MYLAN Application 208257

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROFLUMILAST	ROFLUMILAST	TABLET;ORAL	500MCG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1905	Roflumilast	Roflumilast	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1905	Roflumilast	Roflumilast	Mylan Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
48651	ORIG	2017-06-06