FDA ANDA · ANDA209276
METHYLPHENIDATE HYDROCHLORIDE
Sponsor: AUROLIFE PHARMA LLC
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APPLICATION
ANDA209276
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-25
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2026-10-16Labeling · Supplement 2 · standardAP
2018-10-25UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →