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| Dockets Entered
On September 24, 2003
Table of Contents
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| Docket #
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| Title
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| 1992S-0251
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| Electronic Submissions; Establishment of Public Docket
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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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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| 1998V-0454
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| Laser light show
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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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-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0060
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| Part11, Electronic records, electronic signatures scope
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| 2003D-0226
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| Compliance with Sec 301 of the Medical Device User Fee and Modernization Act of 2002 b Identification of Manufacturer of Medical Devices; Availability
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| 2003N-0059
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| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
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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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| 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-0338
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| Secretary's Roundtable on Obesity/Nutrition
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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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-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0315
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| Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug
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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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| 2003P-0436
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| (ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone
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| 2003P-0437
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| refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03
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| 2003P-0438
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| change the regulatory status of prenatal listening devices commonly called "Doppler Fetoscopes" under 21 CFR 5.10
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| 2003P-0439
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| Elective Refractive Eye Surgery with Premarket Approvals (PMAs)
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| 2003P-0441
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| ANDA suitability for metoprolol tartrate 12.5 mg tablets
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| 2003V-0371
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| Laser Light Show
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| 2003V-0378
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| Laser Light Show
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| 2003V-0394
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| Laser Light Show
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| 2003V-0395
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| Laser Light Show
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| 2003V-0440
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| Laser Light Show
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| 1992S-0251
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| Electronic Submissions; Establishment of Public Docket
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| M
28
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| Postmarketing Expedited & Period Individual Case Safety Reports
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11027
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| Cell Tech International Incorporated
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| Vol #:
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| 84
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| LET
11028
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11029
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11030
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11031
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11032
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11033
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11034
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11035
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11036
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11037
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11038
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11039
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11040
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11041
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| Solstic Medicine Company
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| Vol #:
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| 84
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| LET
11042
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| Solstice Medicine Company
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| Vol #:
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| 84
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| LET
11043
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| Solstice Medicine Company
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| Vol #:
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| 84
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
719
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| HFS-800 to Hyman, Phelps & McNamara for Purac Biochem bv
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| Vol #:
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| 22
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| LET
720
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| HFS-800 to Essere Corporation
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| Vol #:
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| 22
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| LET
721
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| HFS-800 to Immundyne
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| Vol #:
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| 22
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| LET
722
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| HFS-800 to Nutrition21
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| Vol #:
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| 22
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| LET
723
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| HFS-800 to Arkopharma, LLC
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| Vol #:
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| 22
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7030
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| Ann Marie Gumula
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| Vol #:
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| 299
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| C 7031
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| Lisa Blake
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| Vol #:
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| 299
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| C 7032
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| Hugh Jones & Carolyn Parker
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| Vol #:
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| 299
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| C 7033
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| Michael Farner, MD.
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| Vol #:
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| 299
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| C 7034
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| Mary Pearson
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| Vol #:
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| 299
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| C 7035
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| Darcy Miller
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| Vol #:
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| 299
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| C 7036
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| no signature
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| Vol #:
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| 299
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| C 7037
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| Holly & Graham Gurry & Family
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| Vol #:
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| 299
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| C 7038
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| Rebecca Blechman
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| Vol #:
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| 299
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| EMC 3638
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| Comcast
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| Vol #:
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| 295
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| EMC 3639
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| Ms. Deborah Manz
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| Vol #:
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| 295
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| EMC 3640
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| Chad Lupkes
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| Vol #:
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| 295
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| EMC 3641
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| Roxanne Russin
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| Vol #:
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| 295
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| EMC 7032
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| Hugh Jones & Carolyn Parker
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| Vol #:
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| 299
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| 1998V-0454
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| Laser light show
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| VRA
3
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| HFZ-300 to Universal Orlanda (formerly Universal Studios Florida)
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| Vol #:
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| 1
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C
34
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| American Dairy Products Institute
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| Vol #:
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| 2
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| LET
2
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| HFS-800 to American Dairy Products Institute
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| Vol #:
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| 2
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 128
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| Barb Wilkie
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| Vol #:
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| 3
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| EMC 129
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| Fara Barnes
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| Vol #:
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| 3
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| CS
16
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| HFA-305
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| Vol #:
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| 1
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| MO
13
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| GCF-1 and Patton Boggs LLP
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| Vol #:
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| 1
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| OR
14
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| HF-3
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 271
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| Betty Martini
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| Vol #:
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| 5
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| EMC 272
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| Betty Martini
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| Vol #:
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| 5
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| 2003D-0060
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| Part11, Electronic records, electronic signatures scope
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| GDL 3
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| number not used
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| Vol #:
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| 6
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| NAD 3
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| number not used
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| Vol #:
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| 6
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| |
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| 2003D-0226
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| Compliance with Sec 301 of the Medical Device User Fee and Modernization Act of 2002 b Identification of Manufacturer of Medical Devices; Availability
|
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| C
2
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| Colgate-Palmolive Company
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| Vol #:
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| 1
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| C
3
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| The Cosmetic, Toiletry, and Fragrace Assn (CTFA)
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| Vol #:
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| 1
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| C
4
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| Cypress Medical Products
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| Vol #:
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| 1
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| |
|
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| 2003N-0016
|
| MedWatch: The FDA Medical Products Reporting Program
|
| |
|
|
| M
1
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| HFZ-510 to Dockets Management Branch
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| Vol #:
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| 1
|
| |
|
|
| 2003N-0059
|
| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
|
| |
|
|
| C
3
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| Aventis Pasteur, Inc.
