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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 020997

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NDA 020997 describes CHIROCAINE, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. Additional details are available on the CHIROCAINE profile page.

The generic ingredient in CHIROCAINE is levobupivacaine hydrochloride. Additional details are available on the levobupivacaine hydrochloride profile page.

Summary for 020997

Tradename:	CHIROCAINE
Applicant:	Purdue Pharma Lp
Ingredient:	levobupivacaine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 5, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 5, 1999	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 7.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 5, 1999	TE:		RLD:	No

Expired US Patents for NDA 020997

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	CHIROCAINE	levobupivacaine hydrochloride	INJECTABLE;INJECTION	020997-003	Aug 5, 1999	⤷ Try a Trial	⤷ Try a Trial
Purdue Pharma Lp	CHIROCAINE	levobupivacaine hydrochloride	INJECTABLE;INJECTION	020997-001	Aug 5, 1999	⤷ Try a Trial	⤷ Try a Trial
Purdue Pharma Lp	CHIROCAINE	levobupivacaine hydrochloride	INJECTABLE;INJECTION	020997-002	Aug 5, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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