Oraverse

NDA 22159, held by Septodont Holding. Phentolamine Mesylate.

As of Nov 14, 2026, NDA 22159 (Oraverse), held by Septodont Holding, was first approved by FDA on May 9, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: May 9, 2008
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Mar 18, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review
May 9, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Pediatric Statistical Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oraverse0.4MG/1.7ML · injectable;injection	Phentolamine Mesylate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Mar 18, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review
Jan 7, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 26, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 26, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 9, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 9, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 9, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
May 9, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Pediatric Statistical Review

Identifiers

Application: NDA 22159
Drugs@FDA: Overview at FDA
Company: Septodont Holding

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters