• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-