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| Dockets Entered
On October 14, 2003
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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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2001P-0323
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| Not rely on non-public filings to approve an innovator NDA;
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| 2001P-0447
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| Withdrawn for Safety or Effectivess of Ardeparin Sodium
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| 2002P-0377
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| Petition Requesting Stay of Approval of Mifeprex
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| 2002P-0447
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| Immediately revoke its acceptance for NDA 21-435 for amlodin
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| 2003N-0233
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
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| 2003N-0311
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| Agency Information Collection Activities: Proposed Collection; Comment Request; MDUFMA Small Business Qualification Certification (Form FDA 3602)
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| 2003N-0314
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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| 2003N-0429
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| Prescription Drug User Fee Act (PDUFA) III Five-Year Plan; Availability
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| 2003N-0456
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| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
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| 2003P-0408
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| Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11247
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| Ricola, Inc.
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| Vol #:
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| 86
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| LET
11248
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| Ricola Inc.
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| Vol #:
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| 86
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| LET
11249
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| Aboca USA Inc.
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| Vol #:
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| 86
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| LET
11250
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 86
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| LET
11251
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| Perrigo Company of South Carolina
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| Vol #:
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| 86
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| LET
11252
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| Perrigo Company of South Carolina
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| Vol #:
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| 86
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| LET
11253
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| PhytoPhgarmica Natural Medicines
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| Vol #:
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| 86
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| LET
11254
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 86
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| LET
11255
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 86
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| LET
11256
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| Enzymatic Therapy Natrual Medicines
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| Vol #:
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| 86
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| LET
11257
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 86
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| LET
11258
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 86
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| C
11
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| Compressed Gas Association
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| Vol #:
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| 3
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| C
12
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| Airgas, Inc.
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| Vol #:
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| 3
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| C
13
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| Duke Clinical Research Institute
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| Vol #:
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| 3
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| C
14
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| AGA Gas, Inc.
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| Vol #:
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| 3
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| C
15
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| Trimeris
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| Vol #:
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| 3
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| C
16
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| American Homepatient
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| Vol #:
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| 3
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| C
17
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| EMD Pharmaceuticals
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| Vol #:
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| 3
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| C
18
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| Goldsmith Pharmacovigilance and Systems
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| Vol #:
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| 3
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| C
19
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| College of American Pathologists
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| Vol #:
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| 3
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| C
20
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| Generic Pharmaceutical Association (GPhA)
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| Vol #:
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| 3
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| C
21
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| Applied Research Ethics National Association (Arena)
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| Vol #:
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| 3
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| C
22
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| American Association for Homecare
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| Vol #:
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| 3
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| C
23
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| Novartis Pharmaceuticals Corporation
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| Vol #:
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| 3
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| C
24
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| Genzyme Corporation
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| Vol #:
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| 4
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| C
25
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| Wyeth Research
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| Vol #:
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| 4
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| C
26
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| Johnson & Johnson
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| Vol #:
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| 4
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| C
27
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| Merck & Co. Inc.
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| Vol #:
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| 4
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| C
28
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 4
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| C
29
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| Abbott Laboratories
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| Vol #:
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| 4
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| C
30
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| Gas Regs, Inc.
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| Vol #:
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| 4
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| C
31
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| AstraZeneca LP
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| Vol #:
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| 4
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| C
32
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| American Red Cross
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| Vol #:
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| 4
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| 2001P-0323
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| Not rely on non-public filings to approve an innovator NDA;
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| C
6
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| Generic Pharmaceutical Association
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| Vol #:
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| 2
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| 2001P-0447
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| Withdrawn for Safety or Effectivess of Ardeparin Sodium
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| C 1
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| Generic Pharmaceutical Association
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| Vol #:
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| 2
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| MO
14
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| GCF-1 and Patton Boggs LLP
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| Vol #:
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| 1
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| 2002P-0377
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| Petition Requesting Stay of Approval of Mifeprex
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| C
3
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| Christian Medical Associatoin
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| Vol #:
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| 2
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| 2002P-0447
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| Immediately revoke its acceptance for NDA 21-435 for amlodin
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| C
3
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| Generic Pharmaceutical Association
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| Vol #:
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| 2
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| SS
1
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| SUPPORTING STATEMENT
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| Vol #:
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| 1
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0233
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
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| C
1
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| Merck KGaA
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| Vol #:
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| 1
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| C
2
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| CTFA & CHPA
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| Vol #:
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| 1
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| EXT
1
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| BASF AG & BASF Corporation
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| Vol #:
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| 1
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| 2003N-0311
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| Agency Information Collection Activities: Proposed Collection; Comment Request; MDUFMA Small Business Qualification Certification (Form FDA 3602)
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2003N-0314
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2003N-0429
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| Prescription Drug User Fee Act (PDUFA) III Five-Year Plan; Availability
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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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| 2003N-0456
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| Agency Information Collection:Prevention of Medical Gas Mix-ups at Health Care Facilities
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0408
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| Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets
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| C
2
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| Generic Pharmaceutical Association
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| Vol #:
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| 1
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