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FDA ANDA · ANDA201231
DEXMETHYLPHENIDATE HYDROCHLORIDE
Sponsor: SUN PHARM INDUSTRIES
APPLICATION
ANDA201231
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-24
LATEST ACTION
2024-02-27
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
2024-02-27Labeling · Supplement 17 · standardAP
2023-07-24Labeling · Supplement 13 · standardAP
2023-07-24Labeling · Supplement 11 · standardAP
2019-11-29Labeling · Supplement 9 · standardAP
2019-11-29Labeling · Supplement 3 · 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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