APPLICATION
ANDA206840
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-15
LATEST ACTION
2024-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2024-06-03Labeling · Supplement 6 · standardAP
2022-09-21Labeling · Supplement 5 · standardAP
2022-09-21Labeling · Supplement 4 · standardAP
2022-09-21Labeling · Supplement 2 · standardAP
2016-09-15UNKNOWN · 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.