APPLICATION
ANDA091159
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-12
LATEST ACTION
2026-01-15
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
2026-01-15Labeling · Supplement 10 · standardAP
2026-01-15Labeling · Supplement 17 · standardAP
2026-01-15Labeling · Supplement 3 · standardAP
2026-01-15Labeling · Supplement 1 · standardAP
2026-01-15Labeling · Supplement 18 · standardAP
2026-01-15Labeling · Supplement 16 · standardAP
2026-01-15Labeling · Supplement 14 · standardAP
2026-01-15Labeling · Supplement 12 · standardAP
2014-03-12OriginalAP
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.
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