FDA ANDA · ANDA210818
METHYLPHENIDATE HYDROCHLORIDE
Sponsor: ALVOGEN
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APPLICATION
ANDA210818
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-30
LATEST ACTION
2026-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 27MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 18MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-01Labeling · Supplement 6 · standardAP
2026-10-01Labeling · Supplement 5 · standardAP
2024-06-03Labeling · Supplement 4 · standardAP
2022-12-27Labeling · Supplement 3 · standardAP
2018-11-30UNKNOWN · Original · standardAP
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