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| Dockets Entered
On September 28, 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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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-0307
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| Exports/Imports under FDA export reform/enhancement Act 1996
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|
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
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| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2007D-0249
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| 2007N-0330
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| Presidential Interagency Working Group on Import Safety; Public Meeting
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0130
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| Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| 2007P-0363
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| Prevent false and misleading labeling and ensure the safe and effacious use of dronibinol
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2445
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| Dr. Angela Gilley
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| Vol #:
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| 161
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|
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| EC 2446
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| Mrs. Felicia Czumble
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| Vol #:
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| 161
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| EC 2447
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| Ms. T Amar
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| Vol #:
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| 161
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| EC 2448
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| Miss. Minova Earle
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| Vol #:
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| 161
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|
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| EC 2449
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| D. Miller
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| Vol #:
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| 161
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|
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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|
| RPT 25
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| ROC
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| Vol #:
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| 1
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20877
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| Enzymatic
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| Vol #:
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| 181
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| LET 20878
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| Enzymatic
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| Vol #:
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| 181
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| LET 20879
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| Enzymatic
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| Vol #:
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| 181
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| LET 20880
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| Enzymatic
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| Vol #:
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| 181
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| LET 20881
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| Enzymatic
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| Vol #:
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| 181
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| LET 20882
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| Natural Organics, Inc.
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| Vol #:
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| 181
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| | | | | | | | |
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| LET 20883
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| Natural Organics, Inc.
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| Vol #:
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| 181
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| LET 20884
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| Natural Organics, Inc.
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| Vol #:
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| 181
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|
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| LET 20885
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| Natural Organics, Inc.
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| Vol #:
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| 181
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|
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| LET 20886
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| Natural Organics, Inc.
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| Vol #:
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| 181
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|
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| LET 20887
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| Natural Organics, Inc.
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| Vol #:
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| 181
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|
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| LET 20888
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| Natural Organics, Inc.
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| Vol #:
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| 181
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|
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| LET 20889
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| Natural Organics, Inc.
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| Vol #:
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| 181
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| LET 20890
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| Natural Organics, Inc.
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| Vol #:
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| 181
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|
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| LET 20891
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| Natural Organics, Inc.
|
| Vol #:
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| 181
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|
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| LET 20892
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| Natural Organics, Inc.
|
| Vol #:
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| 181
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|
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| LET 20893
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| NOW Foods
|
| Vol #:
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| 181
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|
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| LET 20894
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| NOW Foods
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| Vol #:
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| 181
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|
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| LET 20895
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| NOW Foods
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| Vol #:
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| 181
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|
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| LET 20896
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| NOW Foods
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| Vol #:
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| 181
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|
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| LET 20897
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| Natural Organics, Inc.
|
| Vol #:
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| 181
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|
|
| LET 20898
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| Shaklee
|
| Vol #:
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| 181
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|
|
| LET 20899
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| Enzymatic
|
| Vol #:
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| 181
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|
|
| LET 20900
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| Enzymatic
|
| Vol #:
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| 181
|
|
|
| LET 20901
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| Enzymatic
|
| Vol #:
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| 181
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|
|
| LET 20902
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| Enzymatic
|
| Vol #:
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| 181
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|
|
| LET 20903
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| Enzymatic
|
| Vol #:
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| 181
|
|
|
| LET 20904
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| Enzymatic
|
| Vol #:
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| 181
|
|
|
| LET 20905
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| Enzymatic
|
| Vol #:
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| 181
|
|
|
| LET 20906
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| Frutels, LLC
|
| Vol #:
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| 181
|
|
|
| LET 20907
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| PT Metrics LLC
|
| Vol #:
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| 181
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|
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| LET 20908
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| VitaGiant Laboratories, Inc.
|
| Vol #:
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| 181
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|
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| LET 20909
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| Market America, Inc.
|
| Vol #:
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| 181
|
|
|
| LET 20910
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| Market America, Inc.
|
| Vol #:
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| 181
|
|
|
| 1998D-0307
|
| Exports/Imports under FDA export reform/enhancement Act 1996
|
|
|
| EC 61
|
| Dr. A B
|
| Vol #:
|
| 1
|
|
|
| 2005P-0146
|
| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
|
|
|
|
| |
|
| SUP 4
|
| Salix Pharmaceuticals, Inc.
