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| Dockets Entered
On July 26, 2004
Table of Contents
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| Docket #
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| Title
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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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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| 2001D-0281
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| Proposed Globally Harmonized Alternative for PMA Procedures
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| 2001D-0582
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| Available Therapy
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0254
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| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
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| 2004N-0258
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| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0269
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| Radioactive Drug Research Committees; Agency Information Collection Activities
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| 2004P-0043
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| Require Purdue Pharma to revise labeling of OxyContin Tablets
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2004P-0329
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| to consider the appropriate regulatory status for low output,hand-held doppler fetoscopes
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14094
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| Arkopharma LLC
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| Vol #:
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| 122
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| LET
14095
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| Arkopharma LLC
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| Vol #:
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| 122
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| LET
14096
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| Vitalstate, Inc.
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| Vol #:
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| 122
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| LET
14097
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| Doctor's Best, Inc.
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| Vol #:
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| 122
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| LET
14098
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| Northwest Natural Products, Inc.
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| Vol #:
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| 122
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| LET
14099
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| Naturade, Inc.
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| Vol #:
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| 122
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| LET
14100
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| Naturade, Inc.
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| Vol #:
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| 122
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| LET
14101
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| Naturade, Inc.
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| Vol #:
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| 122
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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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| C
28
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| Unilever United States, Inc. (Unilever)
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| Vol #:
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| 22
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| C
32
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| Unilever United States, Inc. (Unilever)
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| Vol #:
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| 22
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| 2001D-0281
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| Proposed Globally Harmonized Alternative for PMA Procedures
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| |
|
|
| GDL
3
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| GUIDANCE
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| Vol #:
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| 1
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| |
|
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| NAD
3
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| FDA
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| Vol #:
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| 1
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| |
|
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| 2001D-0582
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| Available Therapy
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| |
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| GDL
2
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 8356
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| K. Kammeraad
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| Vol #:
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| 283
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| |
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| EMC 8357
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| T. Terhark
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| Vol #:
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| 283
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| EMC 8358
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| E. Armm
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| Vol #:
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| 283
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| |
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| EMC 8359
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| N. Grable
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| Vol #:
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| 283
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| |
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| EMC 8360
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| M. Letendre
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| Vol #:
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| 283
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| EMC 8361
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| G. BartlettPalmer
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| Vol #:
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| 283
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| EMC 8362
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| D. Barnett
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| Vol #:
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| 283
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| EMC 8363
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| R. Hunt
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| Vol #:
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| 283
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| |
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| EMC 8364
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| N. Sauerman
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| Vol #:
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| 283
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| |
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| EMC 8365
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| G. Snedeker
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| Vol #:
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| 283
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| |
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| EMC 8366
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| J. Naughton
|
| Vol #:
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| 283
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| |
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| EMC 8367
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| B. Leonard
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| Vol #:
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| 283
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| |
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| EMC 8368
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| K. Griffin
|
| Vol #:
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| 283
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| |
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| EMC 8369
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| D. Snagerhausen
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| Vol #:
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| 283
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| EMC 8370
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| L. Marino
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| Vol #:
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| 283
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| EMC 8371
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| M. Terry
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| Vol #:
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| 283
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| EMC 8372
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| L. Kadas
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| Vol #:
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| 283
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| |
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| EMC 8373
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| P. New
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| Vol #:
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| 283
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| |
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| EMC 8374
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| H. McColgan
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| Vol #:
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| 283
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| |
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| EMC 8375
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| L. Cerdan
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| Vol #:
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| 283
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| EMC 8376
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| D. Taylor
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| Vol #:
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| 283
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| EMC 8377
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| C. Hathaway
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| Vol #:
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| 283
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| |
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| EMC 8378
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| D. Franzen
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| Vol #:
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| 283
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| |
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| EMC 8379
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| J. Strait
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| Vol #:
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| 283
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| |
|
|
| EMC 8380
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| S. Baily
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| Vol #:
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| 283
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| |
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| EMC 8381
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| P. Patchrint
|
| Vol #:
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| 283
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| |
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| EMC 8382
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| E. Barss
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| Vol #:
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| 283
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| |
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| EMC 8383
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| L. Green
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| Vol #:
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| 283
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|
| | | | | | | |
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|
| EMC 8384
|
| G. Schimmelpfennig
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| Vol #:
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| 283
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| |
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| EMC 8385
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| V. McDevitt
|
| Vol #:
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| 283
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| |
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| EMC 8386
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| K. Kelley
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| Vol #:
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| 283
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| |
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| EMC 8387
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| Susan B.
