Application 200822

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	40MG	No	No
002	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
003	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	7.5MG	No	No
004	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
005	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No
006	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG	No	No
007	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24097	ORIG	2015-06-30
22840	ORIG	2015-03-11