APPLICATION
ANDA208737
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-01
LATEST ACTION
2024-04-01
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
2024-04-01Labeling · Supplement 2 · standardAP
2022-12-16Labeling · Supplement 1 · standardAP
2019-02-01UNKNOWN · 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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