Citanest Plain Dental

NDA 21382, held by Dentsply Pharm. Prilocaine Hydrochloride.

As of Nov 14, 2026, NDA 21382 (Citanest Plain Dental), held by Dentsply Pharm, was first approved by FDA on Nov 18, 1965, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 18, 1965
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 18, 1965	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Citanest Plain Dental4% · injectable;injection	Prilocaine Hydrochloride	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 18, 1965	Original application	Approved	None posted

Identifiers

Application: NDA 21382
Drugs@FDA: Overview at FDA
Company: Dentsply Pharmaceutical

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