APPLICATION
ANDA075450
TYPE
ANDA
ORIGINAL APPROVAL
2001-12-21
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-09-23Labeling · Supplement 9 · standardAP
2021-06-25Labeling · Supplement 8 · standardAP
2001-12-21OriginalAP
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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