APPLICATION
ANDA076032
TYPE
ANDA
ORIGINAL APPROVAL
2001-05-09
LATEST ACTION
2003-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2003-11-18Labeling · Supplement 3AP
2003-03-05Labeling · Supplement 2AP
2001-10-16Manufacturing (CMC) · Supplement 1AP
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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