Application 208247

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	250MCG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-786	roflumilast	ROFLUMILAST	Strides Pharma Science Limited	ANDA	Current
64380-786	roflumilast	ROFLUMILAST	Strides Pharma Science Limited	ANDA	Current