Application 202873

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOZAPINE	CLOZAPINE	TABLET;ORAL	25MG	No	No
002	CLOZAPINE	CLOZAPINE	TABLET;ORAL	100MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-141	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-141	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-141	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-141	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-142	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-142	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-142	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current
16729-142	Clozapine	clozapine	Accord Healthcare Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44585	ORIG	2015-11-30
10125	ORIG	2015-11-30