HANSAMED INC Application 201751

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTACAN	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52120-200	Ultacan	articaine hydrochloride, epinephrine bitartrate	HANSAmed, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
48968	ORIG	2017-07-13
48951	ORIG	2017-07-11