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| Dockets Entered
On November 6, 2003
Table of Contents
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| Docket #
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| Title
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000V-1549
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| Laser Light Show
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| 2001V-0198
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| Laser light show
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| 2002N-0417
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| Applications for FDA Approval to Market a New Drug
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003N-0338
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| Obesity
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| 2003N-0341
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| Requirements for Submission of In Vivo Bioequivalence Data
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0196
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| Switch Nicotrol Inhaler (nicotine Inhalation System) From Prescription to Over the Counter Status
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0511
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| refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
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| 2003P-0519
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| ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed
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| 2003V-0516
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| Laser Light Show
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7227
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| Jana Harker
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| Vol #:
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| 303
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| C 7228
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| Heather Harrison-Rouillard
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| Vol #:
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| 303
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| C 7229
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| Joanne Golding
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| Vol #:
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| 303
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| C 7230
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| Mr and Mrs Vito and Julie Caracci
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| Vol #:
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| 303
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| C 7231
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| Chris G. Moore
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| Vol #:
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| 303
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| C 7232
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| Lillian Buccheri
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| Vol #:
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| 303
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| C 7233
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| Jan Kemmerer
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| Vol #:
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| 303
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| C 7234
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| Robin Gaye Thrapp
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| Vol #:
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| 303
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| C 7235
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| June Chambers
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| Vol #:
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| 303
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| C 7236
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| Joan E. Button
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| Vol #:
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| 303
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| C 7237
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| Janice Emich
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| Vol #:
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| 303
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| C 7238
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| No signature
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| Vol #:
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| 303
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| C 7239
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| Eligible
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| Vol #:
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| 303
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| C 7240
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| Claudia Wondra
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| Vol #:
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| 303
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| C 7241
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| Miranda Grizio
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| Vol #:
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| 303
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| C 7242
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| Arwen Davis
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| Vol #:
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| 303
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| C 7243
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| Rebecca Abel-Kennedy
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| Vol #:
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| 303
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| C 7244
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| Bettina Bickel
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| Vol #:
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| 303
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| 2000V-1549
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| Laser Light Show
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| VRA
2
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| HFZ-300 to Bulldent Inc. dba Our Place
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| Vol #:
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| 1
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| 2001V-0198
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| Laser light show
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| VRA
2
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| HFZ-300 to Box Electronics
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| Vol #:
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| 1
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| SET
1
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| HFZ-215, GCF-1, and Patton Boggs. LLP
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| Vol #:
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| 1
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| 2002N-0417
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| Applications for FDA Approval to Market a New Drug
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| REF
1
Tab A,
continued, B
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| OMB Review 6/18/2003
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| Vol #:
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| 6
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| C
32
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| Lincare, Inc.
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| Vol #:
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| 2
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| C
33
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| Professional Assn of Diving Instructors (PADI)
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| Vol #:
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| 2
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| C
34
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| Southern Welding Supply, Inc.
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| Vol #:
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| 2
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| C
35
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| Airgas, Inc.
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| Vol #:
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| 2
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| C
36
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| Air Products Healthcare
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| Vol #:
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| 2
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| C
37
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| American Assn for Homecare (AAHomecare)
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| Vol #:
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| 2
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| C
38
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| MG Industries (MG)
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| Vol #:
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| 3
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| C
39
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| Associated Healthcare Systems, Inc.
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| Vol #:
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| 3
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| C
40
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| The MED Group
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| Vol #:
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| 3
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| C
4
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| Aventis Pasteur, Inc.
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| Vol #:
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| 1
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| C
5
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| European Federation of Pharmaceutical Industries and Associations (EFPIA)
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| Vol #:
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| 1
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| C
7
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| Pfizer, Inc.
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| Vol #:
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| 1
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| C
8
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C
9
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| Japan Society of Pharmaceutical Machinery and Engineering
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| Vol #:
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| 1
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| C
10
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| Novartis Pharmaceuticals Corp. (Novartis)
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| Vol #:
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| 1
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| C
11
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| C
12
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| C
13
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| Internationa Association for Pharmaceutical Science and Technology (PDA)
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| Vol #:
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| 1
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| C
14
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| Amgen
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| Vol #:
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| 1
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| C
15
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| Johnson-Johnson Pharmaceutical Research & Development, LLC
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| Vol #:
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| 1
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| C
10
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| Pharmaceutical BFS International Operators Assn C/o AstraZeneca R&D
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| Vol #:
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| 2
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| C
11
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| Parexel International
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| Vol #:
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| 1
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| C
12
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| Abbott Laboratories
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| Vol #:
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| 2
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| C
13
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| University of Massachusetts Medical Center
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| Vol #:
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| 2
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| C
14
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| International Association for Pharmaceutical Science and Tecnology (PDA)
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| Vol #:
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| 1
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| C
15
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| Amgen
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| Vol #:
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| 2
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| C
16
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| Bristol-Myers Squibb Pharmaceutical Research Institute
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| Vol #:
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| 2
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| C
17
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| B. Braun
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| Vol #:
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| 2
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| C
18
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| Biolog, Inc.
