Application 212682

Application Products#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-524	NEBIVOLOL	nebivolol	Solco Healthcare US, LLC	ANDA	Current
43547-525	NEBIVOLOL	nebivolol	Solco Healthcare US, LLC	ANDA	Current
43547-526	NEBIVOLOL	nebibolol	Solco Healthcare US, LLC	ANDA	Current
43547-527	NEBIVOLOL	nebivolol	Solco Healthcare US, LLC	ANDA	Current
63629-9589	NEBIVOLOL	nebivolol	Bryant Ranch Prepack	ANDA	Current