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Dockets
Management
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Dockets Entered On June 12, 2003
TABLE OF CONTENTS (Linked)
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| Docket
#
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| Title
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| 1995S-0158
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| Community Disclosure
of Institutional Review Boards
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| 1996N-0417
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| CGMP in Mfg.
Packing or Holding Dietary Supplements
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| 1999P-2547
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| Alendronate Sodium
Tablets
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| 2000P-1322
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| Food Labeling
and Allergen Contamination Control
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| 2002D-0526
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| Guidance for
drug Chemistry, Manufacturing, Control Info.
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| 2002N-0204
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| Bar Code Label
Requirements for human drug products
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| 2002P-0363
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| NDA 20-560: Fosamax
(Alendronate Sodium Tablets)
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| 2002P-0493
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| Anti-heart burn
drug Omeprazole magnesium (brand Prilosec1)
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| 2003D-0044
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| Reporting Results
for Studies Evaluating Diagnostic Tests
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| 2003N-0069
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| FDA Task Force
on Consumer Health Info for Better Nutrition
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| 2003N-0143
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| Continued Over-the-Counter
Status of Ipecac Syrup
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| 2003N-0224
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| Premarket Notification
for Food Contact Substances; Public Meeting
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| 2003P-0108
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| Permit ANADA
for Apramycin Sulfate Soluble Powder
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| CONTENTS
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| 1994P-0036
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| Req labeling
of trans fatty acid & prohibit deceptive claims
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| C 2609
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| Ray Thelen
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| Vol #:
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| 72
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| 1995S-0158
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| Community
Disclosure of Institutional Review Boards
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| RPT
11
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| University of Washington
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| Vol #:
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| 19
| Additional Material
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| 1996N-0417
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| CGMP
in Mfg. Packing or Holding Dietary Supplements
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| C 118
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| Peter M. & John
C. Family Dentistry
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| Vol #:
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| 17
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| C
119
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| K&K Laboratories,
Inc.
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| Vol #:
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| 17
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| C
120
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| Tobin Drug
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| Vol #:
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| 17
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| C
121
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| Enzymatic Therapy
Natural Medicines
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| Vol #:
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| 17
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| TR
4
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| Transcript of 4/29/2003
public Stakeholder Meeting
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| Vol #:
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| 19
| Word
Pages
1-99 pdf
Pages 100-190.
pdf
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| TR
5
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| Transcript of 5/06/2003
Public Stakeholder Meeting
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| Vol #:
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| 20
| Word
Pages
1-100.pdf
Pages 101-169.pdf
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| 1998P-0151
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| Introduction
Of Downed Cattle Into The Food Supply
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| C 6525
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| I. F. Taylor
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| Vol #:
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| 280
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| C 6526
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| Cynthia Pedersen
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| Vol #:
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| 280
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| C 6527
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| Bill Albertin
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| Vol #:
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| 280
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| C 6528
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| Gale Watts
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| Vol #:
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| 280
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|
| | | | | | | | |
| |
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| C 6529
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| Ann Campbell
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| Vol #:
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| 280
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| |
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| C 6530
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| Paul C. Szabo
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| Vol #:
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| 280
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| |
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| C 6531
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| Mr. & Mrs. Lee Spinosa
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| Vol #:
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| 280
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| |
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| C 6532
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| D. Belanger
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| Vol #:
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| 280
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| |
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| C 6533
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| no signature
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| Vol #:
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| 280
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| |
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| C 6534
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| Sylvia Berzins
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| Vol #:
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| 280
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| |
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| C 6535
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| Bernice Dobrosy
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| Vol #:
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| 280
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| |
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| C 6536
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| Mary Wicks
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| Vol #:
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| 280
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| |
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| C 6537
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| Florence Francis
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| Vol #:
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| 280
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| |
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| C 6538
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| Celia McKenzie
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| Vol #:
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| 280
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| |
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| C 6539
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| Sherill L. Stedham
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| Vol #:
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| 280
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| |
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| C 6540
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| Lucille DiBattista
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| Vol #:
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| 280
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| |
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| C 6541
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| Elaine L. Somers
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| Vol #:
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| 280
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| |
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| C 6542
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| Susana Sanchez Galtieri
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| Vol #:
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| 280
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| |
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| C 6543
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| E. Borggren
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| Vol #:
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| 280
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| |
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| C 6544
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| Beverly Matuszewski
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| Vol #:
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| 280
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| |
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| C 6545
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| Mrs. Wm. Livingston
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| Vol #:
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| 280
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| |
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| C 6546
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| Jesse Bair
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| Vol #:
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| 280
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| |
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| C 6547
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| Lorraine Stacy
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| Vol #:
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| 280
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| |
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| C 6548
