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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 088653

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NDA 088653 describes POLOCAINE, which is a drug marketed by Dentsply Pharm and Fresenius Kabi Usa and is included in seven NDAs. It is available from two suppliers. Additional details are available on the POLOCAINE profile page.

The generic ingredient in POLOCAINE is levonordefrin; mepivacaine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.

Summary for 088653

Tradename:	POLOCAINE
Applicant:	Dentsply Pharm
Ingredient:	mepivacaine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 088653

Anesthetics, Local

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	3%
Approval Date:	Aug 21, 1984	TE:		RLD:	No

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