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| Dockets Entered
On June 29, 2004
Table of Contents
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| Docket
#
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| Title
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| 1976N-0080
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| LABELING FOR DIGOXIN
PRODUCTS
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| 1994P-0268
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| Essential Use Exemption
for Implantable Infusion Pump
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| 1997N-0484S
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| Human Cellular and
Tissue-Based Products
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| 1998P-0151
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| Introduction Of Downed
Cattle Into The Food Supply
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2000N-1610
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| Digoxin Products Oral
Use;Revocation conditions marketing
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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| 2002P-0406
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| ANDA Suitability for
Amoxicillin & Clavulanate Potassium
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| 2003D-0206
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| Draft Guidance for
Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
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| 2003D-0554
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| Compliance Policy
Guide Sec. 110.310 Prior Notice of Imported Food Under the Public
Health Security and Bioterrorism Preparedness and Response Act of
2002
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|
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|
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| 2003D-0562
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| Compliance Policy
Guide Sec.110.300 Registration of Food Facilities Under the Public
Health Security and Bioterrorism Preparedness and Response Act of
2002
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids
in Nutrition Labeling; Consumer research to consider possible footnote
statements
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| 2003P-0029
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| Remove metered-dose inhalers
(MDI) containing moiety albuter
|
|
|
| 2003P-0126
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| Refrain from approving
(ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
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| 2003P-0387
|
| Request that the Commissioner
of Food and Drug take action described methodology for oral levothyroxine
sodium drug products
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|
|
| 2004D-0082
|
| Guidance for Industry and FDA
Staff: Class II Special Controls Guidance Document: Factor V Leiden
DNA Mutation Detection Systems; Availability
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| 2004N-0166
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Infant Feeding Practices
Study II
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| 2004N-0176
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| Preparation for the
International Conference on Harmonization Meetings in Washington,
DC: Public Meeting
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| 2004N-0181
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| Critical Path Initiative
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|
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| 2004P-0261
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| Prevent Pfizer Inc. from marketing
a generic version of Accupril until after the expiration of Teva's
180-day exclusivity period
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|
| 2004Q-0180
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| Qualified Health Claim
(QHC): Lutein and Eye Diseases
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| 2004S-0170
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| Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Section 1013: Suggest
Priority Topics for Research
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| 2004V-0274
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| Projector for a Laser
Light Show
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| 1976N-0080
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| LABELING FOR DIGOXIN
PRODUCTS
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| N
1
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| FDA
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| Vol #:
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| 6
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| 1994P-0268
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| Essential Use Exemption
for Implantable Infusion Pump
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| SUP
1
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| Medtronic MiniMed
(MiniMed)
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| Vol #:
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| 1
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| 1997N-0484S
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| Human Cellular
and Tissue-Based Products
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| REF
2
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| OMB Review for May
25, 2004
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| Vol #:
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| 45
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| LET
753
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| HFS-800 to Patent
HEALTH LLC
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| Vol #:
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| 23
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| LET
754
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| HFS-800 to Biotech
Corporation Inc
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| Vol #:
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| 23
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| LET
755
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| HFS-800 to HerbsForever,
Inc
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| Vol #:
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| 23
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| LET
756
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| HFS-800 to Aska Corporation
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| Vol #:
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| 23
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| LET
757
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| HFS-800 to Chemron
Inc
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| Vol #:
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| 23
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| LET
758
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| HFS-800 to Integrative
Therapeutics, Inc
|
| Vol #:
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| 23
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| LET
759
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| HFS-800 to Arkopharma
LLC
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| Vol #:
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| 23
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| 1998P-0151
|
| Introduction Of
Downed Cattle Into The Food Supply
|
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| C 7438
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| R. Carpenter
|
| Vol #:
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| 307
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| | | | | | | | |
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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|
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| EXB 165
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| Center for Veterinary Medicine
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| Vol #:
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| 415
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| EXB 166
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| Center for Veterinary Medicine
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| Vol #:
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| 415
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| EXB 167
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| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 168
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| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 169
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| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 170
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| Center for Veterinary Medicine
|
| Vol #:
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| 415
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|
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| EXB 171
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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|
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| EXB 172
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 173
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 174
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 175
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| Center for Veterinary Medicine
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| Vol #:
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| 415
