APPLICATION
ANDA212288
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-06
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-09-23Labeling · Supplement 4 · standardAP
2021-06-25Labeling · Supplement 1 · standardAP
2020-10-06UNKNOWN · 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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