| 2004Q-0100
|
| Qualified Health Claim:
Calcium and bone fractures
|
|
|
|
|
|
|
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim:
Calcium and Kidney/urinary stones
|
|
|
| 1993N-0480O
|
| Health Claims;
Omega-3 Fatty Acids & CHD
|
|
|
| MT
1
|
| HFS-832 to Emord & Associates,
PC
|
| Vol #:
|
| 1
|
|
|
| 1993N-0480Z
|
| Health Claims for
Zinc & Immune Deficiency in Elderly
|
|
|
| MT
1
|
| HFS-832 to Emord & Associates,
PC
|
| Vol #:
|
| 1
|
|
|
| 1997P-0197
|
| Require that warning
labels about risks of salmonella enteri
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|
|
| C
829
Signatures
|
| Center for Science in the Public
Interest (CSPI)
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| Vol #:
|
| 30
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
13258
|
| pH Sciences
|
| Vol #:
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| 109
|
|
|
| LET
13259
|
| pH Sciences
|
| Vol #:
|
| 109
|
|
|
| LET
13260
|
| Natrol, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13261
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13262
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13263
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13264
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13265
|
| FreeLife LLC
|
| Vol #:
|
| 109
|
|
|
| LET
13266
|
| Source Naturals
|
| Vol #:
|
| 109
|
|
|
| LET
13267
|
| Life Source, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13268
|
| Life Source, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13269
|
| Life Source, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13270
|
| Life Source, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13271
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 109
|
|
|
| LET
13272
|
| NEK Products, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13273
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13274
|
| Body Wise International, Inc.
|
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|
| 109
|
|
|
| LET
13275
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13276
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13277
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13278
|
| Body Wise International, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13279
|
| Alva-Amco Pharmacal Companies,
Inc.
|
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|
| 109
|
|
|
| LET
13280
|
| Supernatural Health, Inc.
|
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|
| 109
|
|
|
| LET
13281
|
| MuscleTech Research and Development,
Inc.
|
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|
| 109
|
|
|
| LET
13282
|
| Optimum Nutrition
|
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| 109
|
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|
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|
|
|
| LET
13283
|
| Lane Labs USA, Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13284
|
| Lidtke Technologies
|
| Vol #:
|
| 109
|
|
|
| LET
13285
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 109
|
|
|
| LET
13286
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 109
|
|
|
| LET
13287
|
| Shaklee Corporation
|
| Vol #:
|
| 109
|
|
|
| LET
13288
|
| Shaklee Corporation
|
| Vol #:
|
| 109
|
|
|
| LET
13289
|
| Nature's Answer Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13290
|
| Metagenics Inc.
|
| Vol #:
|
| 109
|
|
|
| LET
13291
|
| Leiner Health Prorducts
|
| Vol #:
|
| 109
|
|
|
| LET
13292
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 109
|
|
|
| 1998P-0504
|
| Raw Molluscan Shellfish
of Undetectable Levels
|
|
|
| C
269
Signatures
|
| Center for Science in the Public
Interest (CSPI)
|
| Vol #:
|
| 18
|
|
|
| 1999N-4282
|
| Biotechnology in
the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18224
|
| D. Shively
|
| Vol #:
|
| 516
|
|
|
| 1999P-3029
|
| Health Claim: Folic
Acid, Vitamin B6 etc & Vascular Disease
|
|
|
| MT
1
|
| HFS-832 to Emord & Associates,
PC
|
| Vol #:
|
| 13
|
|
|
| 1999P-5332
|
| Amend limit Hydrogenated
& partially Hydrogenated Menhaden O
|
|
|
| C
5
|
| Omega Protein Corporation
|
| Vol #:
|
| 1
|
|
|
| 2000N-1571
|
| Enrofloxacin for
Poultry: Opportunity for Hearing
|
|
|
| CS
48
|
| HFA-305
|
| Vol #:
|
| 389
|
|
|
| IDF
1
|
| HF-3
|
| Vol #:
|
| 389
|
|
|
| 2000P-1322
|
| Food Labeling and
Allergen Contamination Control
|
|
| C 543
|
| R. Jasinski, MD
|
| Vol #:
|
| 30
|
|
|
| LET
5
|
| Center for Science in the Public
Interest (CSPI)
|
| Vol #:
|
| 30
|
|
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| 2001P-0075
|
| Switch Status of
Emergency Contraceptives from Rx to OTC
|
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| C 367
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| B. Calhoun,MD,FACOG,FACS
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| 162
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| 169
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| EMC 4534
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| M. Ball
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| 169
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| EMC 4535
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| K A Schuck
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| 169
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| EMC 4536
|
| D. Dixon
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| Vol #:
|
| 169
|
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| EMC 4537
|
| M. Kirwin
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| 169
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| EMC 4538
|
| T. St. Clair
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| Vol #:
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| 169
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| EMC 4539
|
| L. Pearson
|
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| 169
|
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| EMC 4540
|
| M. Morgan
|
| Vol #:
|
| 169
|
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| EMC 4541
|
| R. Michaels
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| 169
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|
| EMC 4542
|
| J. Pasiuk
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| 169
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| EMC 4543
|
| G. Beason
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| 169
|
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| EMC 4544
|
| B. Jastromb
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| Vol #:
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| 169
|
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| EMC 4545
|
| M. Giresi
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| Vol #:
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| 169
|
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| EMC 4546
|
| K. Baker
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| 169
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| EMC 4547
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| J. Thomas
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| 169
|
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| EMC 4548
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| R. E. Dritz
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| 169
|
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| EMC 4549
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| O. Z. White
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| 169
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| EMC 4550
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| S. Farrington
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| 169
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| EMC 4551
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| J. Meyer
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| 169
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| EMC 4552
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| A. Richards
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| 169
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| EMC 4553
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| D. J. Goldberg
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| 169
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| EMC 4554
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| K. Fine
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| 169
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| EMC 4555
