APPLICATION
ANDA205756
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-07
LATEST ACTION
2026-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 2.5MG · TABLET, CHEWABLE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET, CHEWABLE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
Approval history
2026-04-29Labeling · Supplement 9 · standardAP
2023-10-13Labeling · Supplement 8 · standardAP
2021-06-25Labeling · Supplement 7 · standardAP
2021-06-22Labeling · Supplement 2 · standardAP
2016-11-07UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.