Citanest Forte Dental

NDA 21383, held by Dentsply Pharm. Epinephrine Bitartrate; Prilocaine Hydrochloride.

As of Nov 15, 2026, NDA 21383 (Citanest Forte Dental), held by Dentsply Pharm, was first approved by FDA on Nov 18, 1965, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1965
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Citanest Forte Dental0.005MG/ML;4% · injectable;injection	Epinephrine Bitartrate; Prilocaine Hydrochloride	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Nov 3, 2021	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 2, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 3, 2015	Supplement 9Manufacturing	Approved	None posted
Aug 29, 2014	Supplement 8Manufacturing	Approved	None posted
Nov 18, 1965	Original application	Approved	None posted

Identifiers

Application: NDA 21383
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