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| Dockets Entered
On October 13, 2004
Table of Contents
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| Docket #
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| Title
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| 1994V-0306
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| Laser Light Show
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999V-1390
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| Laser Light Show & Projector for Laser Light Show
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0510
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| Proposal to Debar Thomas M. Rodgers, Jr.
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| 2002P-0444
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| cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004N-0408
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| Regulatory Site Visit Training Program
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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-0129
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| Modify Current Regulation Governing Structure/function Claims, 21 CFR Pt. 101.93
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| 2004P-0131
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| ANDA Suitability for Tofin (tobramycin for Inhalation)
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| 2004P-0169
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| Erroneous Interpretation of the Statutory Definition of the Term "Dietary Supplement"
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0372
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| ANADA suitability for generic carprofen chewable tablet
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| 2004P-0429
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| Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| 1994V-0306
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| Laser Light Show
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| VRA
5
Attachment A,
B
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| HFZ-300 to West Coast Lser Service
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| Vol #:
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| 1
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| LET
49
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| Chinese Herbal Products Committee of AHPA
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| Vol #:
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| 398
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
779
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| HFS-800 to Dragon Herbs
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| Vol #:
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| 24
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| LET
780
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| HFS-800 to EuroPharma, Inc.
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| Vol #:
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| 24
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| LET
781
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| HFS-800 to Sedona Laboratories, Inc
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| Vol #:
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| 24
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| LET
782
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| HFS-800 to Anabolic Laboratoreis, Inc
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| Vol #:
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| 24
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| LET
783
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| HFS-800 to Vita Pharmica
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| Vol #:
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| 24
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| LET
784
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| HFS-800 to Yu Shen Tang Chinese Herbal Medicine LLC
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| Vol #:
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| 24
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| LET
785
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| HFS-800 to ZEO Health Ltd.
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| Vol #:
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| 24
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 557
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| D. Fiddler
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| Vol #:
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| 24
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 797
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| K. Bresson
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| Vol #:
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| 33
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| EMC 798
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| L. Hughes
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| Vol #:
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| 33
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| 1999V-1390
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| Laser Light Show & Projector for Laser Light Show
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| VRA
2
Attachment A,
B
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| HFZ-300 to Pangolin Laser Systems, Inc.
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| Vol #:
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| 1
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 642
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 643
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 644
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| Center for Veterinary Medicine
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| Vol #:
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| 439
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| EXB 645
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| Center for Veterinary Medicine
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| Vol #:
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| 440
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| EXB 646
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| Center for Veterinary Medicine
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| Vol #:
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| 340
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| EXB 647
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| Center for Veterinary Medicine
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| Vol #:
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| 441
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| EXB 648
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| Center for Veterinary Medicine
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| Vol #:
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| 442
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| EXB 649
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| Center for Veterinary Medicine
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| Vol #:
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| 442
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| EXB 650
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| Center for Veterinary Medicine
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| Vol #:
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| 442
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| EXB 651
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| Center for Veterinary Medicine
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| Vol #:
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| 442
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| EXB 652
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| Center for Veterinary Medicine
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| Vol #:
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| 442
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 10570
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| E. Edenfield
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| Vol #:
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| 294
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| EMC 10571
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| A. Mazeppa
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| Vol #:
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| 294
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| EMC 10572
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| B. Jalowiec
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| Vol #:
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| 294
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| EMC 10573
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| B. Olson
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| Vol #:
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| 294
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| EMC 10574
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| M. Waddill
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| Vol #:
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| 294
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| EMC 10575
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| K. Jalowiec
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| Vol #:
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| 294
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| EMC 10576
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| K. Jalowiec
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| Vol #:
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| 294
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| EMC 10577
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| G. Gilliam
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| Vol #:
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| 294
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| EMC 10578
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| G. Gilliam
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| Vol #:
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| 294
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| EMC 10579
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| J. Ruscella
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| Vol #:
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| 294
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| | | | | | | | |
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| EMC 10580
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| O. Gudz
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| Vol #:
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| 294
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| EMC 10581
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| A. Shaffer
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| Vol #:
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| 294
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| EMC 10582
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| D. Nall
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| Vol #:
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| 294
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| EMC 10583
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| A. Avila
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| Vol #:
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| 294
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| EMC 10584
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| M. Madrigal
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| Vol #:
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| 294
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| EMC 10585
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| M. Lowe
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| Vol #:
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| 294
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| EMC 10586
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| M. Perez
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| Vol #:
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| 294
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| EMC 10587
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| J. Cohen
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| Vol #:
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| 294
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| EMC 10588
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| R. Neal
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| Vol #:
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| 294
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| EMC 10589
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| T. Strauss
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| Vol #:
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| 294
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| EMC 10590
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| L. Wells
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| Vol #:
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| 294
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| EMC 10591
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| S. Brock
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| Vol #:
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| 294
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| EMC 10592
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| K. Johnson
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| Vol #:
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| 294
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| EMC 10593
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| S. Kershner
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| Vol #:
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| 294
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| 2002N-0510
|
| Proposal to Debar Thomas M. Rodgers, Jr.