|
| Vol #:
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| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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|
| | | | | | | | |
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| EXT
3
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| Institute of Shortening and Edible Oils, Inc.
|
| Vol #:
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| 1
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| |
|
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| 2003N-0314
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
|
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|
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| C
1
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| Pharmavite, LLC
|
| Vol #:
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| 1
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| |
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| 2003N-0338
|
| Secretary's Roundtable on Obesity/Nutrition
|
| |
|
|
| EMC
2
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| Harvard School of Public Health
|
| Vol #:
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| 1
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| |
|
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| TR 1
|
| Transcript of the July 30, 2003 Secretary's Roundtable on Obesity/Nutrition
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| Vol #:
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| 2
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| |
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| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
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| APE 14
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| Lacuna Research Limited
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| Vol #:
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| 1
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| APE 15
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| Appleton Security Products
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| Vol #:
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| 1
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| APE 16
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| NHK Spring Co., Ltd
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| Vol #:
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| 1
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| APE 17
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| Bsecure Ltd
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| Vol #:
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| 1
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| APE 18
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| NoCopi Technologies, Inc
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| Vol #:
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| 1
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| APE 19
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| IntelliDOT Corporation
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| Vol #:
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| 1
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| APE 20
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| Pharmaceutical Distributors Association
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| Vol #:
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| 1
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| APE 21
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| Alcan Packaging Pharma Center
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| Vol #:
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| 1
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| |
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| LET 1
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| Bruce Krichmar
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| Vol #:
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| 1
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| |
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| NM
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
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| RPT
1
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| National Economic Research Associates, Inc.
|
| Vol #:
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| 1
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| |
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| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
| |
|
|
| LET
1
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| HFD-6 to King Pharmaaceuticals Inc
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| Vol #:
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| 1
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| |
|
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| |
|
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| C
1
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| National Breast Cancer Coalition
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| Vol #:
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| 1
|
| |
|
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| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
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| |
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| C 45
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| David P. Alan, O.D.
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| Vol #:
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| 1
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| |
|
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| 2003P-0315
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| Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug
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| |
|
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| C 1
|
| Mutual Pharmaceutical Company, Inc.
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| Vol #:
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| 1
|
| |
|
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| 2003P-0408
|
| 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
|
| |
|
|
| SUP
1
Tab A
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| TorPharm, Inc. (TorPharm)
|
| Vol #:
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| 1
|
| |
|
|
| 2003P-0436
|
| (ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone
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| |
|
|
| CP
1
Attachment
1, 2, 3
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| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2003P-0437
|
| refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03
|
| |
|
|
| ACK
1
|
| HFA-305 to Public Citizen Litigation Group
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| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Public Citizen Litigation Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0438
|
| change the regulatory status of prenatal listening devices commonly called "Doppler Fetoscopes" under 21 CFR 5.10
|
| |
|
|
| ACK 1
|
| HFA-305 to Russel J. Thomsen, MD
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Russel J. Thomsen, MD
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0439
|
| Elective Refractive Eye Surgery with Premarket Approvals (PMAs)
|
| |
|
|
| ACK 1
|
| HFA-305 to Dominic J. Morgan
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Dominic J. Morgan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0441
|
| ANDA suitability for metoprolol tartrate 12.5 mg tablets
|
| |
|
|
| ACK 1
|
| HFA-305 to Nabeal M. Saif, R.Ph.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Nabeal M. Saif, R.Ph.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0371
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to ECSU Planetarium, Elizabeth City State University
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0378
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Northway Lanes
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0394
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to XO
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0395
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Lunar Bowl
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0440
|
| Laser Light Show
|
| |
|
|
| VAR
1
|
| Area 54 DJ Co.
|
| Vol #:
|
| 1
|
|
|
