Application 201066

Type: ANDA
Sponsor: MYLAN

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
0378-0923	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0923	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0924	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0924	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	Mylan Pharmaceuticals Inc.	ANDA	Current
67046-996	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	Contract Pharmacy Services-PA	ANDA	Current
67046-997	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	Contract Pharmacy Services-PA	ANDA	Current
70518-0652	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44573	ORIG	2015-07-02