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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Ortho McNeil
 
Pediatric Exclusivity Granted Date:  12/18/2003
 
NNPS:  FALSE'
 
Therapeutic Category:  Contraceptive
 
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