FDA ANDA · ANDA206840
METHYLPHENIDATE HYDROCHLORIDE
Sponsor: ALVOGEN
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APPLICATION
ANDA206840
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-15
LATEST ACTION
2026-10-02
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
2026-10-02Labeling · Supplement 7 · standardAP
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
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