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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:
12/27/2007
Trade Name:
AndroGel
Generic Name or Proper Name (*):
testosterone
Indications Studied:
Use in adolescent boys with delayed puberty
Label Changes Summary:
Safety and efficacy in males < 18 years old have not been established Improper use may result in acceleration of bone age and premature closure of epiphyses
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Unimed
Pediatric Exclusivity Granted Date:
08/22/2007
NNPS:
FALSE'
Therapeutic Category:
Androgen-anabolic steroid
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