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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
 
BPCA(B):  B
 
Sponsor:  Johnson & Johnson
 
Pediatric Exclusivity Granted Date:  02/08/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Urology
 
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