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| Anne P. Taylor
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| Vol #:
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| 280
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| |
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| C 6549
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| Greta & Gerald Deutsch
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| Vol #:
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| 280
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| |
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| C 6550
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| Eileen Baldwin
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| Vol #:
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| 280
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| |
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| C 6551
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| Betty James
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| Vol #:
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| 280
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| |
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| C 6552
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| Patricia D. Woolley
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| Vol #:
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| 280
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| |
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| C 6553
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| Joann De Laine
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| Vol #:
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| 280
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| |
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| EMC 3202
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| Susan Nauslar
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| Vol #:
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| 281
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| |
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| EMC 3203
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| Janet Stoner
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| Vol #:
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| 281
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| |
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| EMC 3204
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| Karienne Gauthier
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| Vol #:
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| 281
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| |
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| EMC 3205
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| Cheryl Fisher
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| Vol #:
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| 281
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| |
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| EMC 3206
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| Melissa Maroff
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| Vol #:
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| 281
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| |
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| EMC 3207
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| Neil Edwards
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| Vol #:
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| 281
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| |
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| EMC 3208
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| Stacy & Michael Berlin
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| Vol #:
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| 281
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| |
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| EMC 3209
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| Dani Starr
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| Vol #:
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| 281
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| |
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| 1999P-2547
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| Alendronate Sodium Tablets
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| LET
2
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| HFD-1 to Merck & Co., Inc.
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| Vol #:
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| 1
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| |
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| 2000P-1322
| Food Labeling and Allergen
Contamination Control |
| | | | | | | | |
| |
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| C
531
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| The Food Allergy Network
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| Vol #:
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| 30
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| |
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| 2001P-0230
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| Domestic
Marketing & Importation of Transgenic Fish
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| C 1331
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| Rebecca D'Angelo
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| Vol #:
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| 233
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| |
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| C 1332
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| Diane Taudvin
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| Vol #:
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| 233
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| |
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| C 1333
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| Sandi Navarro
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| Vol #:
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| 233
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| |
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| C 1334
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| Harriet Gohr
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| Vol #:
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| 233
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| |
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| EMC 2723
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| Bill & Marilyn Voorhies
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| Vol #:
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| 228
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| |
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| EMC 2724
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| Crystal A. Baker
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| Vol #:
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| 228
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| EMC 2725
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| J. Farrell
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| Vol #:
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| 228
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| EMC 2726
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| Erik McMillan
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| Vol #:
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| 228
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| EMC 2727
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| Lisamarie McGrath
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| Vol #:
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| 228
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| EMC 2728
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| Andrew McGrath
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| Vol #:
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| 228
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| EMC 2729
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| Laura Southcott
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| Vol #:
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| 228
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| EMC 2730
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| Richard Smith
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| Vol #:
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| 228
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| EMC 2731
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| Nikki Sexton
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| Vol #:
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| 228
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| |
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| 2002D-0526
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| Guidance for drug Chemistry, Manufacturing, Control Info.
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| C
2
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| Harry L. Welles, PhD
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| Vol #:
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| 1
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| |
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| 2002N-0204
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| Bar Code Label Requirements for human drug products
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| C
50
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| Eli Lilly and Company
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| Vol #:
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| 14
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| |
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| C
51
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| Alpharma
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| Vol #:
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| 14
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| |
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| C
52
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| FEI Products, LLC (FEI)
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| Vol #:
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| 14
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| C
53
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| American Hospital Assn (AHA)
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| Vol #:
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| 14
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| |
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| C
54
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| Air Products Healthcare
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| Vol #:
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| 14
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| |
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| C
55
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| Greater New York Hospital Assn (GNYHA)
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| Vol #:
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| 14
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| |
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| C
56
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| Council on Radionuclides and Radiopharmaceuticals (CORAR)
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| Vol #:
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| 14
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| |
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| C
57
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| Gas Regs, Inc.
|
| Vol #:
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| 14
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| |
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| C
58
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| American Assn for Homecare (AAHomecare)
|
| Vol #:
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| 14
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| |
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| C
59
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| Thomson Healthcare, Inc.
