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Life sciences · Regulatory label update
U.S. Food and Drug Administration · October 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Regulatory label update.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA209276. This is a regulatory action record, not a clinical study. Brand name: METHYLPHENIDATE HYDROCHLORIDE. Active ingredient: METHYLPHENIDATE HYDROCHLORIDE. Sponsor: AUROLIFE PHARMA LLC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-10-16. Products: METHYLPHENIDATE HYDROCHLORIDE, TABLET, ORAL, METHYLPHENIDATE HYDROCHLORIDE 5MG; METHYLPHENIDATE HYDROCHLORIDE, TABLET, ORAL, METHYLPHENIDATE HYDROCHLORIDE 10MG; METHYLPHENIDATE HYDROCHLORIDE, TABLET, ORAL, METHYLPHENIDATE HYDROCHLORIDE 20MG.