TORRENT Application 208272

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
13668-476	Roflumilast	Roflumilast	Torrent Pharmaceuticals Limited	ANDA	Current
13668-476	Roflumilast	Roflumilast	Torrent Pharmaceuticals Limited	ANDA	Current