CDERNEW-TEXT 8/27/2007
Monday, August 27, 2007
August 27, 2007
Drug Master Files http://www.fda.gov/cder/dmf/index.htm
(updated)
Drug Shortage; Current; BiCNU
http://www.fda.gov/cder/drug/shortages/default.htm#Current
(updated)
International Conference on Harmonization (ICH) Public Meeting October
10, 2007, Rockville MD. Meeting information
http://www.fda.gov/cder/meeting/ICH_20071010.htm
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ammonia N 13 Injection, Feinstein Institute, Approval
Arthrotec (diclofenac sodium and misoprostol) Tablets, Pfizer, Inc.,
Labeling Revision
Carbidopa and Levodopa Extended Release Tablets, Sun Pharma, Approval
Carvedilol Tablets, Actavis Elizabeth, Tentative Approval
Carvedilol Tablets, Sandoz Inc., Tentative Approval
Clinoril (sulindac) Tablets, Merck & Co., Labeling Revision
Famciclovir Tablets, Teva Pharma, Approval
Glimepiride Tablets, Accord Healthcare, Approval
Quinapril Tablets, Invagen, Approval
Quinapril Hydrochloride Tablets, Teva Pharma, Approval
Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Aurobindo
Pharma, Approval
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posted by Mags @ 4:24 PM,
