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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:
05/13/2005
Trade Name:
Ortho Tri-Cyclen
Generic Name or Proper Name (*):
norgestimate/ ethinyl estradiol
Indications Studied:
Evaluation of total hip bone mineral density in adolescent females with anorexia nervosa
Label Changes Summary:
No significant difference between Ortho Tri-Cyclen and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year clinical trial
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Ortho McNeil
Pediatric Exclusivity Granted Date:
12/18/2003
NNPS:
FALSE'
Therapeutic Category:
Contraceptive
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