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| Dockets Entered
On August 24, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0117
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| Human Drugs Patent Term
Extension & New Patents
|
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
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| 1999F-4372
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| National Fisheries Institute
and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection
service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for
the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control
of Food-borne pathogens safe use
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| 1999P-5106
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| Identify Sources of
Natural Flavorings
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2000V-1333
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| Laser Pro Projector
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| 2001F-0047
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| Foodborne pathogens
in raw-frozen-cooked-partially cooked
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| 2001P-0034
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| Restaurant Foods Containing
Methylcellulose or Carrageenin
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2001V-0138
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| Q-Beam series for a
laser light show and projectors
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| 2002N-0278
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| Bioterrorism; Prior
Notice of Imported Food Shipments
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| 2002V-0283
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| Laser Light Show
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| 2002V-0286
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| Laser light show
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|
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| 2003D-0391
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| Guidance for Industry
and FDA Staff; Class II Special Controls Guidance Document: Dental Precious
Metal Alloys and Class II Special Controls Guidance Document: Dental
Base Metal Alloys
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|
|
|
| 2003D-0571
|
| Guidance for Industry
on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2003N-0342
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| Toll-Free Number for
Reporting Adverse Events on Labeling for Human Drug Products
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| 2003N-0390
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| Dental Devices; Gold
Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation
of Special Controls
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| 2003P-0029
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| Remove metered-dose
inhalers (MDI) containing moiety albuter
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| 2003P-0453
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| Abbreviated new drug
applications (ANDAs) suitability for hydrocodone bitartrate
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|
|
| 2003P-0544
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| Modify existing food
additive regulation with respect to the irradiation of ground beef byproducts
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|
|
| 2003P-0548
|
| Determination whether
Dexamethasone Acetate Injection withdrawn for Safety Reasons
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|
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| 2003P-0555
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| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
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| 2003P-0574
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| Regulatory limit for
Listeria monocytogenes in ready-to-eat foods that do not support its
growth
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|
|
|
| 2003V-0374
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| Laser Light Show
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|
|
|
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| 2003V-0484
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| Laser Light Show
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|
|
| 2004D-0042
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| Guidances for Industry
on Improving Direct-to-Consumer Advertising for Medical Products
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| 2004D-0193
|
| Guidance for Industry:
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
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|
|
|
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| 2004D-0198
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| Guidance for Industry:
Acceptable Full-Length Donor History Questionnaire and Accompanying
Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004D-0352
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| Global Harmonization
Task Force, Study Groups 1 and 2; New Proposed Documents
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| 2004N-0018
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| Human Subject Protection;
Foreign Clinical Studies Not Conducted Under an Investigational New
Drug Application
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| 2004N-0081
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| BSE Risk Materials in
Foods and Cosmetics
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| 2004N-0194
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| DEFINITION OF PRIMARY
MODE OF ACTION OF A COMBINATION PRODUCT
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| 2004N-0254
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| Possible Barriers to the Availability
of Medical Devices Intended to Treat or Diagnose Diseases and Conditions
that Affect Children
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| 2004N-0330
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| Suicidality in Clinical
Trials for Antidepressant Drugs in Pediatric Patients
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| 2004N-0346
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| Over-the-Counter Drug
Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient
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| | | | | | | | |
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| 2004N-0375
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| Number not used
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| 2004P-0009
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| to clarify the use of the terms "100% Natural" and "Fat Free" in food product packages
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| |
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0060
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| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
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| 2004P-0070
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| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0088
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| Petition to modify requirements for prescription/non prescription drug labeling
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| 2004P-0376
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| ANADA for a feneric intravaginal progesterone insert for cattle that differs from the pioneer product
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| 2004V-0119
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| Laser Light Show
|
|
|
|
|
| 1995S-0117
|
| Human Drugs Patent Term Extension & New Patents
|
|
|
|
|
| LST
94
|
| List as of June 30, 2004
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| Vol #:
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| 7
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|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
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|
| LET
14418
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| Leiner Health Products
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| Vol #:
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| 126
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| LET
14419
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| Leiner Health Products
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| Vol #:
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| 126
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| LET
14420
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| Leiner Health Products
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| Vol #:
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| 126
