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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:  08/11/2000
 
Trade Name:  Lodine XL
 
Generic Name or Proper Name (*):  etodolac
 
Indications Studied:  Relief of signs & symptoms of Juvenile Rheumatoid Arthritis
 
Label Changes Summary:  * New indication in 6 years -16 years * Higher dose (per kg basis) in younger children which is approximately 2 times the lower dose recommended for adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Wyeth Ayerst
 
Pediatric Exclusivity Granted Date:  12/06/1999
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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