Application 075616

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIZATIDINE	NIZATIDINE	CAPSULE;ORAL	150MG	No	No
002	NIZATIDINE	NIZATIDINE	CAPSULE;ORAL	300MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3137	Nizatidine	Nizatidine	Actavis Pharma, Inc.	ANDA	Current
0591-3138	Nizatidine	Nizatidine	Actavis Pharma, Inc.	ANDA	Current
21695-043	Nizatidine	Nizatidine	Rebel Distributors Corp	ANDA	Current
42254-093	Nizatidine	Nizatidine	Rebel Distributors Corp	ANDA	Current
52959-824	Nizatidine	Nizatidine	H.J. Harkins Company, Inc.	ANDA	Current
68071-5043	Nizatidine	Nizatidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5043	Nizatidine	Nizatidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-0017	Nizatidine	Nizatidine	Carilion Materials Management	ANDA	Current
68258-3006	Nizatidine	Nizatidine	Dispensing Solutions Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
30958	ORIG	2004-06-10