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| LET
14421
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| Physician Health Network
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| Vol #:
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| 126
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| LET
14422
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| Jarrow Formulas
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| Vol #:
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| 126
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| LET
14423
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| Jarrow Formulas
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| Vol #:
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| 126
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| LET
14424
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| Jarrow Formulas
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| Vol #:
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| 126
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| LET
14425
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| Jarrow Formulas
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| Vol #:
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| 126
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| LET
14426
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| Jarrow Formulas
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| Vol #:
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| 126
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| LET
14427
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| Jarrow Formulas
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| Vol #:
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| 126
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| LET
14428
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| Source Naturals
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| Vol #:
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| 126
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| LET
14429
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| The Daily Wellness Company
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| Vol #:
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| 126
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| LET
14430
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| Source Naturals
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| Vol #:
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| 126
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| LET
14431
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| Source Naturals
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| Vol #:
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| 126
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| LET
14432
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| Source Naturals
|
| Vol #:
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| 126
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|
|
|
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| LET
14433
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| Source Naturals
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| Vol #:
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| 126
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|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| C
80
|
| Center for Food Safety
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5321
|
| Food Safety & Inspection service safe use of ionizing radiai
|
|
|
|
|
| C
78
Enclosure
|
| Center for Food Safety
|
| Vol #:
|
| 8
|
|
|
|
|
| 1999F-5322
|
| Ionizing Radiation for the Treatment of Food
|
|
| | | | | | | | |
|
|
|
|
| C
77
|
| Center for Food Safety
|
| Vol #:
|
| 6
|
|
|
|
|
| 1999F-5522
|
| Ionizing radiation /control of Food-borne pathogens safe use
|
|
|
|
|
| C
81
|
| Center for Food Safety
|
| Vol #:
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| 6
|
|
|
|
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| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
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|
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| C 59
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| E. Hahn
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| Vol #:
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| 3
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| C 60
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| Eligible
|
| Vol #:
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| 3
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| C 61
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| B. Rand
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| Vol #:
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| 3
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| C 62
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| J. Kemmerer
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| Vol #:
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| 3
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| C 63
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| Eligible
|
| Vol #:
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| 3
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| C 64
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| R. Allen
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| Vol #:
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| 3
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| C 65
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| A. Choren
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| Vol #:
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| 3
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EXB 479
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 480
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
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| EXB 481
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
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| EXB 482
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
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| EXB 483
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
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| EXB 484
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 485
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 486
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 487
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 488
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 489
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 490
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 491
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 492
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 493
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 494
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 495
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| EXB 496
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 431
|
|
|
|
|
| 2000V-1333
|
| Laser Pro Projector
|
|
|
|
|
| VRA
2
|
| HFZ-300 to Falls Park Sound and Light, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
|
|
|
|
| C
76
Enclosure
|
| Center for Food Safety
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
|
|
|
| 2001P-0034
|
| Restaurant Foods Containing Methylcellulose or Carrageenin
|
|
|
|
|
| PDN
1
|
| HFC-1 to Ruth Armstrong
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 2020
|
| 32 signatures
|
| Vol #:
|
| 289
|
|
|
|
|
| 2001V-0138
|
| Q-Beam series for a laser light show and projectors
|
|
|
|
|
| VRA
2
Attachment A,
B
|
| HFZ-300 to DJ Tony
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C
365
|
| Transat Trade Company
|
| Vol #:
|
| 30
|
|
|
|
|
| 2002V-0283
|
| Laser Light Show
|
|
|
|
|
| VRA
2
Attachment A,
B
|
| HFZ-300 to International Laser and Light, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002V-0286
|
| Laser light show
|
|
|
|
|
| VRA
2
Attachment A,
B
|
| HFZ-300 to Adams Audio Laboratories Laser Division
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0391
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys
|
|
|
|
|
|
|
|
|
| GDL
3
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
|
|
| C
30
|
| Chemagis, Ltd.
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003N-0342
|
| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
|
|
|
|
|
| C
10
|
| Longs Drug Stores California, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0390
|
| Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
|
|
|
| C
26
|
| SC Sivel
|
| Vol #:
|
| 5
|
|
|
|
|
| C
27
|
| Asthma Therapy Coalition (ATC)
|
| Vol #:
|
| 5
|
|
|
|
|
| C 28
|
| R. Carlson
|
| Vol #:
|
| 5
|
|
|
|
|
| C
29
|
| Honeywell International Inc.
