phentolamine mesylate

FDA Drug Profile — Ryzumvi

phentolamine mesylate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Ryzumvi. Available dosage form: solution/ drops.

Drug Details

Generic Name
phentolamine mesylate
Brand Names
Ryzumvi
Application Number
NDA217064
Sponsor
Oyster Point Pharma, Inc.
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
PHENTOLAMINE MESYLATE

Indications and Usage

1. INDICATONS AND USAGE OraVerse an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the 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. OraVerse, an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the 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. ( 1 )