CDERNEW-TEXT 9/5/2007
Thursday, September 6, 2007
September 5, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Magnevist (gadopentetate dimeglumine) Injection, Bayer HealthCare,
Labeling Revision
Mirtazapine Orally Disintegrating Tablets, Actavis Elizabeth, Tentative
Approval
MultiHance (gadobenate dimeglumine) Injection, Bracco Diagnostics,
Labeling Revision
MultiHance (gadobenate dimeglumine) Multipack Injection, Bracco
Diagnostics, Labeling Revision
Nystatin /Triamcinolone Acetonide Cream, Taro Pharma, Facility Addition
OptiMARK (gadoversetamide) Injection, Mallinckrodt Inc., Labeling
Revision
ProHance (gadoteridol) Injection, Bracco Diagnostics, Labeling Revision
Proquin (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed
Inc., Labeling Revision
Voltaren (diclofenac sodium) Ophthalmic Solution, Novartis Pharma,
Labeling Revision
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posted by Mags @ 9:23 AM,
