Application 090622

Type: ANDA
Sponsor: ETHYPHARM

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	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-556	buprenorphine hydrochloride	buprenorphine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-1571	buprenorphine hydrochloride	buprenorphine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1571	buprenorphine hydrochloride	buprenorphine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1571	buprenorphine hydrochloride	buprenorphine hydrochloride	A-S Medication Solutions	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., In	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Akorn Operating Company LLC (dba Akorn)	ANDA	Current
50383-924	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., In	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Akorn Operating Company LLC (dba Akorn)	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
50383-930	buprenorphine hydrochloride	buprenorphine hydrochloride	Hi-Tech Pharmacal Co. Inc.	ANDA	Current
53217-246	buprenorphine hydrochloride	buprenorphine hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
63629-7125	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7125	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7126	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7126	buprenorphine hydrochloride	buprenorphine hydrochloride	Bryant Ranch Prepack	ANDA	Current
64725-0930	buprenorphine hydrochloride	buprenorphine hydrochloride	TYA Pharmaceuticals	ANDA	Current
64725-1924	buprenorphine hydrochloride	buprenorphine hydrochloride	TYA Pharmaceuticals	ANDA	Current
67046-990	buprenorphine hydrochloride	buprenorphine hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67046-991	buprenorphine hydrochloride	buprenorphine hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
70518-0442	buprenorphine hydrochloride	buprenorphine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2216	buprenorphine hydrochloride	buprenorphine hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24070	ORIG	2015-07-02