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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  04/15/2003
Trade Name:  Ditropan & Ditropan XL
Generic Name or Proper Name (*):  oxybutynin
Indications Studied:  Detrusor Overactivity Associated with a Neurological Condition
Label Changes Summary:  Ditropan * Additional information on dose and PK parameters * Precautions section of label updated Ditropan XL * Safety and effectiveness established down to 6 years of age
Product Labeling:  Labeling  Opens a new window
Sponsor:  Johnson & Johnson
Pediatric Exclusivity Granted Date:  02/08/2002
Therapeutic Category:  Urology