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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
05/09/2008
Trade Name:
OraVerse Injection 0.4 mg (0.235 mg/mL)
Generic or Proper Name (*):
phentolamine mesylate
Indications Studied:
Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor
Therapeutic Category:
Anesthetic, topical
Ages Studied:
3 years and older
Study #:
5
Study Type:
Safety/Pharmacokinetic
Study Design:
Open Label/Traditional Pharmacokinetic
No Patients:
19
No Centers:
3
No Countries:
1
BPCA(B), PREA(P):
P
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