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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:  06/03/2010
 
Trade Name:  Zylet
 
Generic Name or Proper Name (*):  loteprednol etabonate and tobramycin
 
Indications Studied:  Eye lid inflammation
 
Label Changes Summary:  *Efficacy was not demonstrated in a study of pediatric patients 0-6 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,
 
Pediatric Rule (R):  12/28/2010
 
Sponsor:  Bausch and Lomb
 
Pediatric Exclusivity Granted Date:  12/28/2010
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, Antibiotic
 
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