|
| Vol #:
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| 1
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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|
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| EC 124
|
| Agendia BV
|
| Vol #:
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| 3
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| | | | | | | | |
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| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
| C 3192
|
| S Severson
|
| Vol #:
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| 30
|
|
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| C 3193
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| M Pappenfus
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| Vol #:
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| 30
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|
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| C 3194
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| R Flood
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| Vol #:
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| 30
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|
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| C 3195
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| A Garner
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| Vol #:
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| 30
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|
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| C 3196
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| D Mix
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| Vol #:
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| 30
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|
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| C 3197
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| J Stocks
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| Vol #:
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| 30
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|
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| C 3198
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| E Hussin
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| Vol #:
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| 30
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|
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| C 3199
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| R Hein
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| Vol #:
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| 30
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|
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| C 3200
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| R Dunnam
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| Vol #:
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| 30
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|
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| C 3201
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| D McGinnis
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| Vol #:
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| 30
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|
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| C 3202
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| N Huckabee
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| Vol #:
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| 30
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|
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| C 3203
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| K Schexnider
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| Vol #:
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| 30
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|
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| C 3204
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| C Baisquet
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| Vol #:
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| 30
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|
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| C 3205
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| E Jenerose
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| Vol #:
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| 30
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|
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| C 3206
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| V Smith
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| Vol #:
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| 30
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|
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| C 3207
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| B Fischer
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| Vol #:
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| 30
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|
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| C 3208
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| C Davis
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| Vol #:
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| 30
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|
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| C 3209
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| J Buck
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| Vol #:
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| 30
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|
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| C 3210
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| A Harris
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| Vol #:
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| 30
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|
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| C 3211
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| K Shipman
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| Vol #:
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| 30
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|
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| C 3212
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| M Kettler
