FDA ANDA · ANDA079108
DEXMETHYLPHENIDATE HYDROCHLORIDE
Sponsor: IMPAX LABS INC
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APPLICATION
ANDA079108
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-21
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-10-05Labeling · Supplement 20 · standardAP
2024-12-17Labeling · Supplement 7 · standardAP
2024-12-17Labeling · Supplement 11 · standardAP
2024-12-17Labeling · Supplement 16 · standardAP
2024-12-17Labeling · Supplement 10 · standardAP
2019-11-29Labeling · Supplement 6 · standardAP
2019-11-29Labeling · Supplement 4 · standardAP
2015-12-28Labeling · Supplement 3 · standardAP
2015-12-21OriginalAP
2015-08-05OriginalAP
2014-05-19OriginalAP
2014-01-22Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →