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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:
03/21/2017
Trade Name:
Ciloxan ophthalmic solution
Generic Name or Proper Name (*):
ciprofloxacin
Indications Studied:
Bacterial conjunctivitis in pediatric patients less than 1 month old
Label Changes Summary:
*Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days.
Product Labeling:
Labeling
BPCA(B):
P
BPCA(B) and PREA(P):
B
Sponsor:
Alcon
Pediatric Exclusivity Granted Date:
01/10/2003
NNPS:
FALSE
Therapeutic Category:
Antibiotic, topical
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