Application 078633

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 2MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8MG BASE	No	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0176	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0177	Buprenorphine HCl	Buprenorphine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0904-7154	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7154	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7154	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7155	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7155	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
0904-7155	Buprenorphine HCl	Buprenorphine HCl	Major Pharmaceuticals	ANDA	Current
55700-302	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-302	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-302	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-303	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-303	Buprenorphine HCl	Buprenorphine HCl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0176	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0176	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0176	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0177	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0177	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0177	Buprenorphine HCl	Buprenorphine HCl	Clinical Solutions Wholesale, LLC	ANDA	Current
67046-998	Buprenorphine HCl	Buprenorphine HCl	Contract Pharmacy Services-PA	ANDA	Current
67046-999	Buprenorphine HCl	Buprenorphine HCl	Contract Pharmacy Services-PA	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2014	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2226	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2226	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
70518-2226	Buprenorphine HCl	Buprenorphine HCl	REMEDYREPACK INC.	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
71335-1163	Buprenorphine HCl	Buprenorphine HCl	Bryant Ranch Prepack	ANDA	Current
76519-1170	BUPRENORPHINE HCL	BUPRENORPHINE HCL	H.J. Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44539	ORIG	2015-07-02
31378	ORIG	2009-10-14