Application 005378

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	Yes
003	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
004	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
005	DESOXYN	METHAMPHETAMINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-104	Desoxyn	methamphetamine hydrochloride	Recordati Rare Diseases Inc.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	Recordati Rare Diseases, Inc.	NDA	Current
55292-104	Desoxyn	methamphetamine hydrochloride	RECORDATI RARE DISEASES, INC.	NDA	Current
70868-820	Desoxyn	methamphetamine hydrochloride	Key Therapeutics	NDA	Current