Citanest, Citanest Plain, Citanest Forte

NDA 14763, held by Astrazeneca. Prilocaine Hydrochloride, Epinephrine Bitartrate; Prilocaine Hydrochloride.

As of Nov 13, 2026, NDA 14763 (Citanest, Citanest Plain, Citanest Forte), held by Astrazeneca, was first approved by FDA on Nov 18, 1965, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1965
Review: Priority
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Nov 18, 1965	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Citanest3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Prilocaine Hydrochloride	DiscontinuedReference drug
Citanest1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Prilocaine Hydrochloride	DiscontinuedReference drug
Citanest2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Prilocaine Hydrochloride	DiscontinuedReference drug
Citanest Plain4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Prilocaine Hydrochloride	DiscontinuedReference drug
Citanest Forte0.005MG/ML;4% · injectable;injection	Epinephrine Bitartrate; Prilocaine Hydrochloride	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 1, 2000	Supplement 36Manufacturing · Priority review	Approved	None posted
May 9, 1997	Supplement 34Labeling · Priority review	Approved	None posted
May 31, 1996	Supplement 35Manufacturing · Priority review	Approved	None posted
Mar 11, 1987	Supplement 26Labeling · Priority review	Approved	None posted
Aug 29, 1986	Supplement 24Labeling · Priority review	Approved	None posted
Mar 21, 1986	Supplement 25Labeling · Priority review	Approved	None posted
Mar 24, 1985	Supplement 21Labeling · Priority review	Approved	None posted
Mar 22, 1985	Supplement 22Labeling · Priority review	Approved	None posted
Jul 27, 1982	Supplement 19Labeling · Priority review	Approved	None posted
Jul 27, 1982	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 28, 1982	Supplement 23Manufacturing · Priority review	Approved	None posted
Aug 31, 1981	Supplement 20Labeling · Priority review	Approved	None posted
Aug 31, 1981	Supplement 17Manufacturing · Priority review	Approved	None posted
May 8, 1981	Supplement 16Manufacturing · Priority review	Approved	None posted
Aug 29, 1979	Supplement 15Labeling · Priority review	Approved	None posted
Apr 9, 1979	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 4, 1979	Supplement 14Labeling · Priority review	Approved	None posted
Mar 3, 1976	Supplement 11Labeling · Priority review	Approved	None posted
Mar 3, 1976	Supplement 10Manufacturing · Priority review	Approved	None posted
Nov 18, 1965	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 14763
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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