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| Vol #:
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| 30
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|
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| C 3213
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| B Troup
|
| Vol #:
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| 30
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|
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| C 3214
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| J Tullo
|
| Vol #:
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| 30
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|
|
| C 3215
|
| H Daniels Sr
|
| Vol #:
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| 30
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|
|
| C 3216
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| G Burger
|
| Vol #:
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| 30
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|
|
| C 3217
|
| H Stienstra
|
| Vol #:
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| 30
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|
|
| C 3218
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| L Harbin
|
| Vol #:
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| 30
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|
|
| C 3219
|
| B Rogers
|
| Vol #:
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| 30
|
|
|
| C 3220
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| B Barnett
|
| Vol #:
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| 30
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|
|
| C 3221
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| J Riehm
|
| Vol #:
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| 30
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|
|
| C 3222
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| V Wagner
|
| Vol #:
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| 30
|
|
|
| C 3223
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| C Bernard
|
| Vol #:
|
| 30
|
|
|
| C 3224
|
| F Hester
|
| Vol #:
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| 30
|
|
|
| C 3225
|
| C Thompson
|
| Vol #:
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| 30
|
|
|
| C 3226
|
| P Townsley
|
| Vol #:
|
| 30
|
|
| | | | | | | |
|
|
| C 3227
|
| B Cudo
|
| Vol #:
|
| 30
|
|
|
| C 3228
|
| M Baston
|
| Vol #:
|
| 30
|
|
|
| C 3229
|
| S Morgan
|
| Vol #:
|
| 30
|
|
|
| C 3230
|
| C Rice
|
| Vol #:
|
| 30
|
|
|
| C 3231
|
| B Borisoff
|
| Vol #:
|
| 30
|
|
|
| C 3232
|
| J Welpe
|
| Vol #:
|
| 30
|
|
|
| C 3233
|
| E Jackson
|
| Vol #:
|
| 30
|
|
|
| C 3234
|
| T Kidd
|
| Vol #:
|
| 30
|
|
|
| C 3235
|
| E Lanigan
|
| Vol #:
|
| 30
|
|
|
| C 3236
|
| B Harris
|
| Vol #:
|
| 30
|
|
|
| C 3237
|
| W O'Hara
|
| Vol #:
|
| 30
|
|
|
| C 3238
|
| T Prince
|
| Vol #:
|
| 30
|
|
|
| C 3239
|
| J Ley
|
| Vol #:
|
| 30
|
|
|
| C 3240
|
| J Plake
|
| Vol #:
|
| 30
|
|
|
| C 3241
|
| S Hale
|
| Vol #:
|
| 30
|
|
|
| C 3242
|
| R Orndorff
|
| Vol #:
|
| 30
|
|
|
| C 3243
|
| S Schnidt
|
| Vol #:
|
| 30
|
|
|
| C 3244
|
| D Rabasa
|
| Vol #:
|
| 30
|
|
|
| C 3245
|
| J Juliano
|
| Vol #:
|
| 30
|
|
|
| C 3246
|
| C Anderson
|
| Vol #:
|
| 30
|
|
|
| C 3247
|
| M Gibilterra
|
| Vol #:
|
| 30
|
|
|
| C 3248
|
| B Barwicks
|
| Vol #:
|
| 30
|
|
|
| C 3249
|
| F Del Buono
|
| Vol #:
|
| 30
|
|
|
| C 3250
|
| H Hoge
|
| Vol #:
|
| 30
|
|
|
| C 3251
|
| H Peyregne
|
| Vol #:
|
| 30
|
|
|
| C 3252
|
| M Petty
|
| Vol #:
|
| 30
|
|
|
| C 3253
|
| V Landes
|
| Vol #:
|
| 30
|
|
|
| C 3254
|
| L Cullen
|
| Vol #:
|
| 30
|
|
|
| C 3255
|
| S Schultz
|
| Vol #:
|
| 30
|
|
|
| C 3256
|
| R Dudek
|
| Vol #:
|
| 30
|
|
|
| C 3257
|
| R Phillips
|
| Vol #:
|
| 30
|
|
|
| C 3258
|
| J Baxter
|
| Vol #:
|
| 30
|
|
|
| C 3259
|
| M Osterberg
|
| Vol #:
|
| 30
|
|
|
| C 3260
|
| J Golden
|
| Vol #:
|
| 30
|
|
|
| C 3261
|
| B Critchell
|
| Vol #:
|
| 31
|
|
|
| C 3262
|
| Willson
|
| Vol #:
|
| 31
|
|
|
| C 3263
|
| L Williams
|
| Vol #:
|
| 31
|
|
| | | | | | | |
|
|
| C 3264
|
| R Lynch
|
| Vol #:
|
| 31
|
|
|
| C 3265
|
| H Mendel
|
| Vol #:
|
| 31
|
|
|
| C 3266
|
| N Leggett
|
| Vol #:
|
| 31
|
|
|
| C 3267
|
| J Fales
|
| Vol #:
|
| 31
|
|
|
| C 3268
|
| P Menon
|
| Vol #:
|
| 31
|
|
|
| C 3269
|
| M Colyer
|
| Vol #:
|
| 31
|
|
|
| C 3270
|
| P TatgenHorst
|
| Vol #:
|
| 31
|
|
|
| C 3271
|
| L Ross Jr
|
| Vol #:
|
| 31
|
|
|
| C 3272
|
| G Anderson
|
| Vol #:
|
| 31
|
|
|
| C 3273
|
| H Roske
|
| Vol #:
|
| 31
|
|
|
| C 3274
|
| D Hemmes
|
| Vol #:
|
| 31
|
|
|
| C 3275
|
| D Rienbolt
|
| Vol #:
|
| 31
|
|
|
| C 3276
|
| B Wetters
|
| Vol #:
|
| 31
|
|
|
| C 3277
|
| M Gottlieb
|
| Vol #:
|
| 31
|
|
|
| C 3278
|
| L Cranek
|
| Vol #:
|
| 31
|
|
|
| C 3279
|
| K Galbraith
|
| Vol #:
|
| 31
|
|
|
| C 3280
|
| C Butterfield
|
| Vol #:
|
| 31
|
|
|
| C 3281
|
| J Gibbons
|
| Vol #:
|
| 31
|
|
|
| C 3282
|
| M Burrow
|
| Vol #:
|
| 31
|
|
|
| C 3283
|
| M Goodwin
|
| Vol #:
|
| 31
|
|
|
| C 3284
|
| J Downs
|
| Vol #:
|
| 31
|
|
|
| C 3285
|
| M Micalizzi
|
| Vol #:
|
| 31
|
|
|
| C 3286
|
| G Haynes Sr
|
| Vol #:
|
| 31
|
|
|
| C 3287
|
| B Chain
|
| Vol #:
|
| 31
|
|
|
| C 3288
|
| J Vandelinde
|
| Vol #:
|
| 31
|
|
|
| C 3289
|
| W Persinger
|
| Vol #:
|
| 31
|
|
|
| C 3290
|
| C Ploehn
|
| Vol #:
|
| 31
|
|
|
| C 3291
|
| R Zender
|
| Vol #:
|
| 31
|
|
|
| C 3292
|
| B Wagner
|
| Vol #:
|
| 31
|
|
|
| C 3293
|
| D Burford
|
| Vol #:
|
| 31
|
|
|
| C 3294
|
| M Garrett
|
| Vol #:
|
| 31
|
|
|
| C 3295
|
| J Smith
|
| Vol #:
|
| 31
|
|
|
| C 3296
|
| Dixie Pediatrics
|
| Vol #:
|
| 31
|
|
|
| C 3297
|
| T Adams
|
| Vol #:
|
| 31
|
|
|
| C 3298
|
| C Logan
|
| Vol #:
|
| 31
|
|
|
| C 3299
|
| D Kolander
|
| Vol #:
|
| 31
|
|
| | | | | | | | |
|
|
| 2007D-0249
|
| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
|
|
|
| C 1
|
| Zimmer
|
| Vol #:
|
| 1
|
|
|
| 2007N-0321
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
|
|
|
|
| |
|
| EC 14
|
| State University of New York at Stonybrook
|
| Vol #:
|
| 1
|
|
|
| 2007N-0330
|
| Presidential Interagency Working Group on Import Safety; Public Meeting
|
|
|
| EC 115
|
| Mrs. Alice Potts
|
| Vol #:
|
| 1
|
|
|
| EC 116
|
| Steel Founders' Society of America
|
| Vol #:
|
| 1
|
|
|
| EC 117
|
| Philadelphia University
|
| Vol #:
|
| 1
|
|
|
| EC 118
|
| COTECNA, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 119
|