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| E. Beaven
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| 169
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| EMC 4556
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| M. Gannon
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| 169
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| EMC 4557
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| J. Wilson
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| 169
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| EMC 4558
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| C. Normand
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| 169
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| EMC 4559
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| S. Johnston
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| 169
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| EMC 4560
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| C. Kilgore-Hadley
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| 169
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| EMC 4561
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| L. Mann
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| 169
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| EMC 4562
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| K. Forrette
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| 169
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| EMC 4563
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| F. Williams
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| 169
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| EMC 4564
|
| B. Ercoline
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| 169
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| EMC 4565
|
| E. Watkins
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| 169
|
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| EMC 4566
|
| M. Easter-Dawson
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| 169
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| EMC 4567
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| N. Zeidan
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| 169
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| EMC 4568
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| L. Sawyer
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| 169
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| EMC 4569
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| T. A. Smagola
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| 169
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| EMC 4570
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| J. Diamond
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| 169
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| EMC 4571
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| D. L. Binkele
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| 169
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| EMC 4572
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| R. Palm
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| 169
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| EMC 4573
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| M. Wozniak
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| 169
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| EMC 4574
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| C. Garcia
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| 169
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| EMC 4575
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| S. Repan
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| 169
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| EMC 4576
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| J. Michel
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| 169
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| EMC 4577
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| E. Walrack
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| 169
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| EMC 4578
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| C. Moore
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| 169
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| EMC 4579
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| Dr. R. A. Fischer
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| 169
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| EMC 4580
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| J. Thomas
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| 169
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| EMC 4581
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| A. Strickland
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| 169
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| EMC 4582
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| S. Kaufman
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| 169
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| EMC 4583
|
| H. Z. Spagna
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| 169
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| EMC 4584
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| A. Robinson
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| 169
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| EMC 4585
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| A. Kellgren
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| 169
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| EMC 4586
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| D. McElroy
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| 169
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| EMC 4587
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| C. Woodworth
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| 169
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| EMC 4588
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| E. Smolinski
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| 169
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| EMC 4589
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| J. Kowal
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| 169
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| EMC 4590
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| K. Hetrick
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| 169
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| EMC 4591
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| R. Kowal
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| 169
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| EMC 4592
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| K. O'Connor
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| 169
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| EMC 4593
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| G. Linx
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| 169
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| EMC 4594
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| A. Kilzer
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| 169
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| EMC 4595
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| R. Clouser
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| 169
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| EMC 4596
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| J. J. Tuinstra
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| 169
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| EMC 4597
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| G. Ortiz
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| 169
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| EMC 4598
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| N. C. Westfall
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| 169
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| EMC 4599
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| P. De Moor
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| Vol #:
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| 169
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| EMC 4600
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| B. Peterson
