APPLICATION
ANDA206932
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-11
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-07-17Labeling · Supplement 20 · standardAP
2024-06-03Labeling · Supplement 14 · standardAP
2022-09-21Labeling · Supplement 7 · standardAP
2017-05-11UNKNOWN · 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.
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