Application 090308

Type: ANDA
Sponsor: BARR LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	No	No
002	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	No	Yes
003	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	12.5MG	No	No
004	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	150MG	No	No
005	CLOZAPINE	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	200MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5416	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5417	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5419	Clozapine	Clozapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54157	ORIG	2018-05-11
44549	ORIG	2015-11-30
9265	ORIG	2015-11-30