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| Dockets Entered On
October 6, 2005
Table of Contents
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| Docket #
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| Title
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1996N-0277
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| Eligibility Criteria for Considering Additional Condition
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004P-0236
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| Revoke the Authority for Industry to Use Partially Hydrogenated Vegetable Oils in Foods
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0391
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| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
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| 2005M-0399
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| P020016 - Total Temporomandibular Joint Replacement System, Approved 9/21/05
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005P-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| 2005P-0408
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| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
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| 2005P-0409
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| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| C
91
Attachment
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| Soap and Detergent Association (SDA) & Cosmetic, Toiletry, and Fragrance Association (CTFA)
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| Vol #:
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| 200
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT
759
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| Statistical Report, Month of September 2005
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| Vol #:
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| 54
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| 1996N-0277
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| Eligibility Criteria for Considering Additional Condition
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| LET
16
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| HFD-560 to Sue Ismiel & Daughters US Inc
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| Vol #:
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| 5
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16593
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16594
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16595
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16596
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16597
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16598
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16599
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16600
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16601
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16602
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| Apex Fiitness Group
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| Vol #:
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| 149
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| LET
16603
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16604
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16605
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16606
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16607
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16608
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16609
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16610
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16611
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16612
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16613
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16614
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| Apex Fitness Group
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| Vol #:
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| 149
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| LET
16615
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| Source Naturals
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| Vol #:
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| 149
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| BKG 1
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| Refs 1 - 36
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| Vol #:
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| 6
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| NPR 1
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| FDA
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| Vol #:
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| 6
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
8
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| Amphastar Pharmaceuticals Inc
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| Vol #:
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| 6
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| 2004P-0236
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| Revoke the Authority for Industry to Use Partially Hydrogenated Vegetable Oils in Foods
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| EMC 1
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| T. Sonnabend
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| Vol #:
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| 1
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| EMC 2
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| F Melione
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| Vol #:
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| 1
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| EMC 351
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| K Krause-Kimmel
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| Vol #:
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| 9
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| WDL
1
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| The Solae Company
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| Vol #:
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| 9
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| 2005D-0391
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| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0399
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| P020016 - Total Temporomandibular Joint Replacement System, Approved 9/21/05
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| AAV
1
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| Walter Lorenz Surgical, Inc.
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| Vol #:
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| 1
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| APE 1
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| K Witczak
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| Vol #:
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| 1
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| APE 2
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| E Swan
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| Vol #:
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| 1
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| APE 3
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| E Liversidge
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| Vol #:
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| 1
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| 2005P-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| ACK
1
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| HFA-305 to Mr. Robert W. Pollock
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| Vol #:
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| 1
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| 2005P-0408
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| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
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| ACK 1
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| HFA-305 to Dan M. Kelch
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| Vol #:
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| 1
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| CP 1
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| Dan M. Kelch
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| Vol #:
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| 1
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| 2005P-0409
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| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
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| ACK
1
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| HFA-305 to Sterne, Kessler, Goldstein & Fox, P.L.L.C.
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| Vol #:
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| 1
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| CP
1
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| Sterne, Kessler, Goldstein & Fox, P.L.L.C.
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| Vol #:
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| 1
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