Application 010187

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
006	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	No
010	RITALIN	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0439	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0440	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0441	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5748	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5748	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5749	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5749	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5753	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5753	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
63629-3166	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3166	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0838	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0838	Methylphenidate Hydrochloride	methylphenidate hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81055	SUPPL	2025-02-06
81054	SUPPL	2025-02-06
80962	SUPPL	2025-02-05
75819	SUPPL	2023-10-17
75818	SUPPL	2023-10-17
75747	SUPPL	2023-10-16
75746	SUPPL	2023-10-16
67969	SUPPL	2021-06-29
67968	SUPPL	2021-06-29
67950	SUPPL	2021-06-29
60988	SUPPL	2019-11-20
60987	SUPPL	2019-11-20
60982	SUPPL	2019-11-20
57265	SUPPL	2019-01-18
57264	SUPPL	2019-01-18
57184	SUPPL	2019-01-11
57183	SUPPL	2019-01-11
57182	SUPPL	2019-01-11
57181	SUPPL	2019-01-11
46824	SUPPL	2017-01-13
46823	SUPPL	2017-01-13
46705	SUPPL	2017-01-06
33014	SUPPL	2015-04-21
216	SUPPL	2015-04-21
10748	SUPPL	2013-12-17
11896	SUPPL	2013-12-16
33013	SUPPL	2013-06-11
215	SUPPL	2013-06-11
214	SUPPL	2010-12-15
33012	SUPPL	2010-12-10
213	SUPPL	2010-11-18
10747	SUPPL	2010-11-17
23528	ORIG	2007-05-10
10746	SUPPL	2007-05-01
212	SUPPL	2007-05-01
211	SUPPL	2006-08-11
210	SUPPL	2006-08-11
10745	SUPPL	2006-08-09
10744	SUPPL	2006-08-09
208	SUPPL	2004-05-27
207	SUPPL	2004-05-27
209	SUPPL	2002-01-11

Application 010187

Related Records#

Application Products#

NDC Listings For This Application#

Documents#