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| Vol #:
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| 283
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| |
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| EMC 8388
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| N. Young
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| Vol #:
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| 283
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| |
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| EMC 8389
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| K. Westin
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| Vol #:
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| 283
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| |
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| EMC 8390
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| P. D. Drinks
|
| Vol #:
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| 283
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| |
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| EMC 8391
|
| Unknown
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| Vol #:
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| 283
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| |
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| EMC 8392
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| E. Heller
|
| Vol #:
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| 283
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| |
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| EMC 8393
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| S. Winchester
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| Vol #:
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| 283
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| |
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| EMC 8394
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| A. A. Sanchez
|
| Vol #:
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| 283
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| |
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| EMC 8395
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| J. Tonkel
|
| Vol #:
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| 283
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| |
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| EMC 8396
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| J. C. & A. R. Colter
|
| Vol #:
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| 283
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| |
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| EMC 8397
|
| T. McDonald
|
| Vol #:
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| 283
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| |
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| EMC 8398
|
| J. Wright
|
| Vol #:
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| 283
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| |
|
|
| EMC 8399
|
| J. Williams
|
| Vol #:
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| 283
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| |
|
|
| EMC 8400
|
| H. Heunermund
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8401
|
| A. Jaffe
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8402
|
| T. Fields
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8403
|
| D. & E. Ielati
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8404
|
| M. Gardocki
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8405
|
| D. DiPietro
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8406
|
| J. A. Swem
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8407
|
| C. Sellner
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8408
|
| S. Cranston
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8409
|
| J. Yeager
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8410
|
| J. Robertson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8411
|
| D. Wagner
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8412
|
| S. Schneider
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8413
|
| T. Lark
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8414
|
| T. Eatherly
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8415
|
| S. Evans
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8416
|
| S. A. Drinks
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8417
|
| D. A. Hairgrove
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8418
|
| S. Wilson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8419
|
| M. Halibozek
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8420
|
| Y. Rice
|
| Vol #:
|
| 283
|
|
| | | | | | | |
| |
|
|
| EMC 8421
|
| E. Harris
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8422
|
| S. Millard
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8423
|
| R. Dobson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8424
|
| S. Close
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8425
|
| R. Gagnon
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8426
|
| E. Shirey
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8427
|
| S. Nelson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8428
|
| J. Heltebrake
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8429
|
| J. Evans
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8430
|
| J. Malone
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8431
|
| E. Berk
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8432
|
| C. L. Inks
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8433
|
| P. Freeman
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8434
|
| V. Hale
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8435
|
| L. O. Connor
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8436
|
| S. Jones
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8437
|
| S. Camblin
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8438
|
| L. Raddish
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8439
|
| C. Travis
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8440
|
| T. Marangello
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8441
|
| B. Werley
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8442
|
| S. Parker
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8443
|
| S. Mohler
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8444
|
| N. Hunt
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8445
|
| J. LaLande
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8446
|
| P. Grossman
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8447
|
| M. Osterloo
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8448
|
| P. LaPointe
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8449
