 400 mg, Butalbital 50 mg and Caffeine 40 mg Capsules
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| ACK 1
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| FDA/ DDM to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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