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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:
05/23/2003
Trade Name:
Duocaine Injection
Generic Name or Proper Name (*):
bupivacaine; lidocaine
Indications Studied:
Local regional anesthesia for ophthalmologic surgery by peripheral nerve block techniques in children 12 years of age and older
Label Changes Summary:
Safety and effectiveness extrapolated from existing clinical database Safety and effectiveness not established in patients < 12 years of age Partial waiver 0-12 years of age because general anesthesia is preferred in that population New active ingredient
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Amphastar
NNPS:
FALSE'
Therapeutic Category:
Anesthetic, topical
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