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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:  10/18/2013
 
Trade Name:  Asacol HD
 
Generic Name or Proper Name (*):  mesalamine
 
Indications Studied:  Postmarketing study using Asacol
 
Label Changes Summary:  *Safety and effectiveness of Asacol HD in pediatric patients have not been established *Since studies were performed in Asacol rather than Asocol HD, information added to labeling referring reader to prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  P
 
Sponsor:  Warner Chilcott
 
NNPS:  TRUE
 
Therapeutic Category:  Anti-inflammatory
 
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