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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:
10/07/2008
Trade Name:
Akten Ophthalmic gel 3.5%
Generic Name or Proper Name (*):
lidocaine hydrochloride
Indications Studied:
Ocular surface anesthesia during ophthalmologic procedures
Label Changes Summary:
Safety and efficacy extrapolated from studies in adults and older pediatric patients using different ophthalmic formulations of lidocaine. New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Akorn
NNPS:
TRUE'
Therapeutic Category:
Anesthetic, topical
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