Details for New Drug Application (NDA): 014763

NDA 014763 describes CITANEST PLAIN, which is a drug marketed by Astrazeneca and Dentsply Pharm and is included in two NDAs. Additional details are available on the CITANEST PLAIN profile page.

The generic ingredient in CITANEST PLAIN is prilocaine hydrochloride. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prilocaine hydrochloride profile page.

Summary for 014763

Tradename:	CITANEST PLAIN
Applicant:	Astrazeneca
Ingredient:	epinephrine bitartrate; prilocaine hydrochloride
Patents:	0

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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