CDERNEW-TEXT 9/20/2007
Friday, September 21, 2007
September 20, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ciclopirox Topical Solution, Synerx Pharma, Approval
Ciclopirox Topical Solution, Hi-Tech Pharmacal, Approval
Ciclopirox Topical Solution, Teva Pharma, Approval
Ciclopirox Topical Solution, G & W Labs, Approval
Ciclopirox Topical Solution, Taro Pharma, Approval
Ciclopirox Topical Solution, Watson Labs, Approval
Ciclopirox Topical Solution, Perrigo Co., Approval
Ciclopirox Topical Solution, Tolmar Inc., Approval
Ciclopirox Topical Solution, Apotex, Approval
Ciclopirox Topical Solution, Actavis, Approval
Colgate Total (sodium fluoride and triclosan dentifrice paste),
Colgate-Palmolive, Manufacturing Change or Addition
Kionex (Sodium Polystyrene Sulfonate) Suspension, Paddock Labs, Approval
MEFOXIN (cefoxitin sodium) Injection, Merck & Co., Labeling Revision
OsmoPrep (sodium phosphate monobasic monohydrate & sodium phosphate
dibasic anhydrous) Tablets, Salix Pharma, Labeling Revision
Ranitidine Syrup, Apotex, Approval
VANCOCIN HCL (vancomycin) Injection, Baxter Healthcare, Labeling
Revision
Warning Letter: Site Inspection, Kunshan Chemical & Pharmaceutical
Company http://www.fda.gov/cder/warn/warn2007.htm#September
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 10:10 AM,