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| 169
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| EMC 4601
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| P. Palmer
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| 169
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| EMC 4602
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| M. Agee
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| Vol #:
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| 169
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| EMC 4603
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| L. M. lamerand
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| 169
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| EMC 4604
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| M. Adrian
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| 169
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| EMC 4605
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| B. Flores
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| 169
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| EMC 4606
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| M.Masi
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| 169
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| EMC 4607
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| D. Brown
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| 169
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| EMC 4608
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| M. Lipow
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| 169
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| EMC 4609
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| J. Gharibian
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| 169
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| EMC 4610
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| F. Thomas
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| Vol #:
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| 169
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| EMC 4611
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| D. Jones
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| 169
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| EMC 4612
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| R. Lanza
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| 169
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| EMC 4613
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| V. Rivers
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| 169
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| EMC 4614
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| A. McKune
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| 169
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| EMC 4615
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| L. Friedman
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| 169
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| EMC 4616
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| C. Aken
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| 169
|
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| EMC 4617
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| B. Zdrojewski
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| 169
|
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| EMC 4618
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| A. Avilie
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| Vol #:
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| 169
|
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| EMC 4619
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| P. Koteles
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| Vol #:
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| 169
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| EMC 4620
|
| V. A. Lavin
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| Vol #:
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| 169
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| EMC 4621
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| K. Coughlan
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| 169
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| EMC 4622
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| B. E. Young
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| 169
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| EMC 4623
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| M. Martin
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| 169
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| EMC 4624
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| P. C. Rogers
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| EMC 4625
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| A. Griffin
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| Vol #:
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| 169
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| 2002N-0277
|
| Bioterrorism; Establishment
& Maintenance of Records
|
|
|
| REF 1
|
| OMB Review May 9, 2003
|
| Vol #:
|
| 17
|
|
|
| 2002P-0292
|
| Health Claims:
Walnuts & Cornary Disease
|
|
|
| LET
10
|
| HFS-200 to Covington & Burling
|
| Vol #:
|
| 6
|
|
|
| 2003D-0522
|
| Draft Guidance
for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations
for Drugs of Abuse Screening Tests; Availability
|
|
|
| C 10
|
| J. Baker
|
| Vol #:
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| 1
|
|
|
| C 11
|
| Illegible
|
| Vol #:
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| 1
|
|
|
| 2003D-0570
|
| Draft on the Clinical
Evaluation of Weight-Control Drugs
|
|
|
| C
1
|
| American Obesity Assn (AOA)
|
| Vol #:
|
| 1
|
|
|
| 2003E-0406
|
| Patent Term Restoration
Application for Fabrazime, U.S. Patent No. 5,356,804
|
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|
| N
1
|
| FDA
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| Vol #:
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| 1
|
|
|
| 2003E-0411
|
| Patent Term Restoration
Application for Facitive (gemifloxacin mesylate), U.S. Patent No.
5,633, 262
|
|
|
| N
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|
| FDA
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| Vol #:
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| 1
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| 2003E-0416
|
| Zelnorm (Tegaserod
Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
|
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|
| N
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|
| FDA
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| Vol #:
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| 1
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| 2003E-0448
|
| Patent Extension
for FACTIVE, gemifloxacin mesylate, #5,776,944
|
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|
| N
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|
| FDA
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| Vol #:
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| 1
|
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|
| 2003E-0449
|
| Patent Extension
for FACTIVE, gemifloxacin mesylate, #5,962,468
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| N
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|
| FDA
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| Vol #:
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| 1
|
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| 2003N-0076
|
| Food Labeling:
Trans Fatty Acids in Nutrition Labeling; Consumer research to consider
possible footnote statements
|
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| C 14
|
| J. Olsen, RD
|
| Vol #:
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| 3
|
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| C 15
|
| M. Rosen
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| 1
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|
|
| C 16
|
| S. Nally
|
| Vol #:
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| 3
|
|
|
| C 17
|
| M. Slining
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| Vol #:
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| 3
|
|
|
| 2003N-0170
|
| Report on the Performance
of Drug and Biologics Firms in Conducting Postmarketing Commitment
Studies; AvailabilityACTION: Notice of availability.
