PROMIUS PHARMA Application 018917

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SECTRAL	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG BASE	Yes	No
003	SECTRAL	ACEBUTOLOL HYDROCHLORIDE	CAPSULE;ORAL	EQ 400MG BASE	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67857-700	SECTRAL	acebutolol hydrochloride	Promius Pharma, LLC	NDA	Current
67857-701	SECTRAL	acebutolol hydrochloride	Promius Pharma, LLC	NDA	Current