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| Dockets Entered
On November 30, 2007
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| Docket #
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| Title
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| 1976N-0052T
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| OTC ANTITUSSIVES
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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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-0017
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| Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006D-0480
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| Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2006P-0291
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| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| 2007D-0212
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| Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
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| 2007N-0277
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| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
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| 2007N-0323
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007P-0062
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| Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| 2007P-0465
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| Review Labeling and Bioequivalence Standards for Felodipine Extended-Release Tablets to Incorporate Safety Information and Ensure Equivalent Product Safety and Effectiveness
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| 2007P-0466
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| Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
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| 1976N-0052T
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| OTC ANTITUSSIVES
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| NFR 3
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| FDA
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| Vol #:
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| 8
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| 1978N-0038
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| Sunscreen Drug Products
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| C 694
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| L'Oreal, USA
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| Vol #:
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| 171
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| EC 2708
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| Mrs. Rebecca Wilson
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| Vol #:
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| 170
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| EC 2709
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| Ms. Karen Walsh
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| Vol #:
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| 170
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| EREG 13
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| G. Kimbrell
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| Vol #:
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| 170
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| EREG 14
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| K. Markey
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| Vol #:
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| 170
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| EREG 15
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| J. Mayo
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| Vol #:
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| 170
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| EREG 16
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| B. Sachau
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| Vol #:
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| 170
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| | | | | | | |
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| LET 21141
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21142
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21143
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21144
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21145
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21146
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21147
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21148
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21149
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21150
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| NBTY
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| Vol #:
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| 182
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| LET 21151
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21152
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21153
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| NBTY
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| Vol #:
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| 182
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| |
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| LET 21154
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| NBTY
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| Vol #:
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| 182
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| LET 21155
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| NBTY
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| Vol #:
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| 182
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| LET 21156
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21157
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21158
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21159
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21160
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21161
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21162
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21163
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21164
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21165
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21166
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21167
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21168
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21169
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| NBTY, Inc.
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| Vol #:
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| 182
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| LET 21170
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| NBTY, Inc.
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| Vol #:
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| 182
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| |
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| LET 21171
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| NBTY, Inc.
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| Vol #:
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| 182
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| |
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| LET 21172
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| NBTY, Inc.
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| Vol #:
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| 182
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| |
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| LET 21173
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| NBTY, Inc.
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| Vol #:
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| 182
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| |
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| LET 21174
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| Metagencies
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| Vol #:
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| 182
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| |
|
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| LET 21175
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
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| LET 21176
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
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| LET 21177
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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|
| | | | | | | | |
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| LET 21178
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
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| LET 21179
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
|
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| LET 21180
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
|
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| LET 21181
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
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| LET 21182
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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| |
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| LET 21183
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| Perrigo Company of South Carolina
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| Vol #:
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| 182
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|
| 2005D-0019
|
| 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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|
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| |
|
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| |
|
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| REF 1
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| References
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| Vol #:
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| 1
|
| |
|
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| 2005N-0017
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| Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
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|
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|
|
|
| | |
|
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| NFR 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| |
|
|
| EC 9
|
| Dr. Thomas Stout
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| Vol #:
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| 1
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| EC 10
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| Concerned Father/Citizen
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| Vol #:
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| 1
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| |
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| EC 11
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| N/A
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| Vol #:
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| 1
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| EC 12
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| Cambridge Food Control Ltd
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| Vol #:
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| 1
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| |
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| EC 13
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| Mr. Daniel Karlin
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| Vol #:
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| 1
|
|
| |
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| 2006D-0480
|
| Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
|
| |
|
|
| C 1436
|
| National Solutions Foundation
|
| Vol #:
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| 61
|
| |
|
|
| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
|
| |
|
|
| EREG 3
|
| J. Cybulski
|
| Vol #:
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| 1
|
| |
|
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| 2006P-0291
|
| Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| |
|
|
| LET 2
|
| Elizabeth Sadove
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| Vol #:
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| 1
|
| |
|
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| 2006P-0298
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| To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
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| |
|
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| LET 2
|
| Janet Woodcock
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| Vol #:
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| 1
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| |
|
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| 2006P-0299
|
| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| |
|
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| LET 2
|
| Elizabeth Sadove
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| Vol #:
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| 1
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| |
|
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| 2006P-0309
|
| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| |
|
|
| LET 2
|
| Elizabeth Sadove
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| Vol #:
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| 1
|
|
| | | | | | | | |
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| |
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| 2006P-0508
|
| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| |
|
|
| C 2
|
| Charles Weber
|
| Vol #:
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| 1
|
| |
|
|
| 2007D-0212
|
| Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
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| |
|
|
| C 4
|
| D. Jaffe
|
| Vol #:
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| 1
|
|
| |
|
| 2007N-0277
|
| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
|
| |
|
|
| NEC 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2007N-0323
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| |
|
|
| N 2
|
| FDA
|
| Vol #:
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| 1
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| |
|
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| |
|
|
| EC 109
|
| Cooper Research, Inc.
