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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Johnson & Johnson
Pediatric Exclusivity Granted Date:
02/08/2002
NNPS:
FALSE'
Therapeutic Category:
Urology
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