APPLICATION
ANDA090710
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-15
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2024-02-28Labeling · Supplement 28 · standardAP
2024-02-28Labeling · Supplement 25 · standardAP
2020-01-08Labeling · Supplement 12 · standardAP
2020-01-08Labeling · Supplement 10 · standardAP
2020-01-08Labeling · Supplement 19 · standardAP
2020-01-08Labeling · Supplement 23 · standardAP
2020-01-08Labeling · Supplement 15 · standardAP
2014-01-16Labeling · Supplement 7 · standardAP
2012-03-15OriginalAP
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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