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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:  09/09/2015
 
Trade Name:  Delzicol
 
Generic Name or Proper Name (*):  mesalamine**
 
Indications Studied:  Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older
 
Label Changes Summary:  *Expanded the indication to pediatric patients 5 years and older; previously approved in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 5 years have not been established. *Two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. *For patients unable to swallow the capsules whole, information on opening the capsule(s) and swallowing the contents. *New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Warner Chilcott
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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