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| Dockets Entered
On October 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1992S-0251
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| Electronic Submissions; Establishment of Public Docket
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005N-0209
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System
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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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| 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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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| 2005N-0396
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| Agency Information Collection Activities: Proposed Collection; Guidance on Formal Dispute Resolution; Appeals Above the Division Level
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| 2005P-0115
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| Immediately remove from the market pemoline CYLER- Abbott Laboratories, and all generic versions, a stimulant drug for the treatment of attention deficit hyperactivity disorder.
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 1976N-0052G
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| OTC general comments & combinations
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| C 230
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| R. Small, PharmD
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| Vol #:
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| 35
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| 1992S-0251
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| Electronic Submissions; Establishment of Public Docket
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| M
32
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| Content Labeling, 314.50(l), 314.94(d), 601.14(b), and 314.81(b)
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| Vol #:
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| 1
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| C
127
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| American Association for Respiratry Care (AARC)
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| Vol #:
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| 7
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16682
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16683
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16684
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16685
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16686
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16687
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16688
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16689
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16690
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16691
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16692
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16693
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16694
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16695
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16696
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16697
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16698
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16699
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16700
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| New Chapter, Inc.
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| Vol #:
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| 150
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| |
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| LET
16701
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16702
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16703
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| Enzymatic Therapy
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| Vol #:
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| 150
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| LET
16704
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| Enzymatic Therapy
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| Vol #:
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| 150
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| LET
16705
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16706
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| New Chapter, Inc.
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| Vol #:
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| 150
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| LET
16707
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| Enzymatic Therapy
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| Vol #:
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| 150
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| LET
16708
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| Herbsforever, Inc.
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| Vol #:
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| 150
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| 2004D-0283
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| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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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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| |
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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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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| |
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| RC
1
Tabs
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| Valeant Pharmaceuticals International
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| Vol #:
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| 2
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| |
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| C
7
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| C
1
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| Dartmouth-Hitchcock Medical Center
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| Vol #:
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| 3
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| 2005N-0209
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System
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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-0216
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
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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-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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|
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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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| |
|
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 145
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| R. Lewis
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| Vol #:
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| 14
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| C 146
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| H. Stanton, BSN
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| Vol #:
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| 14
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| C 147
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| A. William
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| Vol #:
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| 14
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| C 148
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| E and M Lendrat
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| Vol #:
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| 14
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| C
149
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| Planned Parenthood of Southwest and Central Florida, Inc.
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| Vol #:
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| 14
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| C
150
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| Planned Parenthood of Connecticut, Inc.
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| Vol #:
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| 14
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| C 151
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| C. Spencer
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| Vol #:
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| 14
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| C 152
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| D. Brian, PhD, CRNP
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| Vol #:
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| 14
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| C 153
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| K. Stefano
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| Vol #:
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| 14
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| C 154
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| C. Warren
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| Vol #:
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| 14
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| C 155
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| P. Flannery
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| Vol #:
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| 14
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| C 156
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| J. Maurus, M.D., M.P.H.
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| Vol #:
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| 14
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| C 157
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| A. Ravin, M.D.
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| Vol #:
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| 14
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| C 158
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| C. Feo
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| Vol #:
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| 14
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| C 159
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| H. McCarthy, Jr.
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| Vol #:
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| 14
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| C 160
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| J. and K. Lauber
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| Vol #:
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| 14
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| |
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| C 161
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| B. Neilan, M.D.
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| Vol #:
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| 15
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| C
162
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| Family Planning Council
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| Vol #:
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| 15
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| C 163
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| F. Slavin
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| Vol #:
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| 14
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| C
164
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| Emergency Contraception Access Campaign (ECAC)
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| Vol #:
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| 15
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| C
165
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| Emergency Contraception Access Campaign (ECAC)
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| Vol #:
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| 15
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| |
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| C 166
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| H. Tenaglio
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| Vol #:
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| 15
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| C 167
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| J. Dougherty
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| Vol #:
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| 15
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| |
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| C 168
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| B and A. Sheldon
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| Vol #:
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| 15
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| C 169
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| E. and D. Maier
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| Vol #:
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| 15
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| C 170
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| J. Williamson
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| Vol #:
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| 15
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| C 171
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| H and T Barrett
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| Vol #:
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| 15
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| |
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| C 172
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| B. Toth
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| Vol #:
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| 15
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| C 173
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| A. Welk
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| Vol #:
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| 15
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| C 174
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| M. Barchman
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| Vol #:
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| 15
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| C 175
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| F. Levito
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| Vol #:
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| 15
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| C 176
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| C. Shuck
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| Vol #:
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| 15
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| |
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| C 177
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| M. Petruska
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| Vol #:
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| 15
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| |
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| C 178
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| C. Scally
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| Vol #:
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| 15
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| |
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| C 179
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| F. Hiris
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| Vol #:
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| 15
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| |
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| C 180
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| Illegible
|
| Vol #:
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| 15
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| |
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| C 181
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| G. Matza
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| Vol #:
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| 15
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| C 182
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| F. Jackson
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| Vol #:
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| 15
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| C 183
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| T. Fuoco
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| Vol #:
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| 15
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| C 184
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| S. Cooney
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| Vol #:
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| 15
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| C 185
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| E. Simmonds
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| Vol #:
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| 15
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| C 186
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| M. Donnelly
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| Vol #:
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| 15
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| C 187
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| A. and F. Pugliese
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| Vol #:
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| 15
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| C 188
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| S. Zilora
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| Vol #:
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| 15
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| C 189
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| D. McAvoy
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| Vol #:
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| 15
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| C 190
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| B. Wismer
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| Vol #:
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| 15
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| C 191
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| A. Danday
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| Vol #:
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| 15
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| C 192
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| C. Cochran
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| Vol #:
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| 15
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| C 193
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| P. Pieri
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| Vol #:
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| 15
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| C 194
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| Eligible
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| Vol #:
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| 15
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| C 195
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| E. Berrodin
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| Vol #:
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| 15
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| C 196
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| M. D'Alessandro
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| Vol #:
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| 15
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| |
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| C 197
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| Illinois Planned Parenthood Council (IPPC)
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| Vol #:
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| 15
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| |
|
|
| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
| |
|
|
| ANS
1
|
| FDA to LifeMed Media Company
|
| Vol #:
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| 1
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| |
|
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| APE
2
|
| LifeMed Media Company
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0395
|
| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0396
|
| Agency Information Collection Activities: Proposed Collection; Guidance on Formal Dispute Resolution; Appeals Above the Division Level
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0008
|
| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
|
| |
|
|
| LET
2
|
| Teva Pharmaceuticals USA
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| 2005P-0046
|
| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
|
| |
|
|
| LET
1
|
| Teva Pharmaceuticals USA
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0115
|
| Immediately remove from the market pemoline CYLER- Abbott Laboratories, and all generic versions, a stimulant drug for the treatment of attention deficit hyperactivity disorder.
|
| |
|
|
| LET
2
|
| Public Citizen
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0430
|
| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
|
| |
|
|
| ACK
1
|
| HFA-305 to Gregory E. Skipper. M.D.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Gregory E. Skipper. M. D.
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| Vol #:
|
| 1
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|
