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| Dockets
Entered On August 29, 2003
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| Docket #
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| Title
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| 1980N-0050
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| Anorectal drug prod for OTC human
use
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| 1998P-0169
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| Labeling Standards for Botanicals,
Homeopathics, etc.
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| 2002N-0434
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| Withdrawal of Certain Proposed
rules & other propose action
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| 2002N-0475
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| Financial Relationships &
Interest in Research Involving Hum
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| 2003D-0120
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| Multiplex Tests for Heritable
DNA Markers, Mutations & Expre
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| 2003D-0165
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| Current Good Manufacturing Practices
for Medical Gases
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| 2003D-0226
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| Draft Guidance for Industry and
FDA Staff; Compliance with Section 301 of the Medical Device User Fee
and Modernization Act of 2002; Identification of Manufacturer of Medical
Devices; Availability
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| 2003N-0346
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| Food Labeling: Ingredient Labeling
of Dietary Supplements That Contain Botanicals
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003P-0082
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| Abbreviated New Drug Application
(ANDA) for Ursodiol Oral
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| 2003P-0110
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| ANDA Suitability for Epirubicin
Hydrochloride Injection
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| 2003P-0297
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| Exemption from 510(k) process
for an Accessory to Electrode Cable
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| 2003P-0398
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| (ANDA) for Oral Capsule Dosage
Form Containing Hydrocodone Bitartrate 5 mg/Butalbital 50 mmg/ Cafferine
40mg/ Acetaminophen 325mg
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| 2003V-0394
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| Laser Light Show
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| 2003V-0395
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| Laser Light Show
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| 2003V-0396
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| Laser Light Show
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| 1980N-0050
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| Anorectal drug prod
for OTC human use
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| NFR
4
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| FDA
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| Vol #:
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| 2
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| 1998P-0151
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| Introduction Of Downed Cattle
Into The Food Supply
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| | | | | | | |
| |
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| C 6977
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| Mr. Kameron O'Daniel
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| Vol #:
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| 296
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| |
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| C 6978
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| Marjorie Nelson
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| Vol #:
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| 296
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| |
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| EMC 3570
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| Rona Kwestel
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| Vol #:
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| 295
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| |
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| EMC 3571
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| M. Nedopak
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| Vol #:
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| 295
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| |
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| EMC 3572
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| LAKOGREEN
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| Vol #:
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| 295
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| |
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| EMC 3573
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| Pegslaven
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| Vol #:
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| 295
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| |
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| EMC 3574
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| LAKOGREEN
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| Vol #:
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| 295
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| |
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| EMC 3575
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| LAKOGREEN
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| Vol #:
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| 295
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| |
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| EMC 3576
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| LAKOGREEN
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| Vol #:
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| 295
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| |
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| EMC 3577
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| Tezel Relyea
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| Vol #:
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| 295
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| |
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| EMC 3578
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| Jeri Lutman
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| Vol #:
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| 295
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| |
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| EMC 3579
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| number not used
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| Vol #:
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| 295
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| |
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| EMC 3580
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| Mrs. Tezel Relyea
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| Vol #:
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| 295
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| |
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| EMC 3581
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| Charles Murrow
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| Vol #:
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| 295
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| |
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| EMC 3582
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| James Love
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| Vol #:
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| 295
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| |
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| EMC 3583
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| Leslie Brown
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| Vol #:
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| 295
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| |
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| EMC 3584
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| Renee
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| Vol #:
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| 295
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| |
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| EMC 3585
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| Debby Resnick
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| Vol #:
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| 295
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| |
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| EMC 3586
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| Ken Cole
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| Vol #:
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| 295
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| |
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| EMC 3587
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| William & Kathryn LaPlante
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| Vol #:
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| 295
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| |
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| EMC 3588
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| Judith Overby
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| Vol #:
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| 295
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| |
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| EMC 3589
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| Dorothy R. Heitjan
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| Vol #:
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| 295
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| |
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| EMC 3590
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| Taylor Anderson
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| Vol #:
