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| Dockets Entered
On June 16, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1991N-0384H
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| Nutrient Content Claims, Definition of Term: Healthy
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| 1992N-0391
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| Analysis of Adverse Reactions to Monosodium Glutamate (MSG)
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| 1996P-0500
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| Amend "Healthy" Definition re: Sodium Levels
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2004N-0441
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
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| 2004P-0085
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| Esmolol Hydrochloride for injection ,2,500 mg/vital in a lyophilized form is suitable for evaluation under an ANDA
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| 2004P-0173
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| ANDA for Cefprozil Tablets for Oral Suspension, 125 mg and 250 mg
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| 2004P-0220
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| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| 2005E-0239
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| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| 2005N-0124
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
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| 2005N-0208
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
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| 2005N-0216
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
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| 2005P-0237
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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| LET 1
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| Number not used
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| Vol #:
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| 142
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| 1991N-0384H
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| Nutrient Content Claims, Definition of Term: Healthy
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| C
133
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| Campbell Soup Company
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| Vol #:
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| 13
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| 1992N-0391
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| Analysis of Adverse Reactions to Monosodium Glutamate (MSG)
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| C 246
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| B. Walters
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| Vol #:
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| 18
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| 1996P-0500
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| Amend "Healthy" Definition re: Sodium Levels
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| C
43
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| Campbell Soup Company
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| Vol #:
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| 10
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16207
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16208
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16209
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16210
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16211
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16212
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16213
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET
16214
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| USA CTT Co., Inc.
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| Vol #:
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| 144
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| LET
16215
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| Shining Mountain herbs
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| Vol #:
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| 144
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| LET
16216
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| Natural Organics Inc.
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| Vol #:
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| 144
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| LET
16217
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| Natural Organics Inc.
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| Vol #:
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| 144
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| LET
16218
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| Natural Organics Inc.
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| Vol #:
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| 144
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| LET
16219
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| Natural Organics Inc.
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| Vol #:
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| 144
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| LET
16220
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 144
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| LET
16221
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| RAND Research Laboratories TM,LLC
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| Vol #:
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| 144
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| LET
16222
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| Klein-Becker usa TM, LLC
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| Vol #:
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| 144
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| LET
16223
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| Dynakor Pharmacal TM, LLC
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| Vol #:
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| 144
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| LET
16224
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| SilverSage TM, LLC
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| Vol #:
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| 144
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| LET
16225
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| CNS, Inc.
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| Vol #:
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| 144
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| LET
16226
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 144
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| LET
16227
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 144
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| LET
16228
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 144
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| LET
16229
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 144
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18233
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| D. Weaver
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| Vol #:
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| 516
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| 2004N-0441
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
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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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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004P-0085
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| Esmolol Hydrochloride for injection ,2,500 mg/vital in a lyophilized form is suitable for evaluation under an ANDA
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| PDN
1
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| HFD-7 to Bedford Laboratories
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| Vol #:
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| 1
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| 2004P-0173
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| ANDA for Cefprozil Tablets for Oral Suspension, 125 mg and 250 mg
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| PDN
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0220
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| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
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| PDN
1
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| HFD-7 to Wapner, Newman, Esq.
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| Vol #:
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| 1
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| C
5
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| GlaxoSmithKline
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| Vol #:
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| 2
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| APP
1
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| Athena Neurosciences, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005E-0239
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| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| APP
1
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| ELAN Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2005N-0124
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
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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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| 2005N-0208
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
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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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| 2005N-0216
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
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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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| 2005P-0237
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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
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| ACK
1
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| HFA-305 to Pharmaceutical Patent Attorneys, LLC
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| Vol #:
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| 1
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| CP
1
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| Pharmaceutical Patent Attorneys, LLC
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| Vol #:
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| 1
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