Application 204937

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	5MCG/HR	No	No
002	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	10MCG/HR	No	No
003	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	15MCG/HR	No	No
004	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	20MCG/HR	No	No
005	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	7.5MCG/HR	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3239	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3656	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3657	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3658	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3659	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76430	ORIG	2023-11-07
56848	ORIG	2018-12-20

Application 204937

Related Records#

Application Products#

NDC Listings For This Application#

Documents#