Application 021284

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
002	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
003	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
004	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
005	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83504	SUPPL	2025-09-25
83503	SUPPL	2025-09-25
83443	SUPPL	2025-09-25
75817	SUPPL	2023-10-17
75749	SUPPL	2023-10-16
75748	SUPPL	2023-10-16
67973	SUPPL	2021-06-29
67972	SUPPL	2021-06-29
67952	SUPPL	2021-06-29
60992	SUPPL	2019-11-20
60991	SUPPL	2019-11-20
60984	SUPPL	2019-11-20
57269	SUPPL	2019-01-18
57268	SUPPL	2019-01-18
57192	SUPPL	2019-01-11
57191	SUPPL	2019-01-11
57190	SUPPL	2019-01-11
57189	SUPPL	2019-01-11
46828	SUPPL	2017-01-13
46827	SUPPL	2017-01-13
46704	SUPPL	2017-01-06
36575	SUPPL	2015-04-21
4907	SUPPL	2015-04-21
36574	SUPPL	2014-12-19
4906	SUPPL	2014-11-10
14878	SUPPL	2013-12-17
4905	SUPPL	2013-12-16
27369	SUPPL	2013-06-11
14876	SUPPL	2013-06-11
4904	SUPPL	2013-05-07
14877	SUPPL	2013-05-06
4903	SUPPL	2010-12-15
36573	SUPPL	2010-12-10
27368	SUPPL	2010-11-18
14875	SUPPL	2010-11-17
14873	SUPPL	2010-05-07
4902	SUPPL	2010-04-29
23641	ORIG	2007-05-10
27367	SUPPL	2007-05-01
14874	SUPPL	2007-05-01
4901	SUPPL	2006-08-11
4900	SUPPL	2006-08-11
14872	SUPPL	2006-08-09
14871	SUPPL	2006-08-09
4899	SUPPL	2004-04-20
42080	ORIG	2002-11-20
36572	ORIG	2002-06-05
27366	ORIG	2002-06-05

Application 021284

Related Records#

Application Products#

NDC Listings For This Application#

Documents#