FDA.reportPublic FDA data

Application 021278

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOCALINDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL2.5MGYesNo
002FOCALINDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGYesNo
003FOCALINDEXMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0380Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0381Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0382Focalindexmethylphenidate hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0781-5676Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5676Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5689Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5689Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5691Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5691Dexmethylphenidate HydrochlorideDexmethylphenidate HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75815SUPPL 2023-10-17
75814SUPPL 2023-10-17
75813SUPPL 2023-10-17
75751SUPPL 2023-10-16
75750SUPPL 2023-10-16
67971SUPPL2021-06-29
67970SUPPL2021-06-29
67953SUPPL2021-06-29
60985SUPPL2019-11-20
60980SUPPL2019-11-20
60979SUPPL2019-11-20
57271SUPPL2019-01-18
57270SUPPL2019-01-18
57176SUPPL2019-01-11
57175SUPPL2019-01-11
57174SUPPL2019-01-11
57173SUPPL2019-01-11
46753SUPPL2017-01-10
46752SUPPL2017-01-10
46702SUPPL2017-01-06
36556SUPPL2015-04-21
27346SUPPL2015-04-20
36555SUPPL2013-12-17
27345SUPPL2013-12-13
14855SUPPL2013-06-18
27344SUPPL2013-06-12
36554SUPPL2012-05-07
4878SUPPL2012-05-04
4877SUPPL2010-12-15
36553SUPPL2010-12-10
4876SUPPL2010-11-22
36552SUPPL2010-11-19
44110ORIG2007-05-10
36551SUPPL2007-05-01
27343SUPPL2007-05-01
14854SUPPL2007-03-15
4875SUPPL2007-03-15
27342SUPPL2006-09-18
4874SUPPL2006-09-18
14853SUPPL2006-08-29
14852SUPPL2006-08-29
27341ORIG2001-11-13
21569ORIG2001-11-13
14851ORIG2001-11-13