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| 295
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| |
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| EMC 3591
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| Robin Mills
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| Vol #:
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| 295
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| |
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| EMC 3592
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| Brad Bergeron
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| Vol #:
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| 295
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| |
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| EMC 3593
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| Alice Bartholmew
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| Vol #:
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| 295
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| |
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| EMC 3594
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| Patti Ragan
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| Vol #:
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| 295
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| |
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| EMC 3595
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| Judith Newby
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| Vol #:
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| 295
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| |
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| EMC 3596
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| Dawn M. Authier
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| Vol #:
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| 295
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| |
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| EMC 3597
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| Cindy McDaniel
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| Vol #:
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| 295
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| |
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| EMC 3598
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| Tanya McCarthy
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| Vol #:
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| 295
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| |
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| EMC 3599
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| Diane
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| Vol #:
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| 295
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| |
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| EMC 3600
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| Gerhild N. Paris
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| Vol #:
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| 295
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| |
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| EMC 3601
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| April Thompson
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| Vol #:
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| 295
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| |
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| EMC 3602
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| A. Thompson
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| Vol #:
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| 295
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| |
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| EMC 3603
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| Lisa K. Ayers
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| Vol #:
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| 295
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| |
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| EMC 3604
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| Gerhild Paris
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| Vol #:
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| 295
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| EMC 3605
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| Charisma Nevel
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| Vol #:
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| 295
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| EMC 3606
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| Darlene Robinette
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| Vol #:
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| 295
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| EMC 3607
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| Spikelangel
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| Vol #:
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| 295
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| EMC 3608
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| Jayaweera
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| Vol #:
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| 295
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| EMC 3609
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| L. Sherwood
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| Vol #:
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| 295
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| 1998P-0169
|
| Labeling Standards for
Botanicals, Homeopathics, etc.
|
|
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|
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| SUP
2
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| Pharmacists Planning Service,
Inc (PPSI)
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| Vol #:
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| 1
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| 2001P-0230
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| Domestic Marketing &
Importation of Transgenic Fish
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| EMC 3040
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| Jesse Young
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| Vol #:
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| 252
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| EMC 3041
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| Alison Hriciga
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| Vol #:
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| 252
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| EMC 3042
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| Raymond Wager
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| Vol #:
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| 252
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| EMC 3043
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| Demelza Costa
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| Vol #:
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| 252
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| EMC 3044
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| Teresa Prado
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| Vol #:
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| 252
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| EMC 3045
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| Betty J. Van Wicklen
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| Vol #:
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| 252
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| 2002N-0434
|
| Withdrawal of Certain
Proposed rules & other propose action
|
|
|
|
|
|
|
| C
29
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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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| 2002N-0475
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| Financial Relationships
& Interest in Research Involving Hum
|
|
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|
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|
|
| EMC
10
|
| National Science Foundation
|
| Vol #:
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| 2
|
|
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| 2003D-0120
|
| Multiplex Tests for
Heritable DNA Markers, Mutations & Expre
|
|
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|
|
|
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|
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| EMC
5
|
| American Clinical Laboratory
Association
|
| Vol #:
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| 2
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|
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| 2003D-0165
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| Current Good Manufacturing
Practices for Medical Gases
|
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|
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| C
7
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| Complient
|
| Vol #:
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| 1
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| NEC
1
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| FDA
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| Vol #:
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| 1
|
|
|
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|
| 2003D-0226
|
| Draft Guidance for Industry and
FDA Staff; Compliance with Section 301 of the Medical Device User Fee
and Modernization Act of 2002 b Identification of Manufacturer of Medical
Devices; Availability
|
|
|
|
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| C
1
|
| Phillips Medical Systems
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| Vol #:
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| 1
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| 2003N-0344
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| Consumer-Directed Promotion;
Public Meeting
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| APE 5
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| Coshar Medica Inc.
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| Vol #:
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| 1
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| APE 6
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| Time Inc.
