← FDA DRUG APPROVALS

FDA ANDA · ANDA078992

DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE

dexmethylphenidate hydrochloride

Sponsor: PLATINUM

APPLICATION

ANDA078992

TYPE

ANDA

ORIGINAL APPROVAL

2013-11-18

LATEST ACTION

2021-11-23

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription

DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription

DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription

DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription

DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription

DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription

DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2021-11-23OriginalAP

2019-11-29Labeling · Supplement 3 · standardAP

2019-11-29Labeling · Supplement 4 · standardAP

2015-06-30Labeling · Supplement 2 · standardAP

2014-08-22Labeling · Supplement 1 · standardAP

2013-11-18Original — Letter ↗AP

VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →