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| Dockets Entered
On June 22, 2005
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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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 2003P-0501
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| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| 2005E-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| 2005E-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| 2005E-0250
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| Patent Term Extension Application for NSURE U.S. Patent No. 4,600,706
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| 2005E-0251
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| 2005E-0252
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| 2005E-0254
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| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
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| 2005E-0255
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| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
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| 2005E-0256
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| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
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| 2005E-0258
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| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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| 2005N-0190
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
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| 2005N-0220
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16231
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| Orthlo Molecular Products
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| Vol #:
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| 144
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| LET
16232
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| Ortho Molecular Products
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| Vol #:
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| 144
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| LET
16233
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| Ortho Molecular Products, Inc.
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| Vol #:
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| 144
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
829
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| HFS-800 to Lidtke Technologies Corporation
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| Vol #:
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| 25
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| LET
830
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| HFS-800 to Market America Inc
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| Vol #:
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| 25
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| LET
831
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| HFS-800 to MD Drinks Inc
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| Vol #:
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| 25
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| LET
832
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| HFS-800 to Organix South Inc
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| Vol #:
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| 25
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| 2003P-0501
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| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
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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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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| APP
1
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| Harald Breivik et al
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| Vol #:
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| 1
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| APP 2
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| Number not used
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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-0248
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| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| APP
1
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| Shire International Licensing B.V
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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-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| APP
1
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| Novartis International Pharmaceutical Ltd.
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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-0250
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| Patent Term Extension Application for NSURE U.S. Patent No. 4,600,706
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| APP
1
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| Arkion Life Sciences LLC
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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-0251
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| APP
1
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| Astellas Pharma 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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| 2005E-0252
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
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| APP
1
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| Astellas Pharma 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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| 2005E-0253
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| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| APP
1
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| OSI 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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| 2005E-0254
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| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
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| APP
1
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| ImClone Systems Incorporated
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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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| 2005E-0255
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| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
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| APP
1
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| Sepracor 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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| 2005E-0256
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| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
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| APP
1
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| Genzyme Corporation
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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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| 2005E-0258
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| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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| APP
1
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| Harald Breivik et al
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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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| 2005N-0190
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
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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-0220
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor
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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-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| RC
1
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| Barbara and Kirk Van Rooyan, M.D.
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| Vol #:
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| 1
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| SUP
2
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| Intracoastal Arthritis & Rheumatology
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| Vol #:
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| 1
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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| CP
1
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| The Weinberg Group Inc.
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| Vol #:
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| 1
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