|
| Vol #:
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| 14
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| |
|
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| C
60
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| VISI Subcommittee
|
| Vol #:
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| 14
|
| |
|
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| C
61
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| Baxter Healthcare Corporation (Baxter)
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| Vol #:
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| 14
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| |
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| C
62
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| US Pharmacopeia
|
| Vol #:
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| 14
|
| |
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| C
63
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| Plasma Protein Therapeutics Assn
|
| Vol #:
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| 14
|
| |
|
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| C
64
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| Johnson & Johnson
|
| Vol #:
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| 14
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| | | | | | | | |
| |
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| C
65
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| National Alliance for Health Information Technology (the Alliance)
|
| Vol #:
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| 14
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| |
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| C
66
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| Cardinal Health
|
| Vol #:
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| 14
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| |
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| C
67
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| DocuSys
|
| Vol #:
|
| 14
|
| |
|
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| C
68
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| Ohio State University
|
| Vol #:
|
| 14
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| |
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| C
69
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| C.B. Fleet Company, Inc.
|
| Vol #:
|
| 14
|
| |
|
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| C
70
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| Pharmaceutical Printed Literature Assn (PPLA)
|
| Vol #:
|
| 14
|
| |
|
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| C
71
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| Fresenius USA Manufacturing, Inc.
|
| Vol #:
|
| 14
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| |
|
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| C
72
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| Passport Homecare, Inc.
|
| Vol #:
|
| 14
|
| |
|
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| C
73
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
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| 14
|
| |
|
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| C
74
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| Federation of American Hospitals
|
| Vol #:
|
| 14
|
| |
|
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| C
75
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| Abbott Laboratories
|
| Vol #:
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| 14
|
| |
|
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| C
76
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| American Society of health-System Pharmacists (ASHP)
|
| Vol #:
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| 14
|
| |
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| C
77
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| Colorcon, Inc.
|
| Vol #:
|
| 14
|
| |
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| C
78
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| Hollister-Stier Laboratories, LLC (Hollister-Stier)
|
| Vol #:
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| 14
|
| |
|
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| C
79
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| Bristol-Myers Squibb
|
| Vol #:
|
| 14
|
| |
|
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| C
80
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| Generic Pharmaceutical Assn
|
| Vol #:
|
| 14
|
| |
|
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| C
81
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| AstraZeneca
|
| Vol #:
|
| 14
|
| |
|
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| C
82
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| Healthcare Leadership Council (HLC)
|
| Vol #:
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| 14
|
| |
|
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| C
83
|
| American Society of Consultant Pharmacists
|
| Vol #:
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| 14
|
| |
|
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| C
84
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| American HomePatient (AHOM)
|
| Vol #:
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| 14
|
| |
|
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| C
85
|
| West Tennessee Healthcare
|
| Vol #:
|
| 14
|
| |
|
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| C
86
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| Premier, Inc.
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| Vol #:
|
| 14
|
| |
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| EC 73
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| Schoneker, David
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| Vol #:
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| 17
|
| |
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| EC 74
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| Holmberg, Jerry
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| Vol #:
|
| 17
|
| |
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| EC 75
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| Ayres, Katharine I.
|
| Vol #:
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| 17
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| |
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| EC 76
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| Harder, Joel
|
| Vol #:
|
| 17
|
| |
|
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| EC 77
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| Harder, Joel
|
| Vol #:
|
| 17
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| |
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| EC 79
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| Tarnove, Lorraine
|
| Vol #:
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| 17
|
| |
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| EC 80
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| Shreve, Gina
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| Vol #:
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| 17
|
| |
|
|
| 2002N-0276
|
| Bioterrorism
Preparedness;Registration of Food Facilities
|
|
|
|
|
|
|
| MM 12
|
| FDA and Formatta Corporation
|
| Vol #:
|
| 13
|
| |
|
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| 2002P-0363
|
| NDA 20-560: Fosamax (Alendronate Sodium Tablets)
|
|
|
|
|
| |
|
|
| LET
2
|
| HFD-1 to Merck & Co., Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0493
|
| Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)
|
|
|
|
|
|
| | | | | | | | |
| |
|
|
| RC
1
|
| Andrx Pharmaceutical Co.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0044
|
| Reporting Results for Studies Evaluating Diagnostic Tests
|
|
|
|
|
|
|
| C
6
|
| Dade Behring, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
|
|
|
|
|
|
| C
3
|
| American Dietetic Assn (ADA)
|
| Vol #:
|
| 1
| Additional Material | |
|
|
| C
4
|
| Center for Science in he Public Interest
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0143
|
| Continued Over-the-Counter Status of Ipecac Syrup
|
|
|
|
|
|
|
| C
1
|
| Humco Holding Group, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0224
|
| Premarket Notification for Food Contact Substances; Public Meeting
|
|
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0108
|
| Permit ANADA for Apramycin Sulfate Soluble Powder
|
|
|
|
|
|
|
| PAV
1
|
| HFV-100 to Bimeda, Inc.
|
| Vol #:
|
| 1
|
|
Page Updated July 1, 2003 |
