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Drug Evaluation & Research

CDERNEW-TEXT 9/4/2007

Wednesday, September 5, 2007

September 4, 2007

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Ranitidine Hydrochloride Tablets, Dr. Reddy's Labs, Approval

Trileptal (oxcarbazepine) Oral Solution, Novartis Pharma, Labeling
Revision

Trileptal (oxcarbazepine) Tablets, Novartis Pharma, Labeling Revision

Ultravist (brand of iopromide) Injection, Bayer HealthCare Pharma,
Labeling Revision

Pediatric Research Equity Act (PREA) Labeling Changes
http://www.fda.gov/cder/pediatric/Prea_label_post-mar_2_mtg.htm
(updated)

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posted by Mags @ 11:58 AM,

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