Application 021692

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAM ER	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	No
002	ULTRAM ER	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	Yes	No
003	ULTRAM ER	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10147-0901	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Patriot Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10147-0902	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Patriot Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
10147-0903	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Patriot Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
21695-292	ULTRAM ER	tramadol hydrochloride	Rebel Distributors Corp	NDA	Current
21695-563	ULTRAM ER	tramadol hydrochloride	Rebel Distributors Corp	NDA	Current
21695-913	ULTRAM ER	tramadol hydrochloride	Rebel Distributors Corp	NDA	Current
50458-653	Ultram ER	Tramadol Hydrochloride	Janssen Pharmaceuticals,	NDA	Current
50458-655	Ultram ER	Tramadol Hydrochloride	Janssen Pharmaceuticals,	NDA	Current
50458-657	Ultram ER	Tramadol Hydrochloride	Janssen Pharmaceuticals,	NDA	Current