Application 210609

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TADALAFIL	TADALAFIL	TABLET;ORAL	2.5MG	No	No
002	TADALAFIL	TADALAFIL	TABLET;ORAL	5MG	No	No
003	TADALAFIL	TADALAFIL	TABLET;ORAL	10MG	No	No
004	TADALAFIL	TADALAFIL	TABLET;ORAL	20MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-047	TADALAFIL	tadalafil	Solco Healthcare US, LLC	ANDA	Current
43547-049	TADALAFIL	tadalafil	Solco Healthcare US, LLC	ANDA	Current
43547-050	TADALAFIL	tadalafil	Solco Healthcare US, LLC	ANDA	Current
43547-051	TADALAFIL	tadalafil	Solco Healthcare US, LLC	ANDA	Current