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| EXB 176
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 177
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 178
|
| Center for Veterinary Medicine
|
| Vol #:
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| 415
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| EXB 179
|
| Center for Veterinary Medicine
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| Vol #:
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| 415
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| EXB 180
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| Center for Veterinary Medicine
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| Vol #:
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| 415
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|
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|
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| 2000N-1610
|
| Digoxin Products Oral Use;Revocation conditions marketing
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
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|
|
| EC 803
|
| Mr. Mike Beaty
|
| Vol #:
|
| 163
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|
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| EC 805
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| Dr. Joan Sage
|
| Vol #:
|
| 163
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| EMC 7463
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| L. Castello
|
| Vol #:
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| 280
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| EMC 7464
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| B. S. Miller
|
| Vol #:
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| 280
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|
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| EMC 7465
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| A. Sattler
|
| Vol #:
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| 280
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|
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| EMC 7466
|
| K. E. Kennedy
|
| Vol #:
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| 280
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|
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| EMC 7467
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| T. Karl
|
| Vol #:
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| 280
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| EMC 7468
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| M. Turner
|
| Vol #:
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| 280
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| EMC 7469
|
| A. Hallet
|
| Vol #:
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| 280
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| EMC 7470
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| J. Kendall
|
| Vol #:
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| 280
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| EMC 7471
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| J. Stevens
|
| Vol #:
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| 280
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|
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| EMC 7472
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| J. Steiner
|
| Vol #:
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| 280
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| EMC 7473
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| R. E. Brown
|
| Vol #:
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| 280
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| EMC 7474
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| L. Lucas
|
| Vol #:
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| 280
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| EMC 7475
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| A. P. Cawley
|
| Vol #:
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| 280
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| EMC 7476
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| P. Marietta
|
| Vol #:
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| 280
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| EMC 7477
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| G. Summer Scabough
|
| Vol #:
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| 280
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| EMC 7478
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| K. J. Garner
|
| Vol #:
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| 280
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| EMC 7479
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| K. Larkin
|
| Vol #:
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| 280
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| EMC 7480
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| C. Wielgus
|
| Vol #:
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| 280
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| EMC 7481
|
| M. Bedard
|
| Vol #:
|
| 280
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|
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| EMC 7482
|
| A. Ashmore
|
| Vol #:
|
| 280
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| EMC 7483
|
| A. Wiles
|
| Vol #:
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| 280
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| EMC 7484
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| A. Generallo
|
| Vol #:
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| 280
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| EMC 7485
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| P. Loeff
|
| Vol #:
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| 280
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| EMC 7486
|
| E. McGary
|
| Vol #:
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| 280
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| EMC 7487
|
| G. Mangiantini
|
| Vol #:
|
| 280
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| EMC 7488
|
| J. Seron
|
| Vol #:
|
| 280
|
|
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| EMC 7489
|
| K. Troyan
|
| Vol #:
|
| 280
|
|
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| EMC 7490
|
| R. Natkin
|
| Vol #:
|
| 280
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|
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| EMC 7491
|
| K. Dahling
|
| Vol #:
|
| 280
|
|
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|
|
| EMC 7492
|
| A. Whisenhunt
|
| Vol #:
|
| 280
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| EC 493
|
| Ms. Lisa Dyer
|
| Vol #:
|
| 29
|
|
|
|
|
| 2002P-0406
|
| ANDA Suitability for Amoxicillin & Clavulanate Potassium
|
|
|
|
|
| C
4
Tabs
1-3, 4
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
|
|
| C
3
|
| CanReg, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C
4
|
| KV Pharmaceutical Company
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| Ropes & Gray, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0562
|
| Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
| EC 3
|
| Compliance Systems Resource
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EC 35
|
| Grocery Manufacturers of America
|
| Vol #:
|
| 8
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
| | | | | | | | |
|
|
|
|
| REF 1
|
| OMB review for June 16, 2004
|
| Vol #:
|
| 4
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| PDN
1
|
| HF-22 to Covington & Burling et al
|
| Vol #:
|
| 3
|
|
| |
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
|
|
| PDN
1
|
| HF-22 to Abbott Laboratories et al
|
| Vol #:
|
| 5
|
|
|
|
|
| 2004D-0082
|
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems; Availability
|
|
|
|
|
| EC 4
|
| AMERICAN FOOD COMPANY
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0166
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
|
|
|
|
|
| EC 5
|
| International Formula Council
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0176
|
| Preparation for the International Conference on Harmonization Meetings in Washington, DC: Public Meeting
|
|
|
|
|
| TR
1
|
| Transcripts
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| EC 2
|
| Coastal Consulting Group, Ltd.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| First Clinical Research
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0245
|
| Current Good Manufacturing Practice Regulations for Medicated Feeds, 21 CFR Part 225
|
|
|
|
|
| EC 1
|
| Miss. barb sachau
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0261
|
| Prevent Pfizer Inc. from marketing a generic version of Accupril until after the expiration of Teva's 180-day exclusivity period
|
|
|
|
|
| C
1
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CR
1
Tab A, B
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0180
|
| Qualified Health Claim (QHC): Lutein and Eye Diseases
|
|
|
|
|
| EC 7
|
| Mrs. Lori Short
|
| Vol #:
|
| 5
|
|
|
|
|
| EC 8
|
| Alcon
|
| Vol #:
|
| 5
|
|
|
|
|
| EC
9
References
|
| Kemin Foods, L.C.
|
| Vol #:
|
| 6
|
|
|
|
|
| EC 10
|
| Individual/Registered Dietitian
|
| Vol #:
|
| 5
|
|
|
|
|
| EC 11
|
| Ms. Lorna Williams
|
| Vol #:
|
| 5
|
|
|
|
|
| EC
12
Attachment
|
| DSM Nutritional Products, Inc.
|
| Vol #:
|
| 5
|
|
| |
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
|
|
| EC
44
Attachment
|
| American College of Surgeons
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
45
Attachment
|
| Advanced Medical Technology Association (AdvaMed)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
46
Attachment
|
| Medical Metrix Solutions
|
| Vol #:
|
| 1
|
|
