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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021496

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NDA 021496 describes DUOCAINE, which is a drug marketed by Amphastar Pharms Inc and is included in one NDA. Additional details are available on the DUOCAINE profile page.

The generic ingredient in DUOCAINE is bupivacaine hydrochloride; lidocaine hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the bupivacaine hydrochloride; lidocaine hydrochloride profile page.

Summary for 021496

Tradename:	DUOCAINE
Applicant:	Amphastar Pharms Inc
Ingredient:	bupivacaine hydrochloride; lidocaine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML)
Approval Date:	May 23, 2003	TE:		RLD:	No

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