| VeritasAnalytics Inc
|
| Vol #:
|
| 1
|
|
|
| EC 120
|
| PakSense Inc.
|
| Vol #:
|
| 1
|
|
|
| EC 121
|
| Consumer Federation of America
|
| Vol #:
|
| 1
|
|
|
| EC 122
|
| Mr. gerald kucera
|
| Vol #:
|
| 1
|
|
|
| EC 123
|
| Mrs. Lenore Swanberg
|
| Vol #:
|
| 1
|
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
| |
|
| C 8
|
| James R. Forrester
|
| Vol #:
|
| 1
|
|
|
| C 9
|
| Mitchella Vineyard & Winery
|
| Vol #:
|
| 1
|
|
|
| C 10
|
| Christine Andrus
|
| Vol #:
|
| 1
|
|
|
| 2007P-0130
|
| Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate
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| WDL 1
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| Zydus Pharmaceuticals (USA) Inc.
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| Vol #:
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| 1
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| EC 2
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| KV Pharmaceutical Company
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| Vol #:
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| 1
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| EC 62
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| Dr. John Brady
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| Vol #:
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| 1
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| EC 63
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| Ms. Barbara Benton St. Gelais
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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 102
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| Mr. Randall Press
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| Vol #:
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| 1
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| EC 103
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| Mrs. Bonnie McGrath
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| Vol #:
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| 1
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| EC 104
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| Mr. Ernest Swauger
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| Vol #:
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| 1
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| EC 105
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| Mr. Steven Pintner
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| Vol #:
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| 1
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| EC 106
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| Mr. Mark Allen
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| Vol #:
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| 1
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| | | | | | | | |
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| EC 1
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| Ms. Aquene Freechild
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| Vol #:
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| 1
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| EC 2
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| Miss. Genni Chandler
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| Vol #:
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| 1
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| EC 3
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| Oregon Center for Environmental Health
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| Vol #:
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| 1
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| EC 4
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| Mr. Mike Purvis
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| Vol #:
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| 1
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| EC 5
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| Mr. Ralph Markey
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| Vol #:
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| 1
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| EC 6
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| Magee-Womens Hospital of UPMC
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| Vol #:
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| 1
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| EC 7
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| Ms. Roberta Anderson
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| Vol #:
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| 1
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| EC 8
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| Portland State University
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| Vol #:
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| 1
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| EC 9
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| Mr. Terry Crossett
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| Vol #:
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| 1
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| EC 10
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| Ms. g murphy
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| Vol #:
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| 1
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| 2007P-0333
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| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
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| EC 1
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| Mr. gerald kucera
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| Vol #:
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| 1
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| 2007P-0363
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| Prevent false and misleading labeling and ensure the safe and effacious use of dronibinol
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| ACK 1
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| FDA/DDM to Unimed Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| Unimed Pharmaceuticals, Inc.
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| Vol #:
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| 1
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