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003P-0126
|
| Refrain from approving
(ANDA)for Levothyroxine Sodium Tablet
|
|
|
| LET
3
|
| Hogan & Hartson, LLP
|
| Vol #:
|
| 1
|
|
|
| 2003P-0276
|
| Establish Interim
Acceptable Levels for Acrylamide In Major Food Sources
|
|
|
| C
2
Signatures
|
| Cneter for Science in the Public
Interest (CSPI)
|
| Vol #:
|
| 1
|
|
|
| 2003P-0387
|
| Request that the
Commissioner of Food and Drug take action described methodology for
oral levothyroxine sodium drug products
|
|
|
| LET
3
|
| Hogan & Hartson, LLP
|
| Vol #:
|
| 3
|
|
|
| 2003P-0393
|
| Diazepam Injection
USP, 5 mg/mL, 1-mL,(ANDA No. 72-079), by Abbott laboratories, Inc.,
has been voluntarily withdrawn or withheld from sale for safety or
efficacy reasons
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2003P-0479
|
| Allow importation
of Canadian versions of drugs that are approved to the United States
|
|
|
| C 1
|
| G. McClary
|
| Vol #:
|
| 1
|
|
|
| C 2
|
| L and D McDowell
|
| Vol #:
|
| 1
|
|
|
| C 3
|
| No signature
|
| Vol #:
|
| 1
|
|
|
| C 4
|
| D. DuBois
|
| Vol #:
|
| 1
|
|
|
| C 5
|
| J. Dunn, Jr.
|
| Vol #:
|
| 1
|
|
|
| C 6
|
| M. Klein, MD
|
| Vol #:
|
| 1
|
|
|
| C 7
|
| E. Koch
|
| Vol #:
|
| 1
|
|
|
| C 8
|
| D. Schoen
|
| Vol #:
|
| 1
|
|
|
| C 9
|
| A. Pennignton
|
| Vol #:
|
| 1
|
|
|
| C 10
|
| F. Smith
|
| Vol #:
|
| 1
|
|
|
| C 11
|
| P. Burton
|
| Vol #:
|
| 1
|
|
|
| C 12
|
| T. Torblch, Jr.
|
| Vol #:
|
| 1
|
|
|
| C 13
|
| E. Petroske
|
| Vol #:
|
| 1
|
|
|
| C 14
|
| P. Press
|
| Vol #:
|
| 1
|
|
|
| C 15
|
| H. Schiffman
|
| Vol #:
|
| 1
|
|
|
|
|
|
|
|
|
|
|
|
|
| C 16
|
| I. Segalman
|
| Vol #:
|
| 1
|
|
|
| C 17
|
| M. Schoenbrun
|
| Vol #:
|
| 1
|
|
|
| C 18
|
| Form Letters
|
| Vol #:
|
| 2
|
|
|
| C 19
|
| Form Letters
|
| Vol #:
|
| 3
|
|
|
| 2004D-0028
|
| Draft Consumer
Advisory regarding Advice for Subgroups of a Population regarding
Mercury in Fish and Shellfish
|
|
|
| C 11
|
| S. Alcorn
|
| Vol #:
|
| 1
|
|
|
| C 12
|
| J. Fritz
|
| Vol #:
|
| 1
|
|
|
| C 13
|
| H. Cipolle
|
| Vol #:
|
| 1
|
|
|
| C 14
|
| R. Austin
|
| Vol #:
|
| 1
|
|
|
| C 15
|
| D. Moore
|
| Vol #:
|
| 1
|
|
|
| C 16
|
| L. Keir
|
| Vol #:
|
| 1
|
|
|
| C 17
|
| P. Leslie
|
| Vol #:
|
| 1
|
|
|
| C 18
|
| G. Powers
|
| Vol #:
|
| 1
|
|
|
| C 19
|
| S. Roh
|
| Vol #:
|
| 1
|
|
|
| C 20
|
| K. Brady
|
| Vol #:
|
| 1
|
|
|
| C 21
|
| J. Mcachaughton
|
| Vol #:
|
| 1
|
|
|
| C 22
|
| EB Meade
|
| Vol #:
|
| 1
|
|
|
| C 23
|
| M. Hartell
|
| Vol #:
|
| 1
|
|
|
| C 24
|
| M. Naoll
|
| Vol #:
|
| 1
|
|
|
| C 25
|
| L. Gray
|
| Vol #:
|
| 1
|
|
|
| C 26
|
| A. Yule
|
| Vol #:
|
| 1
|
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
|
|
| C
1
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 4
|
|
|
| 2004N-0049
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Control of Communicable Diseases; Restrictions on African Rodents,
Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
| C 1
|
| J. Korsmo
|
| Vol #:
|
| 1
|
|
|
| 2004P-0003
|
| Petition to reconsider
the Food and Drug Administration's decision on the Med Watch complaint
|
|
|
| LET 1
|
| Billy G. Pierson
|
| Vol #:
|
| 1
|
|
|
| 2004P-0127
|
| ANADA suitability
for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats
(NADA 120-161)
|
|
|
| ACK
1
|
| HFA-305 to Smart Drug Systems,
Inc.
