Last Updated: November 8, 2026

Details for New Drug Application (NDA): 080384

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NDA 080384 describes PROCAINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Bel Mar, Elkins Sinn, Gd Searle Llc, Hospira, Miles, and Watson Labs, and is included in twelve NDAs. Additional details are available on the PROCAINE HYDROCHLORIDE profile page.

The generic ingredient in PROCAINE HYDROCHLORIDE is epinephrine; procaine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the epinephrine; procaine hydrochloride profile page.

Summary for 080384

Tradename:	PROCAINE HYDROCHLORIDE
Applicant:	Abraxis Pharm
Ingredient:	procaine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 080384

Anesthetics, Local

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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