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| Dockets Entered
On February 12, 2004
Table of Contents
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| Docket #
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| Title
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| 1980N-0050
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| Anorectal drug prod for OTC human use
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| |
|
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| 1990V-0295
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| Laser Light Show using Laser Fantasy Rainbow I
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| |
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| |
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| 2003D-0290
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| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
|
| |
|
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| |
|
|
| 2003N-0233
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
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| |
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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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| |
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
|
| |
|
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| 2003N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
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|
|
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|
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| |
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| |
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| 2003P-0505
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| ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
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| |
|
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| 2003V-0550
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| Laser Light Show
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| |
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| |
|
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| 2004P-0067
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| Revoke the regulation that approved Posilac, Monsanto's bovine growth hormone
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| |
|
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| 2004V-0005
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| Laser Light Show
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| |
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| 2004V-0007
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| Laser Light Show
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| |
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| 1980N-0050
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| Anorectal drug prod for OTC human use
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| BKG
2
Part 2,
3
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| HFD-510
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| Vol #:
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| 6
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| |
|
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| 1990V-0295
|
| Laser Light Show using Laser Fantasy Rainbow I
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| |
|
|
| VRA
6
|
| HFZ-300 to Science Center of Connecticut
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| Vol #:
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| 1
|
| |
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
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| |
|
|
| RPT
170
Notification
File
|
| Biodynamics (Distributor)
|
| Vol #:
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| 119
|
| |
|
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| RPT
171
Enclosure
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| Kups Internationl
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| Vol #:
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| 119
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| |
|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
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| LET
12652
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| PEZ International
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| Vol #:
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| 103
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| |
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| LET
12653
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| PEZ International
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| Vol #:
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| 103
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| |
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| LET
12654
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| PEZ International AG
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| Vol #:
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| 103
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| |
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| LET
12655
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| Nutrismart LLC
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| Vol #:
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| 103
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| |
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| LET
12656
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| Pharmavite LLC
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| Vol #:
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| 103
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| |
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| LET
12657
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| Pharmavite LLC
|
| Vol #:
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| 103
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|
| | | | | | | | |
| |
|
|
| LET
12658
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| Pharmavite LLC
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| Vol #:
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| 103
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| |
|
|
| LET
12659
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| Pharmavite LLC
|
| Vol #:
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| 103
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| |
|
|
| LET
12660
|
| Libentis, LLC
|
| Vol #:
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| 103
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| |
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| LET
12661
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| B & A Marketing, Inc.
|
| Vol #:
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| 103
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| |
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| LET
12662
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| Tabak's Health Products
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| Vol #:
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| 103
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| |
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| LET
12663
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| B & A Marketing Inc.
|
| Vol #:
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| 103
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| |
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| LET
12664
|
| Standard Process, Inc.
|
| Vol #:
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| 103
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| |
|
|
| LET
12665
|
| Standard Process Inc.
|
| Vol #:
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| 103
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| |
|
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| LET
12666
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| Standard Process Inc.
|
| Vol #:
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| 103
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| |
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| LET
12667
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| Standard Process Inc.
|
| Vol #:
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| 103
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| |
|
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| LET
12668
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| Standard Process Inc.
|
| Vol #:
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| 103
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| |
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| LET
12669
|
| NBYT Inc.
|
| Vol #:
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| 103
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| |
|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| EC 493
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| Taquechel, Susan
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| Vol #:
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| 163
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| |
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| EC 494
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| Hale, Cindy
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| Vol #:
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| 163
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| |
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| EC 495
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| Pauley, Adele
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| Vol #:
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| 163
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| |
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| EC 496
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| Dyson, Wendy
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| Vol #:
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| 163
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| |
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| EC 497
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| O'Brien, Marita
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| Vol #:
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| 163
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| |
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| EC 498
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| King, Edna
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| Vol #:
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| 163
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| |
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| EC 499
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| Spencer, Patrick
|
| Vol #:
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| 163
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| |
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| EC 500
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| Glorso, Rosalyn
|
| Vol #:
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| 163
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| |
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| EC 501
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| Tiernan , Peter
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| Vol #:
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| 163
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| |
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| EC 502
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| Pruet, Kelli
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| Vol #:
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| 163
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| |
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| EC 503
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| Maloy, T
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| Vol #:
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| 163
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| |
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| EC 504
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| Hampton, Ellen
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| Vol #:
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| 163
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| |
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| EC 505
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| White, Nancy
|
| Vol #:
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| 163
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| |
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| EC 506
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| Klein, Dennis
|
| Vol #:
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| 163
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| |
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| EC 507
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| Opdyke, Ellen
|
| Vol #:
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| 163
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| |
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| EC 508
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| Gaskins, R
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| Vol #:
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| 163
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| |
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| EC 509
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| hoffman, lisa
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| Vol #:
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| 163
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| |
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| EC 510
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| french, kathleen
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| Vol #:
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| 163
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| |
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| EC 511
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| Arredondo, Melissa
|
| Vol #:
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| 163
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| |
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| EC 512
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| streit, susan
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| Vol #:
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| 163
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| |
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| EC 513
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| Seibert, Diane
|
| Vol #:
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| 163
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| |
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| EC 514
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| Plummer, Beverly
|
| Vol #:
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| 163
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| |
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| EC 515
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| Sinex, Debra
|
| Vol #:
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| 163
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|
| | | | | | | | |
| |
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
| |
|
|
| C
4
|
| United States Senate
|
| Vol #:
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| 1
|
| |
|
|
| C
5
|
| Congress of the US, House of Representatives
|
| Vol #:
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| 1
|
| |
|
|
| C
6
|
| Congress of the US, House of Representatives
|
| Vol #:
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| 2
|
| |
|
|
| C
7
|
| United States Senate
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| Congress of the U S, House of Representatives
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0497
|
| Guidance for Industry on Pharmacogenomic Data Submissions
|
| |
|
|
| C
21
|
| Novartis Pharmaceuticals Corporation
|
| Vol #:
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| 2
|
| |
|
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| C
22
|
| Quintiles Transnational Corp.