|
| Vol #:
|
| 1
|
|
|
| CP
1
Generic Label
Pioneer Label
|
| Smart Drug Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0128
|
| ANADA for clavamox
(amoxicillin trihydrate/clavulanate potassium) tablets for dogs and
cats
|
|
|
| ACK
1
|
| HFA-305 to Smart Drug Systems,
Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
|
|
|
|
|
|
|
|
| CP
1
Tab 1, Tab
2
|
| Smart Drug Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004Q-0097
|
| Qualified Health
Claim: Calcium and various cancers
|
|
|
| ACK
1
|
| HFS-255 to Emord & Associate
PC
|
| Vol #:
|
| 15
|
|
|
| LET
1
|
| HFS-800 to Emord & Associate
PC
|
| Vol #:
|
| 15
|
|
|
| LET
2
|
| Marine Bio USA Inc
|
| Vol #:
|
| 15
|
|
|
| QHC
1
Exhibit
1, 2-6
|
| Marine Bio USA Inc
|
| Vol #:
|
| 1
|
|
|
| SUP
1
References
|
| Marine Bio USA Inc
|
| Vol #:
|
| 16
|
|
|
| 2004Q-0098
|
| Qualified Health
Claim: Calcium and hypertension
|
|
|
| ACK
1
|
| HFS-830 to Marine Bio USA Inc
|
| Vol #:
|
| 9
|
|
|
| LET
1
|
| HFS-800 to Marine Bio USA Inc
|
| Vol #:
|
| 9
|
|
|
| LET
2
|
| Marine Bio USA Inc
|
| Vol #:
|
| 9
|
|
|
| LET
3
|
| Marine Bio USA Inc
|
| Vol #:
|
| 9
|
|
|
| LET
4
|
| Marine Bio USA Inc
|
| Vol #:
|
| 9
|
|
|
| QHC
1
Exhibit
1, 2-7
|
| Marine Bio USA Inc
|
| Vol #:
|
| 1
|
|
|
| SUP
1
References
|
| Marine Bio USA Inc
|
| Vol #:
|
| 10
|
|
|
| 2004Q-0099
|
| Qualified Health
Claim: Calcium and menstrual disorders
|
|
|
| ACK
1
|
| HFS-830 to Emord & Associates
Inc
|
| Vol #:
|
| 4
|
|
|
| LET
1
|
| HFS-800 to Emord & Associates
|
| Vol #:
|
| 4
|
|
|
| LET
2
|
| Marine Bio USA Inc
|
| Vol #:
|
| 4
|
|
|
| QHC
1
Exhibit
1, 2-7
|
| Marine Bio USA, Inc
|
| Vol #:
|
| 1
|
|
|
| SUP
1
References
|
| Marine Bio USA Inc
|
| Vol #:
|
| 5
|
|
|
| 2004Q-0100
|
| Qualified Health
Claim: Calcium and bone fractures
|
|
|
| ACK
1
|
| HFS-830 to Emord & Associats
Inc
|
| Vol #:
|
| 6
|
|
|
| LET
1
|
| HFS-800 to Emord & Associates,
PC
|
| Vol #:
|
| 6
|
|
|
| LET
2
|
| Marine Bio USA Inc
|
| Vol #:
|
| 6
|
|
|
| QHC
1
Exhibit
1, 2-5
|
| Marine Bio USA, Inc
|
| Vol #:
|
| 2
|
|
|
| SUP
1
References
|
| Marine Bio USA Inc
|
| Vol #:
|
| 7
|
|
|
| 2004Q-0102
|
| Qualified Health
Claim: Calcium and Kidney/urinary stones
|
|
|
| ACK
1
|
| HFS-830 to Emord & Associates,
PC
|
| Vol #:
|
| 6
|
|
|
| LET
1
|
| HFS-800 to Emord & Associates,
PC
|
| Vol #:
|
| 6
|
|
|
| LET
2
|
| Marine Bio USA Inc
|
| Vol #:
|
| 6
|
|
|
| QHC
1
Exhibit
1, 2-5
|
| Marine Bio USA, Inc
|
| Vol #:
|
| 1
|
|
|