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| Vol #:
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| 2
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| |
|
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| EC 110
|
| Dr. William Cartmill
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| Vol #:
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| 2
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| |
|
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| EC 111
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| American Academy of Family Physicians
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| Vol #:
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| 2
|
| |
|
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| LST 1
|
| Agenda of November 14, 2007 Public Meeting
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| Vol #:
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| 3
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| |
|
|
| TS 1
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| American Society of Health-System Pharmacists
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| Vol #:
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| 3
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| |
|
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| TS 2
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| American College of Clinical Pharmacy
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| Vol #:
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| 3
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| |
|
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| TS 3
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| American Pharmacists Association
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| Vol #:
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| 3
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| |
|
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| TS 4
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| University of California San Francisco School of Phamacy
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| Vol #:
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| 3
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| |
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| TS 5
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| St. John's University
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| Vol #:
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| 3
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| |
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| TS 6
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| Samford University
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| Vol #:
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| 3
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| |
|
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| TS 7
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| UCLA
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| Vol #:
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| 3
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| |
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| TS 8
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| Consumer Healthcare Products Association
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| Vol #:
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| 3
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| |
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| TS 9
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| Health Canada
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| Vol #:
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| 3
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| |
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| TS 10
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| Mount Sinai School of Medicine
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| Vol #:
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| 3
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| |
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| TS 11
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| National Alliance of State Pharmacy Associations
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| Vol #:
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| 3
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| |
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| TS 12
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| University of Pittsburgh
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| Vol #:
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| 3
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| |
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| TS 13
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| McNeil Consumer Healthcare
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| Vol #:
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| 3
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| |
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| TS 14
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| J. Richard Crout, M.D.
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| Vol #:
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| 3
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| |
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| TS 15
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| Mann Healthcare Ltd
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| Vol #:
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| 3
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| |
|
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| TS 16
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| Francesco International
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| Vol #:
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| 3
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| |
|
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| TS 17
|
| GlaxoSmithKline
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| Vol #:
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| 3
|
|
| |
|
| 2007P-0062
|
| Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
|
|
|
|
|
|
|
| |
|
|
| LET 1
|
| Elizabeth Sadove
|
| Vol #:
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| 1
|
| |
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
| | | | | | | | |
|
| |
|
| EC 145
|
| Mr. Bill Moore
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0438
|
| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
|
|
|
|
|
|
| | |
|
|
| EC 9
|
| Ms. Lois Davidson
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| Founder of the MCS
Beacon of Hope Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 11
|
| Co-Founder of the MCS
Beacon of Hope Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| MCS Beacon of Hope Foundation
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0465
|
| Review Labeling and Bioequivalence Standards for Felodipine Extended-Release Tablets to Incorporate Safety Information and Ensure Equivalent Product Safety and Effectiveness
|
| |
|
|
| ACK 1
|
| FDA to United Research Laboratories, Inc. Mutual Pharmaceutical Company, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| United Research Laboratories, Inc. Mutual Pharmaceutical Company, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0466
|
| Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
|
| |
|
|
| ACK 1
|
| FDA/DDM to Medicure Pharma
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Medicure Pharma
|
| Vol #:
|
| 1
|
|
|
