AXSOME THERAPEUTICS, INC. Application 215430

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUVELITY	DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	45MG/105MG	No	No
002	AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	105MG;30MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81968-045	AUVELITY	dextromethorphan hydrobromide, bupropion hydrochloride	Axsome Therapeutics, Inc.	NDA	Current
81968-045	AUVELITY	dextromethorphan hydrobromide, bupropion hydrochloride	Axsome Therapeutics, Inc.	NDA	Current
81968-045	AUVELITY	dextromethorphan hydrobromide, bupropion hydrochloride	Axsome Therapeutics, Inc.	NDA	Current