Application 201742

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	140MG	No	No
005	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	180MG	No	No
006	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	250MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-890	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-890	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-890	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-891	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-891	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-891	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-892	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-892	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-892	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-893	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-893	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-893	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-929	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-929	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-929	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-930	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-930	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-930	Temozolomide	Temozolomide	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
32134	ORIG	2014-02-13