Application 021777

Type: NDA
Sponsor: TEVA PHARMS INTL

Related Records

Company: TEVA PHARMS INTL

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
002	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
21695-723	AMRIX	Cyclobenzaprine Hydrochloride	Rebel Distributors Corp.	NDA	Current
21695-953	AMRIX	Cyclobenzaprine Hydrochloride	Rebel Distributors Corp	NDA	Current
35356-262	Amrix	Cyclobenzaprine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-1101	AMRIX	Cyclobenzaprine Hydrochloride	A-S Medication Solutions	NDA	Current
55700-981	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, LLC	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-700	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-701	AMRIX	Cyclobenzaprine Hydrochloride	Cephalon, LLC	NDA	Current
63629-8206	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8206	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
72189-362	Cyclobenzaprine HCL ER	Cyclobenzaprine HCL ER	Direct_Rx	NDA	Current
72189-389	Cyclobenzaprine HCL ER	Cyclobenzaprine HCL ER	Direct_Rx	NDA AUTHORIZED GENERIC	Current

Documents

Document	Submission type	Date
78282	SUPPL	2024-04-26
78280	SUPPL	2024-04-26
58429	SUPPL	2019-04-26
58408	SUPPL	2019-04-25
37627	SUPPL	2016-06-01
28577	SUPPL	2016-05-27
37625	SUPPL	2013-06-11
16355	SUPPL	2013-06-11
6167	SUPPL	2013-06-11
6166	SUPPL	2013-06-11
37626	SUPPL	2013-04-16
6168	SUPPL	2013-04-16
21815	ORIG	2008-05-06
6165	SUPPL	2008-03-26
6164	ORIG	2007-02-12
16354	ORIG	2007-02-02