XGEN PHARMS Application 202402

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN LYSINE	IBUPROFEN LYSINE	INJECTABLE;INTRAVENOUS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
39822-1030	Ibuprofen Lysine	Ibuprofen Lysine	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-1030	Ibuprofen Lysine	Ibuprofen Lysine	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-1030	Ibuprofen Lysine	Ibuprofen Lysine	XGen Pharmaceuticals DJB, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
19343	ORIG	2016-04-11
10043	ORIG	2016-04-01