FDA.reportPublic FDA data

Application 021419

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLINMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL5MG/5MLYesYes
002METHYLINMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL10MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-3005Methylphenidate HClMethylphenidate HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3005Methylphenidate HCl Oral SolutionMethylphenidate HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3005Methylphenidate HCl Oral SolutionMethylphenidate HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3010Methylphenidate HClMethylphenidate HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3010Methylphenidate HCl Oral SolutionMethylphenidate HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
0406-3010Methylphenidate HCl Oral SolutionMethylphenidate HydrochlorideSpecGx LLCNDA AUTHORIZED GENERICCurrent
59630-750MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-750MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-750MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-750MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-750MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-755MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-755MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-755MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-755MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent
59630-755MethylinMethylphenidate HydrochlorideSHIONOGI INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75802SUPPL 2023-10-17
75801SUPPL 2023-10-17
75762SUPPL 2023-10-16
68130SUPPL2021-07-20
68129SUPPL2021-07-20
68122SUPPL2021-07-20
67944SUPPL2021-06-29
67932SUPPL2021-06-28
67931SUPPL2021-06-28
46830SUPPL2017-01-13
46829SUPPL2017-01-13
46708SUPPL2017-01-06
36869SUPPL2015-04-21
5314SUPPL2015-04-20
5313SUPPL2013-12-24
15419SUPPL2013-12-17
15418SUPPL2013-06-18
5312SUPPL2013-06-18
23657ORIG2011-12-20
5311SUPPL2010-10-20
15417SUPPL2010-10-18
5309SUPPL2007-06-14
15416SUPPL2007-06-12
5310SUPPL2006-08-14
36868SUPPL2006-08-11
42145ORIG2004-10-26
5308ORIG2002-12-19