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| Dockets Entered
On November 21, 2005
Table of Contents
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| Docket #
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| Title
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| 1991P-0175
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| Common or Usual name for Processed Euchema Seaweed
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| 1993V-0315
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| Laser Light Show
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 2000V-1442
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| Laser Light Show
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0470
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| Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0205
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| Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture
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| 2005P-0242
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| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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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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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 1991P-0175
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| Common or Usual name for Processed Euchema Seaweed
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| LET
5
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| Hercules Incorporated
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| Vol #:
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| 9
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| WDL
1
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| CP Kelco US, Inc.
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| Vol #:
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| 9
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| 1993V-0315
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| Laser Light Show
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| VRA
5
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| HFZ-240 to Laser Display Assoicates, Inc.
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| Vol #:
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| 1
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| MM
1
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| Meeting between FDA and Council for Responsible Nutrition
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| Vol #:
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| 43
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| 2000V-1442
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| Laser Light Show
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| VRA
2
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| HFZ-240 to Yamagata Studio
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| Vol #:
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| 1
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| C
39
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| American Association for Clinical Chemistry (AACC)
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| Vol #:
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| 3
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C 73
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| V. Sternadore
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| Vol #:
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| 17
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| C 74
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| S. Zackley
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| Vol #:
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| 17
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| C 75
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| B. Carra
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| Vol #:
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| 17
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| C 76
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| B. Norris
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| Vol #:
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| 17
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| C 77
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| M. Dietz
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| Vol #:
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| 17
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| C 78
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| J. Bradford
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| Vol #:
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| 17
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| C 79
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| P. Simcueau
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| Vol #:
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| 17
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| C 80
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| D. Adams
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| Vol #:
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| 17
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| C 81
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| G. Leary
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| Vol #:
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| 17
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| C 82
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| J. Canzoneri
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| Vol #:
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| 17
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| C 83
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| A. Taylor
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| Vol #:
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| 17
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| C 84
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| K. Taylor
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| Vol #:
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| 17
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| C 85
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| Form Letters
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| Vol #:
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| 18
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| C 86
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| E. Kremer
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| Vol #:
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| 17
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| C 87
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| M. Taylor
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| Vol #:
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| 17
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| C 88
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| L. Lopez
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| Vol #:
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| 17
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| C 89
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| I. Pelaxo
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| Vol #:
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| 17
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| C 90
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| J. Iglesias
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| Vol #:
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| 17
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| C 91
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| Form letters
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| Vol #:
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| 19
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| C 92
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| Form Letters
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| Vol #:
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| 20
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| C
2
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals
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| Vol #:
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| 1
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C
2
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| Aultman Hospital, Department of Pathology
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| Vol #:
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| 1
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| 2005D-0470
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| Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)
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| C
1
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| Feminine Hygiene Task Force
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| Vol #:
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| 1
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 490
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| H and F Eisser
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| Vol #:
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| 165
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| C 491
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| M. Herron
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| Vol #:
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| 165
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| C 492
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| Illegible
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| Vol #:
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| 165
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| C
1
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| Fleminger, Inc.
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| Vol #:
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| 1
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| C
2
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| American College of Preventive Medicine et al.
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| Vol #:
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| 1
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| C
3
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 1
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| C 8
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| C. Becker
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| Vol #:
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| 2
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| 2005P-0205
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| Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture
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| LET
1
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| HFD-005 to Office of Illinois Attorney General
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| Vol #:
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| 1
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| 2005P-0242
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| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
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| AMD
2
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| Samson Medical Technologies, LLC
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| Vol #:
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| 1
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP
1
Attachment
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| Department of the Planet Earth
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| Vol #:
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| 3
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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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| C
5
Attachment
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| North American Menopause Society (NAMS)
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| Vol #:
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| 1
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| C
6
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| American Society for Reproductive Medicine
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| Vol #:
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| 1
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| 2005P-0418
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| Dextroamphetamine sulfate tablets, 2.5 mg,7.5 mg,15 mg,20 mg, and 30 mg suitable for submission as an ANDA
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| WDL
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| C 3
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| R. Gray, MD, FASAM
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| Vol #:
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| 1
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