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| Dockets Entered
On November 5, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2006D-0108
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| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0412
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| Adolescent Over-the-Counter Drug Product Use
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| 2007P-0187
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| Requirements of Iodized Salt on Ingredient Labels
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0331
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| Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
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| 2007P-0435
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| Stay the effective date of any possible refusal of entry AQZ-0251619-6
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| 2007P-0436
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| Stay the effective date of any possible refusal of entry 595-4331551-5
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| 2007P-0437
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| To permit the filling of abberviated new drug applicacation (ANDA for Lopinavir/ritonavirtablets 100 mg/ 25 mg
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2626
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| Mrs. Janet Sanchez
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| Vol #:
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| 162
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| EC 2627
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| Ms. Joanne Behrens
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| Vol #:
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| 162
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| EC 2628
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| Mr. Mike Manzer
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| Vol #:
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| 162
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| EC 2629
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| Mr. Ed Hendricks
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| Vol #:
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| 162
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| EC 2630
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| Ms. Katharine Dahl
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| Vol #:
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| 162
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| EC 2631
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| Mrs. Dani Glaser
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| Vol #:
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| 162
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20969
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20970
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20971
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20972
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20973
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20974
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20975
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20976
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20977
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20978
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20979
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20980
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20981
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20982
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20983
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20984
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20985
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20986
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20987
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| Enz Matic Therapy
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| Vol #:
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| 182
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| LET 20988
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| Vita- Herbs, Inc.
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| Vol #:
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| 182
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| LET 20989
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| Herb Pharm
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| Vol #:
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| 182
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| LET 20990
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| Herb Pharm
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| Vol #:
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| 182
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| LET 20991
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| Iovate Health Sciences U. S. A., Inc.
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| Vol #:
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| 182
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| LET 20992
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20993
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20994
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20995
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20996
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20997
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20998
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| Enz Matic therapy
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| Vol #:
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| 182
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| LET 20999
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| Vita-Herbs, Inc.
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| Vol #:
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| 182
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| 2006D-0108
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| Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
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| EC 6
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| Mr. Jarad Hopper
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| Vol #:
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| 1
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| C 2
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| Plasma Protein Theraputics Association (PPTA)
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| Vol #:
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| 1
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| EC 15
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| GE Healthcare
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| EC 31
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| Westlake Drug, Inc.
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| Vol #:
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| 1
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| EC 32
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| Dr. Kenneth Ukauwa
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| Vol #:
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| 1
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| 2007N-0412
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| Adolescent Over-the-Counter Drug Product Use
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| EC 18
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| Public Citizen
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| Vol #:
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| 1
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| 2007P-0187
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| Requirements of Iodized Salt on Ingredient Labels
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| LET 1
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| Barbara O. Schneeman
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| Vol #:
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| 1
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| EC 132
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| Mr. Michael Danford
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| Vol #:
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| 1
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| 2007P-0331
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| Ban Use of Mercury In Medicine,UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic
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| EC 6
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| Mrs. Carrie Elsass
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| Vol #:
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| 1
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| EC 7
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| Mrs. Jimmie Sue Parker
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| Vol #:
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| 1
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| EC 8
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| n/a
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| Vol #:
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| 1
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| EC 9
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| Mrs. Brandye Bisek
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| Vol #:
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| 1
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| EC 10
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| Mrs. Susan Lambert
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| Vol #:
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| 1
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| 2007P-0435
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| Stay the effective date of any possible refusal of entry AQZ-0251619-6
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| ACK 1
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| FDA/DDM to Fuerst, Humphrey, Itlleman, PL
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| Vol #:
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| 1
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| LET 1
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| Thunder Bay Seafood Company
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| Vol #:
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| 1
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| PSA 1
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| Thunder Bay Seafood Company
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| Vol #:
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| 1
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| 2007P-0436
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| Stay the effective date of any possible refusal of entry 595-4331551-5
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| ACK 1
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| FDA/DDM to Fuerst, Humphrey, Itlleman, PL
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| Vol #:
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| 1
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| LET 1
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| Thunder Bay Seafood Company
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| Vol #:
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| 1
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| PSA 1
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| Thunder Bay Seafood Company
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| Vol #:
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| 1
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| 2007P-0437
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| To permit the filling of abberviated new drug applicacation (ANDA for Lopinavir/ritonavirtablets 100 mg/ 25 mg
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| ACK 1
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| FDA/ DDM/ to Matrix Laboratories, Inc.
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| Vol #:
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| 1
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| CP 1
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| Matrix Laboratories, Inc.
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| Vol #:
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| 1
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| ACK 1
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| FDA/DDM to National Toxic Encephalopathy Foundation
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| Vol #:
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| 1
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| CP 1
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| National Toxic Encephalopathy Foundation
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| Vol #:
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| 1
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