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Label Changes for:

Ditropan XL (oxybutynin chloride, USP) Extended Release tablets

July 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009


Postmarketing Surveillance
  • memory impairment
  • Cardiac Disorders: QT interval prolongation