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|
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|
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| M
1
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| GCF-1 to Staff Attorneys and DDM
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| Vol #:
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| 1
|
|
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| 2002P-0444
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| cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg
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| LET
2
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| HFD-600 to The Weinberg Group, Inc.
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| Vol #:
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| 1
|
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 417
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| A. Christoff
|
| Vol #:
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| 9
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| EMC 418
|
| D. Snover
|
| Vol #:
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| 9
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| |
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| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
|
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|
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| EXT
1
|
| American Assn for Homecare (AAHomecare)
|
| Vol #:
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| 1
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| EXT
2
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| Air Products Healthcare
|
| Vol #:
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| 1
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|
|
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| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| C 101
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| M. Florentino
|
| Vol #:
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| 12
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|
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| C 102
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| K. Wells
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| Vol #:
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| 12
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| C 103
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| T. Ponder
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| Vol #:
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| 12
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| C 104
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| C. Kilborn
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| Vol #:
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| 12
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| C 105
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| S. Dennison
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| Vol #:
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| 12
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| C 106
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| C. Giffin
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| Vol #:
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| 12
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| C 107
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| M and G Warholak
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| Vol #:
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| 12
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| C 108
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| M. Waidler
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| Vol #:
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| 12
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| C 109
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| H and G Mroz
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| Vol #:
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| 12
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| | | | | | | | |
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| |
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| EMC 1039
|
| P. Stapleton
|
| Vol #:
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| 11
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| EMC 1040
|
| E. Friedman
|
| Vol #:
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| 11
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| EMC 1041
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| S. Taylor
|
| Vol #:
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| 11
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|
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| EMC 1042
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| G. Beatty
|
| Vol #:
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| 11
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| EMC 1043
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| E. Baiano
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| Vol #:
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| 11
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| EMC 1044
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| J. Grout
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| Vol #:
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| 11
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| EMC 1045
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| M. Max
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| Vol #:
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| 11
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| EMC 1046
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| S. Nation
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| Vol #:
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| 11
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| EMC 1047
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| J. Mejuto
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| Vol #:
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| 11
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| EMC 1048
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| C. Kerr
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| Vol #:
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| 11
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| EMC 1049
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| S. Polon
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| Vol #:
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| 11
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| EMC 1050
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| I. Gedo
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| Vol #:
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| 11
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| EMC 1051
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| A. Hoffman
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| Vol #:
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| 11
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| EMC 1052
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| B. Monaghan
|
| Vol #:
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| 11
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| EMC 1053
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| R. Benedict
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| Vol #:
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| 11
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| EMC 1054
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| Dr.. and Mrs. D Sloan
|
| Vol #:
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| 11
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|
|
|
|
| 2004N-0257
|
| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
|
|
|
|
|
| EMC
19
Attachment
|
| Croda Chemicals Europe, Ltd
|
| Vol #:
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| 3
|
|
|
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
|
|
|
|
| LET
1
|
| LifeSouth Community Blood Centers, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
|
|
| PDN
2
|
| HF-22 to Emord & Associates, PC on behalf of Weider Nutritoin International Inc
|
| Vol #:
|
| 17
|
|
|
|
|
| 2004P-0060
|
| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
|
|
|
|
|
| PDN
1
|
| HF-22 to Hogan & Hartson LLP on behalf of Rotta Pharmaceuticals, Inc
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004P-0129
|
| Modify Current Regulation Governing Structure/function Claims, 21 CFR Pt. 101.93
|
|
|
|
|
| LET
1
|
| HFS-800 to Emord & Associates, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0131
|
| ANDA Suitability for Tofin (tobramycin for Inhalation)
|
|
|
|
|
| C
3
|
| Corus Pharma, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0169
|
| Erroneous Interpretation of the Statutory Definition of the Term "Dietary Supplement"
|
|
|
|
|
| LET
1
|
| HFS-800 to Coalition To Preserve DSHEA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
|
|
|
| LET
1
|
| HFD-005 to Genentech, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2004P-0324
|
| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
|
|
|
|
|
| C
1
|
| Olsson, Frank and Weeda, P.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| C
3
|
| National Autism Assn (NAA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0372
|
| ANADA suitability for generic carprofen chewable tablet
|
|
|
|
|
| PAV
1
|
| HFV-100 to Intervet Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0429
|
| Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
|
|
|
|
|
| C
1
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0457
|
| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
|
|
|
|
|
| ACK
1
|
| HFA-305 to Endotec, Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| CCP
1
|
| Endotec, Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| HFZ-400 to Endotec, Incorporated
|
| Vol #:
|
| 2
|
|
