APPLICATION
ANDA207416
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-22
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2025-09-16Labeling · Supplement 15 · standardAP
2025-09-16Labeling · Supplement 13 · standardAP
2022-09-16Labeling · Supplement 6 · standardAP
2022-09-16Labeling · Supplement 9 · standardAP
2022-09-16Labeling · Supplement 5 · standardAP
2017-08-14Manufacturing (CMC) · Supplement 3 · unknownAP
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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