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| Vol #:
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| 5
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| APE 7
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| Janet Hoek (New Zealand)
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| Vol #:
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| 1
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| APE 8
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| Pfizer Inc
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| Vol #:
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| 1
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| APE 9
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| Catalina Health Resource
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| Vol #:
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| 1
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| APE 10
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| Zynx Health Incorporated
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| Vol #:
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| 1
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| APE 11
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| American Enterprise Institute
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| Vol #:
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| 1
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| APE 12
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| University of Minnesota
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| Vol #:
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| 1
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| APE 13
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| Rodale Inc
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| Vol #:
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| 1
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| APE 14
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| Massachusetts General Hospital
Institute for Health Policy
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| Vol #:
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| 1
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| APE 15
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| National Consumers League
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| Vol #:
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| 1
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| APE 16
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| William J Vigilante Jr PhD
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| Vol #:
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| 1
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| APE 17
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| Columbia University
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| Vol #:
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| 1
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| APE 18
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| Harvard Medical School
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| Vol #:
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| 1
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| APE 19
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| University of Michigan
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| Vol #:
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| 1
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| APE 20
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| University of Texas
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| Vol #:
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| 1
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| APE 21
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| University of California,
Davis
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| Vol #:
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| 1
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| APE 22
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| Harris Interactive
|
| Vol #:
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| 1
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| APE 23
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| Parade Magazine
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| Vol #:
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| 1
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|
|
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| 2003N-0346
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| Food Labeling:
Ingredient Labeling of Dietary Supplements That Contain Botanicals
|
|
|
|
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
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| 2003N-0361
|
| Anti-Counterfeit
Drug Initiative
|
|
|
|
|
|
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| N
1
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| FDA
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| Vol #:
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| 1
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|
|
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| 2003P-0082
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| Abbreviated
New Drug Application (ANDA) for Ursodiol Oral
|
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|
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|
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| PAV
1
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| HFD-600 to Lachman Consultant
Services, Inc
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| Vol #:
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| 1
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|
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| 2003P-0110
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| ANDA Suitability
for Epirubicin Hydrochloride Injection
|
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|
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|
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| PAV
1
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| HFD-600 to Faulding Pharmaceutical
Company
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| Vol #:
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| 1
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| 2003P-0297
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| Exemption
from 510(k) process for an Accessory to Electrode Cable
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| WDL
1
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| Peter M Rothenberg, MD MA
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| Vol #:
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| 1
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| 2003P-0393
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| Diazepam
Injection USP, 5 mg/mL, 1-mL,(ANDA No. 72-079), by Abbott laboratories,
Inc., has been voluntarily withdrawn or withheld from sale for safety
or efficacy reasons
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| ACK 2
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| HFA-305 to PharmaForce, Inc.
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| Vol #:
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| 1
|
|
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|
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| 2003P-0398
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| (ANDA) for
Oral Capsule Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital
50 mmg/ Cafferine 40mg/ Acetaminophen 325mg
|
|
|
|
|
|
| | | | | | | | |
| |
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| ACK
1
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| HFA-305 to International Regulatory Business Consultants, LLC
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| Vol #:
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| 1
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| |
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| CP
1
Attachment 1, 2, 3, 4, 5, 6 |
| International Regulatory Business Consultants, LLC
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| Vol #:
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| 1
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| |
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| 2003V-0389
|
| Laser Display Device
|
|
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| |
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| ACK 2
|
| NUMBER NOT USED
|
| Vol #:
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| 1
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| |
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| 2003V-0394
|
| Laser Light Show
|
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|
|
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| ACK
1
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| HFA-305 to XO
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| Vol #:
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| 1
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| |
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| 2003V-0395
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| Laser Light Show
|
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| ACK
1
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| HFA-305 to Lunar Bowl
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| Vol #:
|
| 1
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| |
|
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| VAR
1
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| Lunar Bowl
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| Vol #:
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| 1
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| |
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| 2003V-0396
|
| Laser Light Show
|
|
|
|
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|
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| ACK
1
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| HFA-305 to Kaanapali Beach Hotel
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| Vol #:
|
| 1
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| |
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| VAR
1
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| Kaanapali Beach Hotel
|
| Vol #:
|
| 1
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|
