APOTEX Application 202958

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-3518	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3518	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3518	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current
60505-3518	Levetiracetam	Levetiracetam	Apotex Corp.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
40242	ORIG	2015-03-12
10136	ORIG	2015-03-04