Application 090410

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	CAPSULE;ORAL	3MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7155	Budesonide	budesonide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7155	Budesonide	budesonide	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-020	Budesonide	budesonide	Mylan Institutional Inc.	ANDA	Current
51079-020	Budesonide	budesonide	Mylan Institutional Inc.	ANDA	Current
51079-020	Budesonide	budesonide	Mylan Institutional Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
60429-264	Budesonide	budesonide	Golden State Medical Supply, Inc.	ANDA	Current
68151-4374	Budesonide	budesonide	Carilion Materials Management	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
22708	ORIG	2012-10-12
43239	ORIG	2012-09-26