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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Amphastar
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic, topical
 
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