APPLICATION
ANDA206931
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-04
LATEST ACTION
2024-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2024-09-10Labeling · Supplement 10 · standardAP
2023-05-08Labeling · Supplement 6 · standardAP
2015-12-04UNKNOWN · Original · standardAP
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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