Application 021802

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	Yes	No
002	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
003	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
004	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
005	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
006	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	Yes
007	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	Yes	No
008	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-2682	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2682	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2682	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2683	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2683	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2683	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2684	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2684	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2684	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2686	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2686	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2686	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2687	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2687	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2687	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2688	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2688	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2688	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2689	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2689	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2689	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
69189-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Avera McKennan Hospital	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83502	SUPPL	2025-09-25
83501	SUPPL	2025-09-25
83442	SUPPL	2025-09-25
75816	SUPPL	2023-10-17
75811	SUPPL	2023-10-17
75753	SUPPL	2023-10-16
75752	SUPPL	2023-10-16
67975	SUPPL	2021-06-29
67974	SUPPL	2021-06-29
67951	SUPPL	2021-06-29
60986	SUPPL	2019-11-20
60981	SUPPL	2019-11-20
60978	SUPPL	2019-11-20
57273	SUPPL	2019-01-18
57272	SUPPL	2019-01-18
57180	SUPPL	2019-01-11
57179	SUPPL	2019-01-11
57178	SUPPL	2019-01-11
57177	SUPPL	2019-01-11
46755	SUPPL	2017-01-10
46754	SUPPL	2017-01-10
46703	SUPPL	2017-01-06
16405	SUPPL	2015-04-21
6230	SUPPL	2015-04-20
37683	SUPPL	2013-12-17
6229	SUPPL	2013-12-13
37682	SUPPL	2013-06-18
28632	SUPPL	2013-06-12
16404	SUPPL	2012-05-07
6228	SUPPL	2012-05-04
37681	SUPPL	2011-11-29
6227	SUPPL	2010-11-22
16403	SUPPL	2010-11-19
28631	SUPPL	2010-05-07
16402	SUPPL	2010-05-07
6226	SUPPL	2009-12-11
6225	SUPPL	2009-12-11
37680	SUPPL	2009-10-30
16401	SUPPL	2009-10-30
28630	SUPPL	2008-10-22
21822	ORIG	2007-07-02
23678	ORIG	2007-05-10
37679	SUPPL	2007-05-01
6224	SUPPL	2007-05-01
37678	SUPPL	2006-08-04
28629	SUPPL	2006-08-04
16400	SUPPL	2006-08-04
6223	SUPPL	2006-08-04
28628	SUPPL	2006-04-13
6222	SUPPL	2006-04-13
37677	SUPPL	2006-04-12
16399	SUPPL	2006-04-12
28627	ORIG	2005-06-07
16398	ORIG	2005-06-07
53229	ORIG	1900-01-01
53228	ORIG	1900-01-01
53227	ORIG	1900-01-01

Application 021802

Related Records#

Application Products#

NDC Listings For This Application#

Documents#