APPLICATION
ANDA040220
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-29
LATEST ACTION
2014-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2014-02-24Labeling · Supplement 30 · standardAP
2014-02-24Labeling · Supplement 31 · standardAP
2009-12-01Labeling · Supplement 19AP
2008-09-23Labeling · Supplement 16AP
2003-01-21Labeling · Supplement 10AP
2001-04-20Labeling · Supplement 8AP
1999-09-02Labeling · Supplement 7AP
1998-08-19Labeling · Supplement 5AP
1998-03-25Manufacturing (CMC) · Supplement 3AP
1998-03-25Manufacturing (CMC) · Supplement 1AP
1998-03-25Manufacturing (CMC) · Supplement 2AP
1997-08-29OriginalAP
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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