APPLICATION
ANDA040300
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-27
LATEST ACTION
2016-10-28
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
2016-10-28Labeling · Supplement 17 · standardAP
2016-10-28Labeling · Supplement 18 · standardAP
2015-03-20Labeling · Supplement 15 · standardAP
2014-01-21Labeling · Supplement 13 · standardAP
2012-12-19Labeling · Supplement 11AP
2010-12-10Labeling · Supplement 7AP
2006-03-02Labeling · Supplement 6AP
2003-04-24Labeling · 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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