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| Dockets Entered
On November 5, 2003
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| |
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| 2003D-0382
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| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| |
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003M-0487
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| P020007 - Medtronic AVE Bridge Extra Support Over-the-Wire (OTW) Renal Stent System
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| 2003M-0488
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| P020041- FemCap Barrier Contraceptive
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| 2003M-0490
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| P030009 - Medtronic Vascular Driver Over-the-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems
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| 2003M-0491
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| P020050 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| 2003M-0492
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| P030008 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| 2003M-0499
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| P020047 - MULTI-LINK RX and OTW VISION Coronary Stent Systems
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0517
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| Determine that Pennifield is not now, and never has been eligible for interim marketing for bacitracin MD
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| |
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| 2003P-0518
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| Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus)
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| 2003V-0510
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| Laser Light Show
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| 2003V-0514
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| Laser Light Show
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| 2003V-0515
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| Laser Display Device
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| 2003V-0516
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| Laser Light Show
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| 1978N-0036L
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| OTC Laxative
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| C
206
Tab
1, 2,
3, 4, 5
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| Madaus AG (Madaus)
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| Vol #:
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| 121
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| LET
202
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| The Purdue Frederick Company (Purdue)
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| Vol #:
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| 121
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11465
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| Evolution-X
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| Vol #:
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| 89
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| |
|
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| LET
11466
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11467
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11468
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11469
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11470
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11471
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11472
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11473
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11474
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
|
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| LET
11475
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| Herbo, Inc.
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| Vol #:
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| 89
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|
| | | | | | | | |
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| |
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| LET
11476
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| Herbo, Inc.
|
| Vol #:
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| 89
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| |
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| LET
11477
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11478
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| Herbo, Inc.
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| Vol #:
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| 89
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| LET
11479
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11480
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11481
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| Herbo, Inc.
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| Vol #:
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| 89
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| |
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| LET
11482
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| Solgar Vitamin & Herbs
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| Vol #:
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| 89
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| |
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| LET
11483
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| Recovery Pharmaceuticals, Inc.
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| Vol #:
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| 89
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| |
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| LET
11484
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| Perrigo Company of South Carolina
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| Vol #:
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| 89
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| |
|
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| LET
11485
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| Natrol, Inc.
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| Vol #:
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| 89
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| |
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| LET
11486
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| Perrigo Company of South Carolina
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| Vol #:
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| 89
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| 2003D-0380
|
| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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|
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| EMC
2
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| Facility Automation Management
Engineering Systems
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| Vol #:
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| 1
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| |
|
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| EMC
3
Attachment
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| H. Lundbeck A/S
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| Vol #:
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| 1
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| EMC
4
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EMC
5
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| Pfizer, Inc.
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| Vol #:
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| 1
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| EMC
6
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| GlaxoSmithKline
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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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| EMC
9
Enclosure
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| European Federation of Pharmaceutical Industries and Associations (EFPIA)
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| Vol #:
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| 2
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| EMC
10
Enclosure
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| European Federation of Pharmaceutical Industries and Associations (EFPIA)
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| Vol #:
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| 2
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| |
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| EMC
11
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| Pfizer, Inc.
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| Vol #:
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| 2
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| EMC
12
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| Skan AG
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| Vol #:
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| 2
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| EMC
13
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| Robert BOSCH GmbH
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| Vol #:
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| 2
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| EMC
14
Attachment
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| Aventis Behring
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| Vol #:
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| 2
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| EMC
15
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| GlaxoSmithKline
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| Vol #:
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| 2
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| EMC
16
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| B. Braun Medical, Inc.
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| Vol #:
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| 2
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| EMC
17
Attachment
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| International Assn for Pharmaceutical Science and Technology (PDA)
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| Vol #:
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| 2
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| |
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| EMC
18
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| Parenteral Society
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| Vol #:
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| 2
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| EMC
19
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| Parenteral Society
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| Vol #:
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| 2
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| |
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| 2003D-0383
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| Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
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| |
|
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| EMC
1
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| Future Diagnostics B.V.
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| Vol #:
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| 1
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| |
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| |
|
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| EMC 9
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| Winston Wiley
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| Vol #:
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| 1
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| EMC 10
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| Sunil Shah
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| Vol #:
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| 1
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|
| | | | | | | | |
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| 2003M-0487
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| P020007 - Medtronic AVE Bridge Extra Support Over-the-Wire (OTW) Renal Stent System
|
| |
|
|
| AAV
1
Approval
order, SSED, Labelling
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| Medtronic AVE, Inc.
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| Vol #:
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| 1
|
| |
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| 2003M-0488
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| P020041- FemCap Barrier Contraceptive
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| |
|
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| AAV
1
Approval
order, SSED, Labelling
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| FemCap, Inc.
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| Vol #:
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| 1
|
| |
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| 2003M-0490
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| P030009 - Medtronic Vascular Driver Over-the-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems
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| AAV
1
Approval
order, SSED, Labelling
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| Medtornic Vascular
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| Vol #:
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| 1
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| 2003M-0491
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| P020050 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| AAV
1
Approval
order, SSED, Labelling
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| Surgi-Vision Refractive Consultants, LLC
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| Vol #:
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| 1
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| 2003M-0492
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| P030008 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| AAV
1
Approval
order, SSED, Labelling
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| Surgi-Vision Refractive Consultants, LLC
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| Vol #:
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| 1
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| |
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| 2003M-0499
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| P020047 - MULTI-LINK RX and OTW VISION Coronary Stent Systems
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| |
|
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| AAV
1
Approval
order, SSED, Labelling
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| Guidant Corporation
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| Vol #:
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| 1
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| |
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
|
| |
|
|
| EMC 8
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| M Cappuccio
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| Vol #:
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| 4
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| |
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| EMC
9
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| Academy of Managed Care Pharmacy (AMCP)
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| Vol #:
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| 4
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| |
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| EMC
10
Attachment 1,
2, 3,
4
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| Kezzler AS
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| Vol #:
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| 4
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| |
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| EMC
11
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| TSSI
|
| Vol #:
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| 4
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| |
|
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| EMC
12
Attachment 1,
2
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| Uniform Code Council, Inc. (UCC)
|
| Vol #:
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| 4
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| |
|
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| EMC
13
Attachment 1,
2
|
| Uniform Code Council, Inc. (UCC)
|
| Vol #:
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| 4
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| |
|
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| EMC
14
|
| Tracer Detection Technology Corp.
|
| Vol #:
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| 4
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| |
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| EMC 15
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| Number not Used
|
| Vol #:
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| 4
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| |
|
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| EMC
16
|
| West Pharmaceutical Services, Inc.
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| Vol #:
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| 4
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| |
|
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| EMC
17
|
| American Medical Assn (AMA)
|
| Vol #:
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| 4
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| |
|
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| EMC
18
|
| GlaxoSmithKline
|
| Vol #:
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| 4
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| |
|
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| EMC
19
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
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| 4
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| |
|
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| EMC
20
|
| National Assn of Chain Drug Stores (NACDS)
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| Vol #:
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| 4
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| |
|
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| EMC
21
|
| Amgen Inc. (Amgen)
|
| Vol #:
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| 4
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| |
|
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| EMC
22
|
| Merck & Co., Inc.
|
| Vol #:
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| 4
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| |
|
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| EMC
23
|
| Anda, Inc.
|
| Vol #:
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| 4
|
| |
|
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| EMC
24
|
| NNC Group, LLC
|
| Vol #:
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| 4
|
| |
|
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| EMC
25
Attachment 1,
2
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| Sun Microsystems, Inc. (Sun)
|
| Vol #:
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| 4
|
| |
|
|
| EMC 26
|
| Number Not Used
|
| Vol #:
|
| 4
|
| |
|
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| EMC
27
|
| American Pharmacists Assn (APhA)
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
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| |
|
| EMC
28
|
| McKesson Corporation (McKesson)
|
| Vol #:
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| 4
|
| |
|
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| EMC
29
Attachment 1,
2, 3
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| Zebra Technologies Corporation
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| Vol #:
|
| 4
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| |
|
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| EMC
30
|
| FFF Enterprises (FFF)
|
| Vol #:
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| 4
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| |
|
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| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EMC 1
|
| Thomas G. Crouthamel, Sr.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0517
|
| Determine that Pennifield is not now, and never has been eligible for interim marketing for bacitracin MD
|
| |
|
|
| ACK 1
|
| HFA-305 to Alpharma Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Tab 1,
2, 3,
4, 5,
6, 7,
8, 9,
10
|
| Alpharma Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0518
|
| Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus)
|
| |
|
|
| ACK 1
|
| HFA-305 to Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0510
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to InterVision
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0514
|
| Laser Light Show
|
|
|
| ACK 1
|
| HFA-305 to Heritage Planetarium
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Heritage Planetarium
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0515
|
| Laser Display Device
|
| |
|
|
| ACK 1
|
| HFA-305 to Full House Productions L. L. C.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Full House Productions L. L. C.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0516
|
| Laser Light Show
|
| |
|
|
| VAR
1
|
| Vanderbilt Museum Planetarium
|
| Vol #:
|
| 1
|
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