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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B) and PREA(P):
B,
Pediatric Rule (R):
40540
Sponsor:
Bausch and Lomb
Pediatric Exclusivity Granted Date:
12/28/2010
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, Antibiotic
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