MSN LABORATORIES Application 208256

Application Products#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72205-200	Roflumilast	Roflumilast	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-201	Roflumilast	Roflumilast	Novadoz Pharmaceuticals LLC	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
54445	ORIG	2018-06-05