Application 021381

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYLOCAINE DENTAL WITH EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	XYLOCAINE DENTAL WITH EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/ML;2% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021381-001	XYLOCAINE DENTAL WITH EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982
N021381-002	XYLOCAINE DENTAL WITH EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.02MG/ML;2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982

Document, Submission type, Date table
Document	Submission type	Date
60026	SUPPL	2019-09-17