MYLAN SPECIALITY LP Application 020136

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEMADEX	TORSEMIDE	TABLET;ORAL	5MG	Yes	No
002	DEMADEX	TORSEMIDE	TABLET;ORAL	10MG	Yes	No
003	DEMADEX	TORSEMIDE	TABLET;ORAL	20MG	Yes	Yes
004	DEMADEX	TORSEMIDE	TABLET;ORAL	100MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-3500	Demadex	Torsemide	Meda Pharmaceuticals	NDA	Current
0037-3500	Demadex	Torsemide	Meda Pharmaceuticals	NDA	Current
0037-3510	Demadex	Torsemide	Meda Pharmaceuticals	NDA	Current