Application 021610

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
006	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-948	OPANA ER	Oxymorphone Hydrochloride	Rebel Distributors Corp	NDA	Current
21695-949	OPANA ER	Oxymorphone Hydrochloride	Rebel Distributors Corp	NDA	Current
63629-4174	Opana ER	OXYMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	NDA	Current
63629-4177	OPANA	Oxymorphone Hydrochloride	Bryant Ranch Prepack	NDA	Current