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Dockets Management
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| Dockets Entered On
June 14, 2006
Table of Contents
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1998N-1109
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| Mercury Compounds in Drugs and Food
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2002E-0100
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| Patent Application for Dutrasteride
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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-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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| 2006FL-0238
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| Food Allergen Labeling Petition (FALP): Culture Media with Enzyme-Treated Soy Solids
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| NFR 4
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| FDA
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| NFR 5
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| FDA
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| Vol #:
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| 10
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| 1998N-1109
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| Mercury Compounds in Drugs and Food
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| LET 6
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| Howard Rice Nemerovski Canady Falk & Rabkin
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| Vol #:
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| 2
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| LST 5
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| Mercury in Drug and Biologic Products List - Update
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| Vol #:
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| 2
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| ANS 1
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| FDA/OES to National Medical Association
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| Vol #:
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| 1
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| C 85
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| National Medical Association
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| Vol #:
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| 1
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| 2002E-0100
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| Patent Application for Dutrasteride
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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-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| SUP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 12654
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| J. P. Tofte
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| Vol #:
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| 152
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| C 12655
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| B. R. Scott
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| Vol #:
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| 152
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| C 12656
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| M.C. Oty
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| Vol #:
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| 152
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| C 12657
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| E. Hunt
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| Vol #:
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| 152
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| C 12806
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| P. Adams
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| Vol #:
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| 153
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| C 12807
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| H. Geraci
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| Vol #:
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| 153
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| C 12808
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| D. S. Meyer
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| Vol #:
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| 153
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| C 12809
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| S. Henderson
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| Vol #:
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| 153
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| C 12810
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| C. Stiefel
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| Vol #:
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| 153
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| C 12811
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| B. M. Border
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| Vol #:
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| 153
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| C 12812
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| C. Huelsmann
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| Vol #:
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| 153
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| C 12813
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| F. Womack
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| Vol #:
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| 153
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| C 12814
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| C. Lawrence
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| Vol #:
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| 153
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| C 12815
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| B. Rosenshein
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| Vol #:
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| 153
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| C 12816
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| F. Tablas
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| Vol #:
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| 153
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| C 12817
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| J. A. Levin
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| Vol #:
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| 153
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| C 12818
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| M. Bolton
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| Vol #:
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| 153
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| C 12819
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| L. Schlenker
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| Vol #:
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| 153
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| C 12820
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| J. Sussman
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| Vol #:
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| 153
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| C 12821
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| P. Carlstrom
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| Vol #:
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| 153
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| C 12822
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| D. Duncan
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| Vol #:
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| 153
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| C 12823
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| M. Davenport
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| Vol #:
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| 153
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| C 12824
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| J. Duree
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| Vol #:
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| 153
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; 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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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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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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| 2006FL-0238
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| Food Allergen Labeling Petition (FALP): Culture Media with Enzyme-Treated Soy Solids
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| CP 1
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| International Media and Cultures (IMAC)
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| Vol #:
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| 1
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| C 2
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| 13 signatures
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| Vol #:
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| 1
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| ACK 1
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| FDA/ DDM to Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 1
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