Methylin

NDA 21475, held by Specgx LLC. Methylphenidate Hydrochloride.

As of Nov 14, 2026, NDA 21475 (Methylin), held by Specgx LLC, was first approved by FDA on Apr 15, 2003, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 15, 2003
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 15, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label

Products

3 strengths and forms


Methylin2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Methylphenidate Hydrochloride	DiscontinuedReference drug
Methylin5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Methylphenidate Hydrochloride	DiscontinuedReference drug
Methylin10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Methylphenidate Hydrochloride	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Jan 8, 2025	Supplement 13Labeling · Standard review	Approved	Medication Guide Label Letter
Oct 13, 2023	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 25, 2021	Supplement 11Labeling	Approved	Label
Jan 4, 2017	Supplement 10Labeling	Approved	Letter Label
Apr 17, 2015	Supplement 9Labeling	Approved	Label Letter
Sep 15, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 12, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Jun 14, 2013	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 18, 2010	Supplement 5Labeling	Approved	Letter Label
Jun 7, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Aug 10, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 15, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label

Identifiers

Application: NDA 21475
Drugs@FDA: Overview at FDA
Company: SpecGx

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters