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FDA ANDA · ANDA202580
DEXMETHYLPHENIDATE HYDROCHLORIDE
Sponsor: AUROLIFE PHARMA LLC
APPLICATION
ANDA202580
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-28
LATEST ACTION
2026-03-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-03-19Labeling · Supplement 8 · standardAP
2026-03-19Labeling · Supplement 6 · standardAP
2026-03-19Labeling · Supplement 9 · standardAP
2019-11-29Labeling · Supplement 4 · standardAP
2019-11-29Labeling · Supplement 5 · standardAP
2015-11-12Labeling · Supplement 3 · standardAP
2014-01-23Labeling · Supplement 2 · 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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