Application 078879

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	5MG	No	No
002	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	20MG	No	No
003	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	100MG	No	No
004	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	250MG	No	No
005	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	140MG	No	No
006	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	180MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7599	Temozolomide	Temozolomide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7600	Temozolomide	Temozolomide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7601	Temozolomide	Temozolomide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7602	Temozolomide	Temozolomide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7638	Temozolomide	Temozolomide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7639	Temozolomide	Temozolomide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
23155-774	Temozolomide	Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-775	Temozolomide	Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-776	Temozolomide	Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-777	Temozolomide	Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-778	Temozolomide	Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-779	Temozolomide	Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
43151	ORIG	2013-05-15