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FDADocs 5/9/2008 | 0 (0) | 17 | 0 | 0 | English
.......--.....SENT BY: FDA COMPLIANCE;5042534520 ;J UN. 7 - 04 1 0 : 04AM;PAGE 3/4DEPARTMENT OF HF,AJ, TH ANn mJMAN SFRVTCFFood andD~'ug' AdmjnistrationNew Or183"8 Dl8trlc ... more>>
FDADocs 5/9/2008 | 0 (0) | 26 | 0 | 0 | English
(8-12-03) TABLETSPCC 630100CRESTOR??(rosuvastatin calcium) DESCRIPTION CRESTOR?? (rosuvastatin calcium) is a synthetic lipid-lowering agent. Rosuvastatin is an inhibitor ... ... more>>
FDADocs 5/9/2008 | 0 (0) | 28 | 0 | 0 | English
, :Regulatory Consultant FDA Experts 3509 W. Beverly Blvd., Montebello, California 90640Dear Ms Gomez ... more>>
FDADocs 5/9/2008 | 0 (0) | 36 | 1 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 33 | 0 | 0 | English
FDA Executive Summary Prepared for the November 9, 2006 Dental Products Panel Company: Device... Graft is a combination product consisting of a device and a biologic drug. FDA has determined that ... more>>
FDADocs 5/9/2008 | 0 (0) | 33 | 0 | 0 | English
FDA Executive Summary (Version 2) Prepared for the March 27, 2006, meeting of the Obstetrics & Gynecology Devices Panel P050011 Innovata plc ?? Adept Adhesion Reduction Solution (4% Icodextrin ... more>>
FDADocs 5/9/2008 | 0 (0) | 22 | 0 | 0 | English
NDA 20-717/S-019November 2005SPARLON??? (modafinil) Tablets [C-IV]Rx OnlyDESCRIPTION SPARLON (modafinil) is an orally administered agent for the treatment of Attent... ... more>>
FDADocs 5/9/2008 | 0 (0) | 65 | 0 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceDivision of Dermatologic and Dental Drug Products Office of Drug Evaluation V Center for Drug Evaluation and Research F... ... more>>
FDADocs 5/9/2008 | 0 (0) | 61 | 1 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceDivision of Dermatologic and Dental Drug Products Office of Drug Evaluation III Center for Drug Evaluation and Research... ... more>>
FDADocs 5/9/2008 | 0 (0) | 50 | 0 | 0 | English
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmacoepidemiology and Statistical Science Office of B... ... more>>
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MEMORANDUMDEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHDATE: FROM:October 19, 2005 ... ... more>>
FDADocs 5/9/2008 | 0 (0) | 60 | 0 | 0 | English
MEMORANDUMDEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHDATE: FROM:March 3, 2006 Tho... ... more>>
FDADocs 5/9/2008 | 0 (0) | 92 | 0 | 0 | English
MEMORANDUMDEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHDATE: FROM:October 12, 2005 ... ... more>>
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