Application 201760

Type: ANDA
Sponsor: SUN PHARM

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
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-459	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-460	Buprenorphine	Buprenorphine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
70518-0711	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
70518-0711	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current
70518-0711	Buprenorphine	Buprenorphine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44575	ORIG	2016-02-03
32137	ORIG	2016-02-01