Nesacaine, Nesacaine-Mpf

NDA 9435, held by Fresenius Kabi USA. Chloroprocaine Hydrochloride.

As of Nov 14, 2026, NDA 9435 (Nesacaine, Nesacaine-Mpf), held by Fresenius Kabi USA, was first approved by FDA on Mar 11, 1955, with 32 approved supplements and 0 published complete response letters.

First approved: Mar 11, 1955
Review: Priority
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local anesthesia by infiltration and peripheral nerve block. They are not to be used for lumbar or caudal epidural anesthesia. Nesacaine-MPF 2% and 3% Injections, in single dose vials without preservative and without EDTA, are

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Mar 11, 1955	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

6 strengths and forms


Nesacaine1% · injectable;injection	Chloroprocaine Hydrochloride	DiscontinuedReference drug
Nesacaine2% · injectable;injection	Chloroprocaine Hydrochloride	RxReference drug
Nesacaine-Mpf2% · injectable;injection	Chloroprocaine Hydrochloride	Discontinued
Nesacaine-Mpf3% · injectable;injection	Chloroprocaine Hydrochloride	Discontinued
Nesacaine-Mpf2% · injectable;injection	Chloroprocaine Hydrochloride	RxReference drug
Nesacaine-Mpf3% · injectable;injection	Chloroprocaine Hydrochloride	RxReference drug

All 33 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 44Labeling · Standard review	Approved	Letter Label
Feb 16, 2013	Supplement 40Manufacturing · Priority review	Approved	None posted
Feb 19, 2010	Supplement 36Labeling · Priority review	Approved	Letter Label
Feb 19, 2010	Supplement 35Labeling	Approved	Letter Label
Jun 21, 2004	Supplement 34Labeling · Standard review	Approved	Letter Label
Feb 15, 2002	Supplement 33Manufacturing · Priority review	Approved	None posted
Nov 10, 2000	Supplement 32Labeling · Standard review	Approved	None posted
May 31, 1996	Supplement 31Manufacturing · Priority review	Approved	None posted
May 2, 1996	Supplement 30Manufacturing · Priority review	Approved	None posted
Apr 5, 1995	Supplement 29Manufacturing · Priority review	Approved	None posted
Apr 13, 1993	Supplement 28Manufacturing · Priority review	Approved	None posted
Aug 27, 1990	Supplement 27Manufacturing · Priority review	Approved	None posted
Mar 5, 1990	Supplement 26Manufacturing · Priority review	Approved	None posted
Aug 26, 1988	Supplement 25Labeling	Approved	None posted
Jul 30, 1987	Supplement 24Labeling	Approved	None posted
Jul 30, 1987	Supplement 23Labeling	Approved	None posted
Jul 30, 1987	Supplement 22Manufacturing · Priority review	Approved	None posted
Nov 14, 1986	Supplement 20Labeling	Approved	None posted
Aug 6, 1986	Supplement 21Manufacturing · Priority review	Approved	None posted
Jul 16, 1985	Supplement 16Labeling	Approved	None posted
Jul 16, 1985	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 16, 1985	Supplement 14Manufacturing · Priority review	Approved	None posted
Feb 12, 1982	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 12, 1982	Supplement 17Manufacturing · Priority review	Approved	None posted
Feb 23, 1981	Supplement 13Labeling	Approved	None posted
Feb 23, 1981	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 6, 1980	Supplement 8Labeling	Approved	None posted
Jun 13, 1979	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 27, 1979	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 16, 1976	Supplement 5Labeling	Approved	None posted
Mar 16, 1976	Supplement 4Labeling	Approved	None posted
Nov 15, 1974	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 11, 1955	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 9435
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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