|
| Vol #:
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| 2
|
| |
|
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| C
23
|
| International Society for Pharmacoepidemiology (ISPE)
|
| Vol #:
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| 2
|
| |
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
| |
|
|
| C
1
|
| Roche Diagnostics
|
| Vol #:
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| 1
|
| |
|
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| C
2
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| Community Anti-Drug Coalitions of America
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| Vol #:
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| 1
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| |
|
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| C
3
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| National Toxicology Laboratories Inc
|
| Vol #:
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| 1
|
| |
|
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| 2003D-0570
|
| Draft on the Clinical Evaluation of Weight-Control Drugs
|
| |
|
|
| EC 1
|
| Atkinson, Christine
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0233
|
| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
|
| |
|
|
| SUP
1
|
| BASF AG
|
| Vol #:
|
| 2
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C
64
|
| Indiana State Board of Animal Health
|
| Vol #:
|
| 9
|
| |
|
|
| C 65
|
| Susan Bechtholt
|
| Vol #:
|
| 9
|
| |
|
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| C 66
|
| G Seaberg
|
| Vol #:
|
| 9
|
| |
|
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| C
67
|
| Nebraska Game and Parks Commission
|
| Vol #:
|
| 9
|
| |
|
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| C
68
|
| Pet Industry Joint Advisory Council
|
| Vol #:
|
| 9
|
| |
|
|
| C 69
|
| N Cerqua
|
| Vol #:
|
| 9
|
| |
|
|
| C 70
|
| S Wills
|
| Vol #:
|
| 9
|
| |
|
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| C 71
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| B Deck
|
| Vol #:
|
| 9
|
| |
|
|
| C
72
|
| Millermeade Farms
|
| Vol #:
|
| 9
|
| |
|
|
| C
73
|
| The State of Arizona Game and Fish Department
|
| Vol #:
|
| 9
|
| |
|
|
| C
74
|
| State Board of Animal Health, ND
|
| Vol #:
|
| 9
|
| |
|
|
| C 75
|
| L Pelt
|
| Vol #:
|
| 9
|
| |
|
|
| 2003N-0468
|
| Medical Devices; Effective Date of Requirement for Premarket
|
| |
|
|
| EC 1
|
| CANADA, JAMES
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2003N-0513
|
| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
|
| |
|
|
| C
3
|
| Phoenix Regulatory Associates LTD
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0525
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
|
|
|
|
|
|
|
|
|
| C
1
|
| Juice Products Association (JPA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0529
|
| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
|
| |
|
|
| C
3
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| PhRMA, Pharmaceutical Research and Manufacturers of America
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Colgate-Palmolive Company
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 1
|
| |
|
|
| C
7
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| Plasma Protein Therapeutics Association PPTA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| C
6
|
| American Lung Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0505
|
| ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
|
| |
|
|
| AMD
1
|
| Lachman Consultant Services Inc
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFD-600 to Lachman Consultant Services
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0550
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Whatergy, Incorporated
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
| |
|
|
| RC
1
|
| Purdue Pharma LP
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0067
|
| Revoke the regulation that approved Posilac, Monsanto's bovine growth hormone
|
| |
|
|
| ACK 1
|
| HFA-305 to Robert Cohen
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Robert Cohen
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0005
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to King Laser Shows
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0007
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to East Kentucky Science Center
|
| Vol #:
|
| 1
|
|
|
|
|
