AM REGENT Application 207568

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-1171	epinephrine	epinephrine	American Regent, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
62308	ORIG	2020-03-24
55237	ORIG	2018-08-20