Application 020234

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEGRETOL-XR	CARBAMAZEPINE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	No
002	TEGRETOL-XR	CARBAMAZEPINE	TABLET, EXTENDED RELEASE;ORAL	200MG	Yes	No
003	TEGRETOL-XR	CARBAMAZEPINE	TABLET, EXTENDED RELEASE;ORAL	400MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0510	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0511	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0512	Tegretol	carbamazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5987	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5987	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5987	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5987	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5988	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5988	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5988	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5988	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8016	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8016	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8016	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8016	Carbamazepine	Carbamazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
68084-561	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-561	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-561	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-561	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-562	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-562	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-562	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-562	Carbamazepine	Carbamazepine	American Health Packaging	NDA AUTHORIZED GENERIC	Current
70518-0337	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current
70518-0337	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current
70518-0337	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current
70518-0337	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current
70518-2653	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2653	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2653	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3266	Tegretol	carbamazepine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83617	SUPPL	2025-10-01
83615	SUPPL	2025-10-01
83614	SUPPL	2025-10-01
75462	SUPPL	2023-09-14
75451	SUPPL	2023-09-14
53453	SUPPL	2018-03-27
53422	SUPPL	2018-03-26
53147	SUPPL	2018-03-22
12338	SUPPL	2015-09-03
24616	SUPPL	2015-09-01
34398	SUPPL	2014-09-19
24617	SUPPL	2014-09-17
34400	SUPPL	2014-01-17
2209	SUPPL	2014-01-17
34401	SUPPL	2013-03-08
2210	SUPPL	2013-03-08
12342	SUPPL	2012-12-13
2211	SUPPL	2012-12-13
24620	SUPPL	2011-11-10
24619	SUPPL	2011-03-07
12341	SUPPL	2011-03-07
12340	SUPPL	2011-03-07
2208	SUPPL	2011-03-07
34399	SUPPL	2009-05-12
24618	SUPPL	2009-05-01
2207	SUPPL	2008-01-09
12339	SUPPL	2007-12-12
24615	SUPPL	2007-08-17
12337	SUPPL	2007-08-17
41219	SUPPL	2007-07-06
41218	ORIG	2004-12-08
24614	ORIG	2004-12-08
12336	ORIG	2004-12-08
34397	SUPPL	2001-03-07
2206	SUPPL	2001-03-07

Application 020234

Related Records#

Application Products#

NDC Listings For This Application#

Documents#