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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:
Zymar Ophthalmic Solution
Generic Name or Proper Name (*):
gatifloxacin
Indications Studied:
Bacterial conjunctivitis in pediatric patients less than 1 month of age
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) and PREA(P):
B
Sponsor:
Allergan
Pediatric Exclusivity Granted Date:
05/19/2009
NNPS:
FALSE
Therapeutic Category:
Antibiotic, topical
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