Application 079087

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1231	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1232	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1233	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1234	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1315	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1316	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Impax Generics	ANDA	Current
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1317	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
55700-215	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Qua	ANDA	Current
55700-215	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-387	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-417	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-417	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-417	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-417	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-423	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-788	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-788	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-788	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-788	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-788	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-806	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Quality Care Products, LLC	ANDA	Current
64896-695	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-695	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-695	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-695	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-695	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-696	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-696	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-696	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-696	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-696	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-697	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-697	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-697	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
64896-697	Oxymorphone hydrochloride	Oxymorphone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44542	ORIG	2015-06-30

Application 079087

Related Records#

Application Products#

NDC Listings For This Application#

Documents#