Last Updated: September 24, 2026

Details for New Drug Application (NDA): 017751

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NDA 017751 describes DURANEST, which is a drug marketed by Astrazeneca and Dentsply Pharm and is included in two NDAs. Additional details are available on the DURANEST profile page.

The generic ingredient in DURANEST is etidocaine hydrochloride. There are three drug master file entries for this compound. Additional details are available on the etidocaine hydrochloride profile page.

Summary for 017751

Tradename:	DURANEST
Applicant:	Astrazeneca
Ingredient:	etidocaine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 017751

Anesthetics, Local

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017751

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-005	Approved Prior to Jan 1, 1982	4,254,114	⤷ Start Trial
Astrazeneca	DURANEST	epinephrine; etidocaine hydrochloride	INJECTABLE;INJECTION	017751-004	Approved Prior to Jan 1, 1982	3,812,147	⤷ Start Trial
Astrazeneca	DURANEST	etidocaine hydrochloride	INJECTABLE;INJECTION	017751-003	Approved Prior to Jan 1, 1982	3,862,321	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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