NDA 21419, held by Specgx LLC. Methylphenidate Hydrochloride.
As of Nov 15, 2026, NDA 21419 (Methylin), held by Specgx LLC, was first approved by FDA on Dec 19, 2002, with 11 approved supplements and 0 published complete response letters.
Methylin is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older Narcolepsy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Methylin5MG/5ML · solution;oral | Methylphenidate Hydrochloride | RxReference drug |
| Methylin10MG/5ML · solution;oral | Methylphenidate Hydrochloride | RxReference drug |
| Oct 13, 2023 | Supplement 23Labeling · Standard review | Approved | |
| Jul 19, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Jun 25, 2021 | Supplement 20Labeling | Approved | |
| Jan 4, 2017 | Supplement 14Labeling | Approved | |
| Apr 17, 2015 | Supplement 9Labeling | Approved | |
| Sep 15, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2013 | Supplement 7Labeling · Standard review | Approved | |
| Jun 14, 2013 | Supplement 6Labeling · Standard review | Approved | |
| Oct 18, 2010 | Supplement 4Labeling | Approved | |
| Jun 7, 2007 | Supplement 1Labeling · Standard review | Approved | |
| Aug 10, 2006 | Supplement 3Labeling · Standard review | Approved | |
| Dec 19, 2002 | Original applicationNew dosage form · Standard review | Approved |
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