|
| M. Kennedy
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8450
|
| A.L. Jones
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8451
|
| M. A. Mullins
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8452
|
| P. Abboud
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8453
|
| M. Cunningham
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8454
|
| E. & M. Knox
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8455
|
| J. Salihar
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8456
|
| D. Krusen
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8457
|
| E. Carey
|
| Vol #:
|
| 283
|
|
| | | | | | | |
| |
|
|
| EMC 8458
|
| E. Towler
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8459
|
| D. McGinn
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8460
|
| P. Berger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8461
|
| A. Lucero
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8462
|
| E. Ellis-Macleod
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8463
|
| C. Ahrens
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8464
|
| L. Robinson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8465
|
| G. Marshall
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8466
|
| D. Nardone
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8467
|
| S. Cole
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8468
|
| T. Gurman
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8469
|
| C. Hollenbeck
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8470
|
| W. Gallien-Hedges
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8471
|
| C. Ashford
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8472
|
| M. Pierson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8473
|
| P. Williams
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8474
|
| K. Winter
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8475
|
| A. Kennedy
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8476
|
| T. White
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8477
|
| B. Jones
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8478
|
| D. Lewis
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8479
|
| T. Jachlewski
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8480
|
| J. Crabtree
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8481
|
| T. Trella
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8482
|
| K. Jones
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8483
|
| C. Wright
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8484
|
| V. Hoskinson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8485
|
| G. Martineau
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8486
|
| S. Scheans
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8487
|
| G. Becker
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8488
|
| J. Fielder
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8489
|
| N. Fomenko
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8490
|
| J. Fomenko
|
| Vol #:
|
| 283
|
| |
|
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| EMC 8491
|
| J. Dillingham
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| Vol #:
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| 283
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| EMC 8492
|
| H. Taylor
|
| Vol #:
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| 283
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| EMC 8493
|
| G. Charpentier
|
| Vol #:
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| 283
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| EMC 8494
|
| J. Deskins
|
| Vol #:
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| 283
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| EMC 8495
|
| L. Houseman
|
| Vol #:
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| 283
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| EMC 8496
|
| V. Wolf
|
| Vol #:
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| 283
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| EMC 8497
|
| R. Lynn
|
| Vol #:
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| 283
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| EMC 8498
|
| L.W. Jolly
|
| Vol #:
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| 283
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| EMC 8499
|
| J. Weingarten
|
| Vol #:
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| 283
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|
| EMC 8500
|
| K. Sawyer
|
| Vol #:
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| 283
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| EMC 8501
|
| R. Huber
|
| Vol #:
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| 283
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|
| EMC 8502
|
| C. Lopez
|
| Vol #:
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| 283
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| EMC 8503
|
| B. Pearce
|
| Vol #:
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| 283
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|
| EMC 8504
|
| Y. Garcia
|
| Vol #:
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| 283
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|
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| EMC 8505
|
| M. Serrano
|
| Vol #:
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| 283
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| |
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| EMC 8506
|
| C. Lyons
|
| Vol #:
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| 283
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|
| EMC 8507
|
| L. Imai
|
| Vol #:
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| 283
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|
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| EMC 8508
|
| P. Moran
|
| Vol #:
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| 283
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| EMC 8509
|
| B. Emmerich
|
| Vol #:
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| 283
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| |
|
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| EMC 8510
|
| D. Murphy
|
| Vol #:
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| 283
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| |
|
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| EMC 8511
|
| K. Thomas
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8512
|
| N. Olff
|
| Vol #:
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| 283
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| |
|
|
| EMC 8513
|
| A. Jebbett
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8514
|
| I. Saftic
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8515
|
| C. Nicholas
|
| Vol #:
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| 283
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| |
|
|
| EMC 8516
|
| E. Gray-Coe
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8517
|
| S. Shaffer
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8518
|
| A. Cross
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8519
|
| K. Gollaher
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8520
|
| K. Bruss
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8521
|
| S. Nunn
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8522
|
| F. Flowing
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8523
|
| M. Burns
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8524
|
| A. Martin
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8525
|
| P. McGhee
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8526
|
| K. Harmer
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8527
|
| E. Goldstein
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8528
|
| K. Whitfield
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8529
|
| K. Hustad
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8530
|
| S. Stafford
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8531
|
| J. Chadwick
|
| Vol #:
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| 283
|
|
| | | | | | | |
| |
|
|
| EMC 8532
|
| S. Casseus
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8533
|
| R. Litchfield
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8534
|
| J. Riley
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8535
|
| P. Kennedy
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8536
|
| M. A. Castle
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8537
|
| D. Hatchett
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8538
|
| R. Weber
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8539
|
| M. Shahriar
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8540
|
| G. Miller
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8541
|
| E. Stark
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8542
|
| K. Klapper
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8543
|
| W. Brown
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8544
|
| L. Dann
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8545
|
| K. Kuldanek
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8546
|
| N. Trovato
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8547
|
| D. Devine
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8548
|
| C. Brooks
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8549
|
| K. Zimmermann
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8550
|
| G. Candelaria
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8551
|
| T. King
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8552
|
| C. Koerber
|
| Vol #:
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| 283
|
| |
|
|
| EMC 8553
|
| C. Smith
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8554
|
| K. Taylor
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8555
|
| D. Boone
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8556
|
| J. Christianson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8557
|
| S. Anderson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8558
|
| R. Roach
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8559
|
| R. Acconi
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8560
|
| A. Henderson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8561
|
| J. Wooten
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8562
|
| P. E. Gonzales
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8563
|
| C. Lininger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8564
|
| E. Singley
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8565
|
| K. Schafer
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8566
|
| S. Luallen
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8567
|
| S. Hallmark
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8568
|
| W. Maxwell
|
| Vol #:
|
| 283
|
|
| | | | | | | |
| |
|
|
| EMC 8569
|
| M. Johnston
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8570
|
| J. Bard
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8571
|
| E. Simpson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8572
|
| M. Held
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8573
|
| S. Mathews
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8574
|
| J. Gajarsa
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8575
|
| E. Acosta
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8576
|
| J. Scott
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8577
|
| S. Zachary
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8578
|
| J. McGrory
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8579
|
| J. Roberts
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8580
|
| P. Whiteman
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8581
|
| D. Ness
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8582
|
| S. White
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8583
|
| C. Fernandez-Duque
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8584
|
| D. Veselka
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8585
|
| K. Hanley
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8586
|
| J. Rogan
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8587
|
| M. Slate
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8588
|
| P. Shah
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8589
|
| C. Garger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8590
|
| L. Kruger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8591
|
| C. Holland
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8592
|
| M. Shockley
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8593
|
| M. Russell
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8594
|
| M. Ellington
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8595
|
| C. Tirrell
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8596
|
| M. Sinnotte
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8597
|
| J. Werness
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8598
|
| K. Seeger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8599
|
| H. Stackhouse
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8600
|
| K. Porter
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8601
|
| E. Harkins
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8602
|
| J. Morris
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8603
|
| A. Stanaford
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8604
|
| J. Chizever
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8605
|
| K. McRoberts
|
| Vol #:
|
| 283
|
|
| | | | | | | |
| |