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| Vol #:
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| 2
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| C
19
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 2
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| C
20
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| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
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| Vol #:
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| 2
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| 2003N-0338
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| Obesity
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| LST 1
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| Agenda of October 23, 2003 Meeting
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| Vol #:
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| 3
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| TS
1
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| Video of Secretary Tommy G. Thompson's Remarks
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| Vol #:
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| 4
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| TS
2
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| Assistant Secretary for Health
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| Vol #:
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| 3
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| TS 3
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| Center for Food Safety & Applied Nutrition
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| Vol #:
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| 3
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| TS 4
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| Center for Food Safety & Applied Nutrition
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| Vol #:
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| 3
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| TS
5
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| R Craig Lefebvre, PhD
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| Vol #:
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| 3
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| TS
6
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| Girl Scouts of the USA
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| Vol #:
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| 4
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| TS 7
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| The Mount Sinai Hospital
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| Vol #:
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| 3
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| TS 8
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| ILSI North America
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| Vol #:
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| 3
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| 2003N-0341
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| Requirements for Submission of In Vivo Bioequivalence Data
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| BKG
1
Reference 1,
2, 3,
4,
5
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| Background Information
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| Vol #:
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| 2
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| C
11
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| Colorcon
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| Vol #:
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| 3
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| C
12
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| CDEX, Inc.
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| Vol #:
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| 3
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| C
13
Attachment
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| Kezzler AS
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| Vol #:
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| 3
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| C
14
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| Biocode, Inc.
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| Vol #:
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| 3
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| C
15
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 3
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| C
16
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| Cardinal Health, Inc.
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| Vol #:
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| 3
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| C
17
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| Bristol-Myers Squibb
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| Vol #:
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| 3
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| C
18
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| American Society of Health-System Pharmacists (ASHP)
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| Vol #:
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| 3
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| C
19
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| Honeywell International (Honeywell)
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| Vol #:
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| 3
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| C
20
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| Pharmaceutical Distributors Assn (PDA)
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| Vol #:
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| 3
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| C
21
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| Center for Regulatory Effectiveness (CRE)
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| Vol #:
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| 3
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| C
22
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| National Assn of Chain Drug Stores (NACDS)
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| Vol #:
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| 3
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| C
23
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| Anda, Inc.
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| Vol #:
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| 3
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| C
24
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| Thomson Healthcare, Inc.
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| Vol #:
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| 3
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| C
25
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| Smiths Detection (Smiths)
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| Vol #:
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| 3
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| C
26
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| T3C, Inc.
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| Vol #:
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| 3
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| C
27
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| Symbol Technologies, Inc.
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| Vol #:
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| 3
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| C
28
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| Pharmaceutical Printed Literature Assn (PPLA)
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| Vol #:
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| 5
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| C
29
Attachment
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| Zebra Technologies Corporation
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| Vol #:
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| 5
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| C
30
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| West Pharmaceutical Services
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| Vol #:
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| 5
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| C
31
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| Sharon Carr Associates, Ltd.
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| Vol #:
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| 5
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| C
32
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| IntelliDOT, Corp.
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| Vol #:
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| 5
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| C
33
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| US Pharmacopeia
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| Vol #:
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| 5
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| C
34
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| McKesson Corporation (McKesson)
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| Vol #:
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| 5
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| C
35
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| Amgen, Inc. (Amgen)
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| Vol #:
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| 5
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| C
36
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| American Pharmacists Assn (APhA)
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| Vol #:
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| 5
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| C
5
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| Allergy & Asthma Network
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| Vol #:
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| 1
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|
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| 2003P-0196
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| Switch Nicotrol Inhaler (nicotine Inhalation System) From Prescription to Over the Counter Status
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| |
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| LET
1
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| HFD-005 to Pharmacists Planning Services, inc.
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| Vol #:
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| 1
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| |
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 35
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| Caron Byl
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| Vol #:
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| 6
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| C 36
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| Gail C. Herath-Veiby
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| Vol #:
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| 6
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| 2003P-0511
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| refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
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| ACK
1
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| HFA-305 to Public Citizen Health Research Group
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| Vol #:
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| 1
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| CP
1
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| Public Citizen Health Research Group
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| Vol #:
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| 1
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| |
|
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| 2003P-0519
|
| ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed
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|
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| ACK
1
|
| HFA-305 to Abbott Laboratories
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| Vol #:
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| 1
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| CP
1
Exhibit
1-6, 7
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| Abbott Laboratories
|
| Vol #:
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| 1
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| 2003V-0516
|
| Laser Light Show
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| ACK 1
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| HFA-305 to Vanderbilt Museum Planetarium
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| Vol #:
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| 1
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