Application 021475

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLINMETHYLPHENIDATE HYDROCHLORIDETABLET, CHEWABLE;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002METHYLINMETHYLPHENIDATE HYDROCHLORIDETABLET, CHEWABLE;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003METHYLINMETHYLPHENIDATE HYDROCHLORIDETABLET, CHEWABLE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80845SUPPL 2025-01-13
80826SUPPL 2025-01-10
80824SUPPL 2025-01-10
75803SUPPL 2023-10-17
75761SUPPL 2023-10-16
67930SUPPL2021-06-28
67929SUPPL2021-06-28
46832SUPPL2017-01-13
46831SUPPL2017-01-13
46709SUPPL2017-01-06
37031SUPPL2015-04-21
5484SUPPL2015-04-20
27894SUPPL2013-12-24
15556SUPPL2013-12-17
37030SUPPL2013-06-18
5483SUPPL2013-06-18
23665ORIG2011-12-20
5482SUPPL2010-10-20
37029SUPPL2010-10-18
5481SUPPL2007-06-14
37028SUPPL2007-06-12
5480SUPPL2006-08-14
15555SUPPL2006-08-11
21682ORIG2006-07-25
37027ORIG2003-04-17