|
|
| EMC 8606
|
| N. Mauro
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8607
|
| G. Artl
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8608
|
| N. Hufford
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8609
|
| B. Logan
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8610
|
| E. Howell
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8611
|
| H. Gilbert
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8612
|
| H. Lilla
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8613
|
| S. Borges
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8614
|
| D. Ruse
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8615
|
| L. DaCosta
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8616
|
| A. Blockinger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8617
|
| M. Palmer
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8618
|
| A. Allen
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8619
|
| W. Riser
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8620
|
| M. Miller
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8621
|
| J. Miller
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8622
|
| M. Pack
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8623
|
| S. Elliman
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8624
|
| E. Blockinger
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8625
|
| G. Garrett
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8626
|
| C. Whitney
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8627
|
| C. Byrne
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8628
|
| F. Bygate
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8629
|
| E. Miller
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8630
|
| J. Van Kolken
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8631
|
| M. Cusick
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8632
|
| J. Vance
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8633
|
| M. Boswell
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8634
|
| S. Fields
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8635
|
| J. Child
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8636
|
| L. Nealer
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8637
|
| A. Eck
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8638
|
| S. Rondou
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8639
|
| K. Davis
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8640
|
| A. Blum
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8641
|
| K. Hurst
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8642
|
| A. Scott
|
| Vol #:
|
| 283
|
|
| | | | | | | | |
| |
|
|
| EMC 8643
|
| G. Beach
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8644
|
| S. Desai
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8645
|
| C. Murphy
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8646
|
| K. Scholl
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8647
|
| N. Nikisch
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8648
|
| T. El-Saadiq
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8649
|
| J. Falzerano
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8650
|
| C. Hendrickson
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8651
|
| J. Flemmons
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8652
|
| N. T. Keyser
|
| Vol #:
|
| 283
|
| |
|
|
| EMC 8653
|
| C. Harrington
|
| Vol #:
|
| 283
|
| |
|
|
| 2003N-0342
|
| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
|
| |
|
|
| C
1
|
| Wyeth Consumer Healthcare (Wyeth)
|
| Vol #:
|
| 2
|
| |
|
|
| C
2
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 2
|
| |
|
|
| C
3
|
| Honorable Bart Stupak
|
| Vol #:
|
| 2
|
| |
|
|
| C
4
|
| Pharmaceutical Printed Literature Assn (PPLA)
|
| Vol #:
|
| 2
|
| |
|
|
| C
5
|
| Pfizer Consumer Healthcare (Pfizer)
|
| Vol #:
|
| 2
|
| |
|
|
| C
6
|
| Cosmetic, Toiletry and Fragrance Assn (CTFA)
|
| Vol #:
|
| 2
|
| |
|
|
| C
7
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| C 21
|
| P. Johnson
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
| |
|
|
| ACK
2
|
| Abbott Laboratories
|
| Vol #:
|
| 4
|
| |
|
|
| PRC
1
Tabs
A-D, E
|
| Abbott Laboratories
|
| Vol #:
|
| 4
|
| |
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
| |
|
|
| ACK 2
|
| HFA-305 to Abbott Laboratories
|
| Vol #:
|
| 5
|
| |
|
|
| PRC
1
Tabs
A-D, E
|
| Abbott Laboratories
|
| Vol #:
|
| 5
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| C 22
|
| D. Ryan
|
| Vol #:
|
| 2
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| C
35
|
| Becton, Dickinson and Company
(BD)
|
| Vol #:
|
| 6
|
| |
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
| | | | | | | | |
| |
|
|
| C
4
|
| Ernst & Young, LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0254
|
| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
|
| |
|
|
| C
1
|
| Indiana University
|
| Vol #:
|
| 1
|
| |
|
|
| C 2
|
| M. Tynan,MD,FRCP
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Management Advisory Services
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| American Academy of Pediatric Dentistry
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
| |
|
|
| C
2
|
| International Fresh-cut Produce Assn (IFPA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
| |
|
|
| C 1
|
| D and P Brandt
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
3
|
| Moyer Packing Company (MOPAC)
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
4
|
| Boer Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
5
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
6
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
7
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
8
Attachment
|
| Tallowmasters, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
9
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
10
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EXT
11
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0269
|
| Radioactive Drug Research Committees; Agency Information Collection Activities
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0043
|
| Require Purdue Pharma to revise labeling of OxyContin Tablets
|
|
|
| LET
2
|
| HFD-005 to State of Connecticut
|
| Vol #:
|
| 3
|
| |
|
|
| 2004P-0113
|
| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
|
| |
|
|
| C
2
Continued
|
| AstraZeneca Pharmaceuticals, LP
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
|
| |
|
|
| SUP
3
|
| King Pharmaceuticals, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| 2004P-0329
|
| to consider the appropriate regulatory status for low output,hand-held doppler fetoscopes
|
| |
|
|
| ACK 1
|
| HFA-305 to Russel J. Thomsen, M.D.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Russel J. Thomsen, M.D.
|
| Vol #:
|
| 1
|
|
|