|
| Vol #:
|
| 5
|
|
|
|
|
| C
30
|
| Rite Aid Corporation (Rite Aid)
|
| Vol #:
|
| 5
|
|
|
|
|
| C
31
|
| Schering-Plough
|
| Vol #:
|
| 5
|
|
|
|
|
| 2003P-0453
|
| Abbreviated new drug applications (ANDAs) suitability for hydrocodone bitartrate
|
|
| | | | | | | | |
|
|
|
|
| AMD
1
|
| King & Spalding LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
|
|
| C
37
Attachment
|
| Center for Food Safety
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0548
|
| Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
|
|
|
| C
23
|
| Protection & Advocacy, Inc. (PAI)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
|
|
| C
6
|
| Schwan Food Company
|
| Vol #:
|
| 2
|
|
|
|
|
| C
7
|
| Institute of Food Technologists (IFT)
|
| Vol #:
|
| 2
|
|
|
|
|
| C
8
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003V-0374
|
| Laser Light Show
|
|
|
|
|
| VRA
2
|
| HFZ-300 to Beaming Man
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003V-0484
|
| Laser Light Show
|
|
|
|
|
| VRA
1
Attachment A,
B
|
| HFZ-300 to Pulslight Co.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
|
|
| C
30
|
| Bayer Pharmaceuticals Corporation (Bayer)
|
| Vol #:
|
| 3
|
|
|
|
|
| C
31
|
| Medtronic Neurological
|
| Vol #:
|
| 3
|
|
|
|
|
| C
32
|
| Catalina Health Resource (CHR)
|
| Vol #:
|
| 3
|
|
|
|
|
| C
33
|
| Advanced Medical Technology Assn (AdvaMed)
|
| Vol #:
|
| 3
|
|
|
|
|
| C
34
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| C
4
|
| National Marrow Donor Program (NMDP)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| Community Blood Center/Community Tissue Services (CBC/CTS)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
6
|
| Midwest eye Banks and Transplantation Center (MEBTC)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
7
|
| Laboratories At Bonfils
|
| Vol #:
|
| 1
|
|
|
|
|
| C
8
|
| Eye Bank Assn of America (EBAA)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
9
|
| American Assn of Tissue Banks (AATB)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
10
|
| ReroTech Limited
|
| Vol #:
|
| 1
|
|
|
|
|
| C
11
|
| Cryogenic Laboratories, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C
12
|
| American Society for Repoductive Medicine (ASRM)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0198
|
| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
|
|
| | | | | | | | |
|
|
|
|
| C
5
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0352
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| Global Harmonization Task Force, Study Groups 1 and 2; New Proposed Documents
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| BKG
1
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| Background
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| Vol #:
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| 1
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| BKG
2
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| Background
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| C
1
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| Aventis Pharmaceuticals
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C
4
Exhibits
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| Lafarage North America, Inc. (Lafarge)
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| Vol #:
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| 1
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| C
5
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| Embassy of Australia
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| Vol #:
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| 1
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| C
2
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| Abbott Laboratories
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| Vol #:
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| 1
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| C
3
Attachment
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
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| C
4
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| American Medical Systems (AMS)
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| Vol #:
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| 1
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| C
5
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| Cook Group, Inc.
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| Vol #:
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| 1
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| C
6
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| Combination Products Coalition (CPC)
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| Vol #:
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| 1
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| C
7
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| Medtronic Neurological
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| Vol #:
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| 1
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| C
8
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| Wyeth Pharmaceuticals, Inc. (Wyeth)
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| Vol #:
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| 1
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| C
9
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| Smith & Nephew Wound Management
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| Vol #:
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| 1
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| C
10
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| Combination Products Coalition (CPC)
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| Vol #:
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| 1
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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|
| EC 5
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| Mrs. Patricia Tierney
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| Vol #:
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| 1
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| EC 6
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| Cryonic Life Insurance Company
|
| Vol #:
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| 1
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| EC
7
|
| University of Florida College of Medicine
|
| Vol #:
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| 1
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|
| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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| NCR
1
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| FDA
|
| Vol #:
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| 1
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| 2004N-0346
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient
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| BKG
1
|
| Background
|
| Vol #:
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| 1
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| NRD
1
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| FDA
|
| Vol #:
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| 1
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| 2004N-0375
|
| Number not used
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| CP 1
|
| number not used
|
| Vol #:
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| 1
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|
|
|
|
| 2004P-0009
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| to clarify the use of the terms "100% Natural" and "Fat Free" in food product packages
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|
| | | | | | | | |
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| LET
1
|
| HFS-800 to Antonio Zamora
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| Vol #:
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| 1
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|
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| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
|
|
| EXT
1
|
| Weider Nutrition International, Inc.
|
| Vol #:
|
| 13
|
|
|
|
|
| LET
8
|
| HFS-830
|
| Vol #:
|
| 13
|
|
|
|
|
| 2004P-0060
|
| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
|
|
|
|
|
| EXT
1
|
| Rotta Pharmaceuticals, Inc. (Rotta)
|
| Vol #:
|
| 3
|
|
|
|
|
| LET
8
|
| HFS-830
|
| Vol #:
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| 3
|
|
|
|
|
| 2004P-0070
|
| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
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|
|
|
|
|
|
|
|
| LET
1
|
| HFD-005 to Chesapeake Regulatory Group, Inc.
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0074
|
| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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|
|
|
|
| LET
1
|
| HFD-005 to Buchanan Ingersoll, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0088
|
| Petition to modify requirements for prescription/non prescription drug labeling
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|
|
|
|
| LET
1
|
| HFD-005 to Barbara E. Kennedy-Neslusan
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0376
|
| ANADA for a feneric intravaginal progesterone insert for cattle that differs from the pioneer product
|
|
|
|
|
| ACK
1
|
| HFA-305 to Bioniche Animal Health
USA, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Bioniche Animal Health USA, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0119
|
| Laser Light Show
|
|
|
|
|
| VRA
2
|
| HFZ-300 to CLLS Laser
|
| Vol #:
|
| 1
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|
