APPLICATION
ANDA213473
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-29
LATEST ACTION
2024-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 18MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 27MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-04-11Labeling · Supplement 2 · standardAP
2022-12-22Labeling · Supplement 1 · standardAP
2020-07-29UNKNOWN · 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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